PROTECT-CH This file contains the metadata, events, and data for REDCap project "PROTECT-CH". PROTECT-CH 1 [consent_arm_1][pt_initials] 1 1 2 1 Developing Resident ID<div style="font-size:110%">Resident ID</div> [msg1] <div class="progress"> <div class="progress-bar" role="progressbar" style="width: 9%" aria-valuenow="9" aria-valuemin="0" aria-valuemax="100">[msg1]</div> </div> Does the Resident have capacity to give consent? <div style="padding-top:10px;font-size:110%;">Does the Resident have capacity to give consent?</div> If resident has lost capacity since giving consent do not amend this form. Please see [form-link:change_resident_capacity_or_plr:Change Resident Capacity]. <div style="padding-top:10px;font-size:110%;color:purple;">If resident has lost capacity since giving consent do not amend this form. Please see [form-link:change_resident_capacity_or_plr:Change Resident Capacity]. </div> Has the residents legal representative given their verbal permission for the PROTECT-CH trial team to use their contact details and to collect the residents name, date of birth and gender? <div style="padding-top:10px;font-size:110%;">Has the residents legal representative given their verbal permission for the PROTECT-CH trial team to use their contact details and to collect the residents name, date of birth and gender? </div> ctype (hidden) Care Home staff who obtained verbal permission from the residents legal representative:  Staff's First name: {staff_firstname:icons} Staff's Last name: {staff_lastname:icons} Date verbal permission obtained {verbal_date:icons}  <div class="rich-text-field-label"><table style="border-collapse: collapse; width: 100.424%; height: 166px; font-size: 110%; margin-left: 0; padding-left: 0;" border="0"> <tbody> <tr style="height: 18px;"> <td style="width: 99.01%; height: 40px; background-color: #ffffe0;" colspan="2">Care Home staff who obtained verbal permission from the residents legal representative: </td> </tr> <tr style="height: 18px;"> <td style="width: 59.505%; height: 41px;">Staff's First name:</td> <td style="width: 39.505%; height: 41px;">{staff_firstname:icons}</td> </tr> <tr style="height: 18px;"> <td style="width: 59.505%; height: 39px;">Staff's Last name:</td> <td style="width: 39.505%; height: 39px;">{staff_lastname:icons}</td> </tr> <tr style="height: 39px;"> <td style="width: 59.505%; height: 39px;">Date verbal permission obtained</td> <td style="width: 39.505%; height: 39px;"> <p>{verbal_date:icons}</p> </td> </tr> </tbody> </table> <p> </p></div> Resident details: <div style="padding:10px 0;background-color: #ffffe0; font-size: 110%;">Resident details:</div> Resident's First name {pt_firstname:icons} Resident's Last name {pt_lastname:icons} Date of Birth: {dob:icons} Age (view only) {age} Gender {gender:icons} <table style="border-collapse: collapse; width: 100%; height: 182px; font-size: 110%;" border="0"> <tbody> <tr style="height: 18px;"> <td style="width: 59.505%; height: 45px;">Resident's First name</td> <td style="width: 39.505%; height: 45px;">{pt_firstname:icons}</td> </tr> <tr style="height: 18px;"> <td style="width: 49.505%; height: 39px;">Resident's Last name</td> <td style="width: 49.505%; height: 39px;">{pt_lastname:icons}</td> </tr> <tr style="height: 18px;"> <td style="width: 49.505%; height: 38px;">Date of Birth:</td> <td style="width: 49.505%; height: 38px;"> <div style="font-size: 85%;">{dob:icons}</div> </td> </tr> <tr style="height: 28px;"> <td style="width: 49.505%; height: 33px;">Age <span style="font-size: 85%;">(view only)</span></td> <td style="width: 49.505%; height: 33px;"> <div style="font-size: 85%;">{age}</div> </td> </tr> <tr style="height: 18px;"> <td style="width: 49.505%; height: 27px;">Gender</td> <td style="width: 49.505%; height: 27px;"> <div style="font-size: 85%; padding-top: 10px;">{gender:icons}</div> </td> </tr> </tbody> </table> pt_initials (hidden) Trial information given to resident by: First Name {brief_firstname:icons} Last Name {brief_lastname:icons} Date trial information given to resident {brief_date:icons}  <div class="rich-text-field-label"><div style="padding-top: 10px; font-size: 110%; background-color: #ffffe0; margin-left: -5px; padding: 5px;">Trial information given to resident by:</div> <table style="margin-top;5px;font-size: 110%; border-collapse: collapse; width: 99.2928%; height: 121px;"> <tbody> <tr style="height: 31px;"> <td style="width: 59.4302%; height: 36px;">First Name</td> <td style="width: 39.5726%; height: 36px;">{brief_firstname:icons}</td> </tr> <tr style="height: 31px;"> <td style="width: 49.4302%; height: 34px;">Last Name</td> <td style="width: 49.5726%; height: 34px;">{brief_lastname:icons}</td> </tr> <tr style="height: 28px;"> <td style="width: 49.4302%; height: 33px;">Date trial information given to resident</td> <td style="width: 49.5726%; height: 33px;"> <div style="font-size: 85%;">{brief_date:icons}</div> </td> </tr> </tbody> </table> <p> </p></div> brief_lastname Date trial information given to resident brief_firstname Staff's First name Staff's Last name: Date verbal permission obtained [ctype] consent form preference<div style="padding-top:10px;font-size:110%;">[ctype] consent form preference</div> Resident's First name Resident's Last name Date of Birth: Age Gender Please complete the Personal Legal Representative details on the next form <div style="padding-top:10px;font-size:110%;">Please complete the Personal Legal Representative details on the next form</div> Date/time of record (read only) ch_name_only (hidden) pt_cons_type (hidden) consultee_cons_type (hidden) Research nurse email address (hidden) Care home email address (hidden) msg1 (hidden) Complete? care home to enter <div class="progress"> <div class="progress-bar" role="progressbar" style="width: 18%" aria-valuenow="18" aria-valuemin="0" aria-valuemax="100">care home to enter</div> </div> [msg2] <div class="progress"> <div class="progress-bar" role="progressbar" style="width: 18%" aria-valuenow="18" aria-valuemin="0" aria-valuemax="100">[msg2]</div> </div> Personal Legal Representative Information First name {consultee_firstname:icons} Last name {consultee_lastname:icons} Mobile number (optional) {consultee_mobile:icons} Home telephone number (optional) {consultee_tel:icons} <div class="rich-text-field-label"><div style="padding: 5px; font-size: 110%; background-color: #ffffe0; margin-left: -5px;">Personal Legal Representative Information</div> <table style="border-collapse: collapse; width: 100%; font-size: 110%;"> <tbody> <tr> <td style="width: 53.2726%;">First name</td> <td style="width: 45.7374%;">{consultee_firstname:icons}</td> </tr> <tr> <td style="width: 53.2726%;">Last name</td> <td style="width: 45.7374%;">{consultee_lastname:icons}</td> </tr> <tr> <td style="width: 53.2726%;">Mobile number <span style="font-size: 80%; font-weight: normal;">(optional)</span></td> <td style="width: 45.7374%;">{consultee_mobile:icons}</td> </tr> <tr> <td style="width: 53.2726%;">Home telephone number <span style="font-size: 80%; font-weight: normal;">(optional)</span></td> <td style="width: 45.7374%;">{consultee_tel:icons}</td> </tr> </tbody> </table></div> Personal legal representatives First name Personal legal representatives Last name Mobile number of personal legal representative Home telephone number of personal legal representative Best time to contact the personal legal representative <div style="font-size: 110%;">Best time to contact the personal legal representative</div> Best time to contact the personal legal representative <div style="font-size: 110%;">Best time to contact the personal legal representative</div> Best time to contact the personal legal representative <div style="font-size: 110%;">Best time to contact the personal legal representative</div> Best time to contact the personal legal representative <div style="font-size: 110%;">Best time to contact the personal legal representative</div> If other, please specify<div style="font-size: 110%;">If other, please specify</div> Personal Legal Representative Email Email address {consultee_email:icons} Re-enter email address {consultee_email2:icons} <div style="padding: 7px 0; font-size: 110%; background-color: #ffffe0;">Personal Legal Representative Email</div> <table style="border-collapse: collapse; width: 100%; font-size: 110%;"> <tbody> <tr > <td style="width: 56.0865%; ">Email address</td> <td style="width: 42.9235%;">{consultee_email:icons}</td> </tr> <tr > <td style="width: 56.0865%;">Re-enter email address</td> <td style="width: 42.9235%;">{consultee_email2:icons}</td> </tr> </tbody> </table> Personal legal representatives email address Re-enter email address Send the information to the residents legal representative and save this form<div style="padding-top:10px;font-size:110%;">Send the information to the residents legal representative and save this form</div> Postal address <div style="padding: 5px; font-size: 120%; background-color: #ffffe0; margin-left: -5px;">Postal address</div> Property name or number<div style="font-size: 110%;">Property name or number</div> Road / Street name<div style="font-size: 110%;">Road / Street name</div> Town / City<div style="font-size: 110%;">Town / City</div> County<div style="font-size: 110%;">County</div> Post code<div style="font-size: 110%;">Post code</div> Entered by NCTU<div style="margin:0;padding-top: 10px; font-size: 110%; background-color: #ffffe0; padding: 5px;">Entered by NCTU</div> The date paper informed consent was sent to the personal legal representative will appear here once posted by NCTU<div style="font-size:110%;margin:5px 0;">The date paper informed consent was sent to the personal legal representative will appear here once posted by NCTU</div> Has the paper informed consent been sent to the legal representative? [cons_paper_sent] <table style="margin: 5px 0;border-collapse: collapse; width: 100%; font-size: 110%;" border="0"> <tbody> <tr> <td style="width: 57.3493%;">Has the paper informed consent been sent to the legal representative?</td> <td style="width: 41.7685%;">[cons_paper_sent]</td> </tr> </tbody> </table> Date paper informed consent form sent  [cons_paper_sentdate] <table style="margin:5px 0;width: 100%; height: 18px; font-size: 110%;" border="0"> <tbody> <tr style="height: 18px;"> <td style="width: 57.4909%; height: 18px;">Date paper informed consent form sent </td> <td style="width: 41.6269%; height: 18px;">[cons_paper_sentdate]</td> </tr> </tbody> </table> Please provide details if not sent [nsent_reas] <table style="margin:5px 0;border-collapse: collapse; width: 100%; height: 17px;font-size:110%;" border="0"> <tbody> <tr style="height: 17px;"> <td style="width: 49.5589%; height: 17px;" colspan="2" rowspan="2">Please provide details if not sent<br />[nsent_reas]</td> </tr> <tr></tr> </tbody> </table> Entered details date (hidden only) display nctu enter PLR form (hidden) msg2 (hidden) Complete? Has the paper informed consent been sent to the legal representative? Date paper informed consent form sent Please provide details if not sent Complete? RN to enter <div class="progress"> <div class="progress-bar" role="progressbar" style="width: 27%" aria-valuenow="27" aria-valuemin="0" aria-valuemax="100">RN to enter</div> </div> [msg3] <div class="progress"> <div class="progress-bar" role="progressbar" style="width: 27%" aria-valuenow="27" aria-valuemin="0" aria-valuemax="100">[msg3]</div> </div> Online information is not sent to Personal Legal Representative. <div style="color:red;font-size:110%;">Online information is not sent to Personal Legal Representative. </div> Paper information has not yet been sent to Personal Legal Representative by NCTU <div style="color:red;font-size:110%;">Paper information has not yet been sent to Personal Legal Representative by NCTU</div> Video call has been completed. Please don't save this form and close it. <div style="color:green;font-size:110%;">Video call has been completed. <span style="color:red;">Please don't save this form and close it.</span></div> Care home telephone number (read only) Scheduled Appointment Date and Time Once the scheduled appointment date and time is entered please save the form. Please return to complete the rest of the form once the call has been made. An appointment has been scheduled by research nurse, please wait. Version of information sheet provided: Is resident/PLR ready to proceed to complete the consent form? Is <span id="res_plr">resident/PLR</span> ready to proceed to complete the consent form? Once resident is ready to complete consent form click "Yes" above and save the form. Care home staff should then open the  Consent Administration Form to access the consent form for the resident to complete. Once resident is ready to complete consent form click "Yes" above and save the form. Care home staff should then open the <a href="../DataEntry/index.php?pid=[project-id]&page=consent_form_administration&id=[record-name]&event_name=[event-name]"> Consent Administration Form</a> to access the consent form for the resident to complete. vd_drv (hidden) appo_date_drv (hidden) Send the consent form link to resident's legal representative (tick the box and save the form and consent link will be emailed automatically) <div style="padding-top:10px;font-size:100%;">Send the consent form link to resident's legal representative (tick the box and save the form and consent link will be emailed automatically) </div> Please provide details if selected no compare time (hidden) Appointment state (hidden) If the scheduled appointment is not completed and an additional appointment needs to be scheduled, please click "Save & Add New Instance" to enter new appointment details. cap_drv to use in javascript to change resident/PLR to resident or PLR (hidden) msg3 (hidden) Complete? resident to enter <div class="progress"> <div class="progress-bar" role="progressbar" style="width: 36%" aria-valuenow="36" aria-valuemin="0" aria-valuemax="100">resident to enter</div> </div> NCTU to upload <div class="progress"> <div class="progress-bar" role="progressbar" style="width: 36%" aria-valuenow="36" aria-valuemin="0" aria-valuemax="100">NCTU to upload</div> </div> [msg5] <div class="progress"> <div class="progress-bar" role="progressbar" style="width: 36%" aria-valuenow="36" aria-valuemin="0" aria-valuemax="100">[msg5]</div> </div> pis_version_drv (hidden) pis_ver (hidden) pis_ver_date (hidden) Prophylactic Therapy in Care Homes Trial (PROTECT-CH) Informed Consent Form [pis_ver], [pis_ver_date]   IRAS Project ID: 294832 Participant's name:  [pt_firstname] [pt_lastname] Participant Study ID  [pat_id] <div class="rich-text-field-label"><center> <div style="font-size: 110%;">Prophylactic Therapy in Care Homes Trial (PROTECT-CH) <br />Informed Consent Form</div> <div style="font-size: 70%;">[pis_ver], [pis_ver_date]</div> </center> <p> </p> <table style="border-collapse: collapse; width: 100%; height: 68px;" border="0"> <tbody> <tr style="height: 18px;"> <td style="width: 28.6594%; height: 18px;">IRAS Project ID:</td> <td style="width: 70.3261%; height: 18px;">294832</td> </tr> <tr style="height: 36px;"> <td style="width: 28.6594%; height: 33px;">Participant's name: </td> <td style="width: 70.3261%; height: 33px; font-size: 110%; color: blue;"><strong>[pt_firstname] [pt_lastname]</strong></td> </tr> <tr> <td style="width: 28.6594%;">Participant Study ID</td> <td style="width: 70.3261%; font-size: 110%; color: blue;"><strong> [pat_id]</strong></td> </tr> </tbody> </table></div> Tick the box if participant is not able to read the text and/or sign for themselves but has capacity to give consent I confirm that my care home and the research team have discussed the PROTECT-CH trial with me and given me the Participant Information Sheet dated: [pis_ver_date], version: [pis_ver], which I have read and understood. I have had the opportunity to consider the information, ask questions and have had these answered satisfactorily. I understand that taking part is voluntary and that I can withdraw at any time, without giving any reason. My medical care or legal rights will not be affected. I understand that if I withdraw, the information collected so far cannot be deleted and may still be used in the trial. I understand that if my care home is allocated to give usual care or my care home is allocated to give a trial medication that I cannot take I will not receive the trial medication. I will continue receiving my usual care. I agree to my GP being informed of my participation in this trial. I agree to the research team contacting my GP for further information regarding my medical history and current medications. I understand that relevant sections of my medical notes and data collected in the trial may be looked at by authorised individuals from the Nottingham Clinical Trials Unit (NCTU), the Sponsor (University of Nottingham), central NHS bodies, trusted third parties, the research team and regulatory authorities where it is relevant to my taking part in this trial. I give permission for these individuals to have access to my records and for the NCTU to have a copy of my signed consent form. I give permission for the NCTU, the Sponsor, trusted third parties and the research team to collect, collate, store, analyse and publish information obtained from my participation in this trial. I understand that my personal details will be kept confidential. I understand that all information and personal data relevant to the trial will be shared with, stored and maintained by my care home, GP, trusted third parties, NHS Digital and other central UK NHS bodies in order to help contact me or provide information about my health status. I understand that the anonymised information collected about me may be used to support other research in the future and may be shared with other researchers. I agree that my legal representative can discuss my ongoing involvement in the trial, should I lose capacity to make this decision for myself during the trial. I agree to take part in the above trial. Optional consent: <div style="font-size:110%;">Optional consent: </div> I agree to be approached about taking further medications or other treatments as part of this trial in the future. I am happy to be contacted about taking part in an interview to talk about my experience of taking part in this trial. Name of Participant Signature Date ptname_correct (hidden) I witnessed accurate reading of the consent form to the potential participant, who could ask any questions and got satisfactory replies. I confirm that they gave their consent freely.<div class="rich-text-field-label"><p>I witnessed accurate reading of the consent form to the potential participant, who could ask any questions and got satisfactory replies.</p> <p>I confirm that they gave their consent freely.</p></div> Name of Witness Signature Date For NCTU Upload Paper Consent<div class="rich-text-field-label"><div style="padding-top: 10px; font-size: 110%; background-color: #ffffe0; margin-left: -5px; padding: 5px;">For NCTU Upload Paper Consent</div></div> Please upload the completed participant paper informed consent Date of the uploaded the participant paper informed consent file Remember to upload the paper consent in [eligibility_arm_1][form-link:gp_confirmation_of_eligibility:GP Confirmation Of Eligibility] GP eligibility form 'Resident signed consent' field <div class="alert alert-danger" role="alert">Remember to upload the paper consent in [eligibility_arm_1][form-link:gp_confirmation_of_eligibility:GP Confirmation Of Eligibility] GP eligibility form 'Resident signed consent' field</div> For Research Nurse Countersign<div style="padding-top: 10px; font-size: 110%; background-color: purple; margin-left: -5px; padding: 5px;color:white;">For Research Nurse Countersign</div> Please click 'Edit response' at the top of page before countersign. <div style="padding:5px 0;">Please click 'Edit response' at the top of page before countersign.</div> Name of person taking consent (You must be on the delegation log)<p>Name of person taking consent<br /><span style="font-size: 90%;">(You must be on the delegation log)</span></p> Signature Date rn_pt_cosign (hidden) msg5 (hidden) Complete? PLR to enter <div class="progress"> <div class="progress-bar" role="progressbar" style="width: 45%" aria-valuenow="45" aria-valuemin="0" aria-valuemax="100">PLR to enter</div> </div> NCTU to upload <div class="progress"> <div class="progress-bar" role="progressbar" style="width: 45%" aria-valuenow="45" aria-valuemin="0" aria-valuemax="100">NCTU to upload</div> </div> [msg6] <div class="progress"> <div class="progress-bar" role="progressbar" style="width: 45%" aria-valuenow="45" aria-valuemin="0" aria-valuemax="100">[msg6]</div> </div> plr_pis_version_drv (hidden) plr_pis_ver (hidden) plr_pis_ver_date (hidden) Prophylactic Therapy in Care Homes Trial (PROTECT-CH) Legal Representative Informed Consent Form [plr_pis_ver], [plr_pis_ver_date]   IRAS Project ID: 294832 Participant's name:  [pt_firstname] [pt_lastname] Participant Study ID: [pat_id] <div class="rich-text-field-label"><center> <div style="font-size: 110%;">Prophylactic Therapy in Care Homes Trial (PROTECT-CH) <br />Legal Representative Informed Consent Form</div> <div style="font-size: 70%;">[plr_pis_ver], [plr_pis_ver_date]</div> </center> <p> </p> <table style="border-collapse: collapse; width: 100%; height: 68px;" border="0"> <tbody> <tr style="height: 18px;"> <td style="width: 21.5873%; height: 18px;">IRAS Project ID:</td> <td style="width: 77.3982%; height: 18px;">294832</td> </tr> <tr style="height: 36px;"> <td style="width: 21.5873%; height: 33px;">Participant's name: </td> <td style="width: 77.3982%; height: 33px; font-size: 110%; color: blue;"><strong>[pt_firstname] [pt_lastname]</strong></td> </tr> <tr> <td style="width: 21.5873%;">Participant Study ID:</td> <td style="width: 77.3982%; font-size: 110%; color: blue;"><strong>[pat_id]</strong></td> </tr> </tbody> </table></div> I confirm that the care home and the research team have discussed the PROTECT-CH trial with me and given me the Legal Representative Information Sheet dated: [plr_pis_ver_date], version: [plr_pis_ver], which I have read and understood. I have had the opportunity to consider the information, ask questions and have had these answered satisfactorily. I understand that taking part is voluntary for the person I am representing and that I can request they are withdrawn at any time, without giving any reason. Their medical care or legal rights will not be affected. I understand that if I withdraw them, the information collected so far cannot be deleted and may still be used in the trial. I understand that if the care home of the person I am representing is allocated to give usual care or the care home is allocated to give a trial medication that the person I am representing cannot take, they will not receive the trial medication. They will continue receiving their usual care. I agree to questionnaires being completed about the health of the person I am representing during the trial whether they are allocated to usual care or usual care plus medication. I agree to the GP of the person I am representing being informed of their participation in this trial. I agree to the research team contacting their GP for further information regarding their medical history and current medications. I understand that relevant sections of the medical notes of the person I am representing and data collected in the trial may be looked at by authorised individuals from the Nottingham Clinical Trials Unit (NCTU), the Sponsor (University of Nottingham), central NHS bodies, trusted third parties, the research team and regulatory authorities where it is relevant to them taking part in this trial. I give permission for these individuals to have access to the records of the person I am representing and for the NCTU to have a copy of this signed Consent Form. I give permission for the NCTU, the Sponsor, trusted third parties and the research team to collect, store, analyse and publish information obtained from participation in this trial by the person I am representing. I understand that their personal details will be kept confidential. I understand that all information and personal data relevant to the trial will be shared with, stored and maintained by the care home, GP, trusted third parties, NHS Digital and other central UK NHS bodies in order to help contact the person I am representing or provide information about their health status. I understand that the anonymised information collected about the person I am representing may be used to support other research in the future and may be shared with other researchers. I give permission for the NCTU, the Sponsor and the research team to collect and store my contact details to discuss trial treatment options with me for the person I am representing. I understand my personal details will be kept confidential. In my opinion, the person I am representing would have no objection to taking part in the above trial. Optional consent: <div style="font-size:110%;">Optional consent: </div> I agree to be approached about the person I am representing taking further medications or other treatments as part of this trial in the future. I am happy to be contacted about taking part in an interview to talk about my experience of taking part in this trial. I confirm I am the Legal Representative for the participant named above. Relationship to participant Name of Legal Representative Signature Date consultee_correct (hidden) For NCTU Upload Paper Consent<div style="padding-top: 10px; font-size: 110%; background-color: #ffffe0; margin-left: -5px; padding: 5px;">For NCTU Upload Paper Consent</div> Please upload the completed personal legal representative paper informed consent Date the paper PLR ICF was uploaded Remember to upload the paper consent in [eligibility_arm_1][form-link:gp_confirmation_of_eligibility:GP Confirmation Of Eligibility] 'Personal legal representatives signed consent' field after you have done this form <div class="alert alert-danger" role="alert">Remember to upload the paper consent in [eligibility_arm_1][form-link:gp_confirmation_of_eligibility:GP Confirmation Of Eligibility] 'Personal legal representatives signed consent' field after you have done this form</div> For Research Nurse Countersign <div style="padding-top: 10px; font-size: 110%; background-color:purple; color:white; margin-left: -5px; padding: 5px;">For Research Nurse Countersign </div> Please click 'Edit response' at the top of page before countersign. <div style="padding:5px 0;">Please click 'Edit response' at the top of page before countersign.</div> Name of person taking consent (You must be on the delegation log) Name of person taking consent <span style="font-size:90%;">(You must be on the delegation log)</span> Signature Date rn_consultee_cosign (hidden) msg6 (hidden) Complete? care home to enter <div class="progress"> <div class="progress-bar" role="progressbar" style="width: 54%" aria-valuenow="54" aria-valuemin="0" aria-valuemax="100">care home to enter</div> </div> completed <div class="progress"> <div class="progress-bar" role="progressbar" style="width: 54%" aria-valuenow="54" aria-valuemin="0" aria-valuemax="100">completed</div> </div> MOBILITY SELF-CARE USUAL ACTIVITIES (e.g. work, study, housework, family or leisure activities)USUAL ACTIVITIES<em> (e.g. work, study, housework, family or leisure activities)</em> PAIN / DISCOMFORT ANXIETY / DEPRESSION We would like to know how good or bad their health is TODAY. This scale is numbered from 0 to 100. 100 means the best health you can imagine. 0 means the worst health you can imagine. Please click on the scale to indicate how their health is TODAY. <ul> <li>We would like to know how good or bad their health is <span style="color:#c00">TODAY</span>.</li> <li>This scale is numbered from 0 to 100. </li> <li>100 means the <u>best</u> health you can imagine. 0 means the <u>worst</u> health you can imagine.</li> <li>Please click on the scale to indicate how their health is TODAY.</li> </ul> <i> Complete? Does the resident have capacity? Please ensure that the resident completes the self-reported EQ5D5L, this can be accessed at the below link. [survey-link:eq5d5l:Quality of life (EQ5D5L)] You may assist the resident in completing the survey, however the responses given should be their own. Once completed, please save and close this form. Complete? resident to enter <div class="progress"> <div class="progress-bar" role="progressbar" style="width: 63%" aria-valuenow="73" aria-valuemin="0" aria-valuemax="100">resident to enter</div> </div> completed <div class="progress"> <div class="progress-bar" role="progressbar" style="width: 63%" aria-valuenow="73" aria-valuemin="0" aria-valuemax="100">completed</div> </div> Care home staff has to complete [survey-link:eq5d5l_proxy:Quality of life (EQ5D5L Proxy) questions]. Please close the form. <div style="color:red;">Care home staff has to complete [survey-link:eq5d5l_proxy:Quality of life (EQ5D5L Proxy) questions]. Please close the form. </div> Redirect Page EQ5DL Event ID (HIDDEN) MOBILITY SELF-CARE USUAL ACTIVITIES (e.g. work, study, housework, family or leisure activities)USUAL ACTIVITIES<em> (e.g. work, study, housework, family or leisure activities)</em> PAIN / DISCOMFORT ANXIETY / DEPRESSION We would like to know how good or bad your health is TODAY. This scale is numbered from 0 to 100. 100 means the best health you can imagine. 0 means the worst health you can imagine. Please click on the scale to indicate how your health is TODAY. <ul> <li>We would like to know how good or bad your health is <span style="color:#c00">TODAY</span>.</li> <li>This scale is numbered from 0 to 100. </li> <li>100 means the <u>best</u> health you can imagine. 0 means the <u>worst</u> health you can imagine.</li> <li>Please click on the scale to indicate how your health is TODAY.</li> </ul> Complete? care home to enter <div class="progress"> <div class="progress-bar" role="progressbar" style="width: 72%" aria-valuenow="72" aria-valuemin="0" aria-valuemax="100">care home to enter</div> </div> completed <div class="progress"> <div class="progress-bar" role="progressbar" style="width: 72%" aria-valuenow="72" aria-valuemin="0" aria-valuemax="100">completed</div> </div> Consent appointment is not completed. <div style="color:red;font-size:110%;">Consent appointment is not completed.</div> For Care Home with Resident Online Consent   This form will guide you through the next steps once the research nurse has scheduled a consent appointment with the resident.  Please follow the steps below.  <div class="rich-text-field-label"><div style="font-size: 110%; background-color: #ffffe0; color: purple; padding: 10px 0;">For Care Home with Resident Online Consent</div> <div style="font-size: 110%;"> </div> <div style="font-size: 110%;">This form will guide you through the next steps once the research nurse has scheduled a consent appointment with the resident.  Please follow the steps below.</div> <div> </div></div> Is the resident paper consent complete? <div style="font-size:110%;">Is the resident paper consent complete?</div> Date resident's paper consent completed <div style="font-size:110%;">Date resident's paper consent completed</div>   Please ensure the completed paper consent form is sent to Nottingham Clinical Trials Unit (NCTU) in the pre-paid envelope provided. NCTU will upload the completed consent form onto the database. The research nurse will then countersign.  <div class="rich-text-field-label"><p> </p> <div style="color: red; font-size: 110%;">Please ensure the completed paper consent form is sent to Nottingham Clinical Trials Unit (NCTU) in the pre-paid envelope provided. NCTU will upload the completed consent form onto the database. The research nurse will then countersign.</div> <p> </p></div>   1. Please click link below to complete resident consent form after the appointment [survey-link:consent_form_resident_with_capacity:Consent Form]   After the resident has completed the online consent please click here to refresh this form.  <div class="rich-text-field-label"><p> </p> <div style="font-size: 110%;">1. Please click link below to complete resident consent form after the appointment<br /> <div style="margin-left: 15px;">[survey-link:consent_form_resident_with_capacity:Consent Form]</div> <div style="margin-left: 15px;"> </div> <div style="margin-left: 15px;">After the resident has completed the online consent please click <a href="../DataEntry/index.php?pid=[project-id]&page=consent_form_administration&id=[record-name]&event_name=consent_arm_1">here</a> to refresh this form. </div> </div></div> 1. Resident has completed online consent form <div style="font-size:110%;color:green;">1. Resident has completed online consent form</div>   Please wait for research nurse to countersign the resident's completed consent form.  <div class="rich-text-field-label"><p> </p> <div style="font-size: 110%;">Please wait for research nurse to countersign the resident's completed consent form.</div> <p> </p></div> 2. Care Home staff please click and complete Quality of life (EQ5D5L) questions <div style="font-size:110%;">2. Care Home staff please click and complete <a href=" [survey-url:eq5d5l_proxy] ">Quality of life (EQ5D5L) questions</a> </div> 2. Care Home staff please click and complete Quality of life (EQ5D5L) questions <div style="font-size:110%;">2. Care Home staff please click and complete Quality of life (EQ5D5L) questions</div> 2. Care Home staff completed Quality of life (EQ5D5L Proxy) questions <div style="font-size:110%;color:green;">2. Care Home staff completed Quality of life (EQ5D5L Proxy) questions</div> 3. Please ensure that the resident completes the self-reported EQ5D5L, this can be accessed at the below link. Quality of life (EQ5D5L) You may assist the resident in completing the survey, however the responses given should be their own. <div style="font-size:110%;">3. Please ensure that the resident completes the self-reported EQ5D5L, this can be accessed at the below link. <a href="[survey-url:eq5d5l]">Quality of life (EQ5D5L)</a> You may assist the resident in completing the survey, however the responses given should be their own. </div> 3. Please ensure that the resident completes the self-reported EQ5D5L, this can be accessed at the below link. Quality of life (EQ5D5L) You may assist the resident in completing the survey, however the responses given should be their own. <div style="font-size:110%;">3. Please ensure that the resident completes the self-reported EQ5D5L, this can be accessed at the below link. Quality of life (EQ5D5L) You may assist the resident in completing the survey, however the responses given should be their own. </div> 3. Resident completed Quality of life (EQ5D5L) <div style="font-size:110%;color:green;">3. Resident completed Quality of life (EQ5D5L)</div> For Care Home with Resident Paper Consent This form will guide you through the next steps once the research nurse has countersigned resident's paper consent. Please follow 2 steps that is displayed each time.  <div class="rich-text-field-label"><div style="font-size: 110%; background-color: #ffffe0; color: purple; padding: 10px 0;">For Care Home with Resident Paper Consent</div> <div style="font-size: 110%;">This form will guide you through the next steps once the research nurse has countersigned resident's paper consent. Please follow 2 steps that is displayed each time.</div> <p> </p></div> 1. Care Home staff please click and complete [survey-link:eq5d5l_proxy:Quality of life (EQ5D5L) questions] <div style="font-size:110%;">1. Care Home staff please click and complete [survey-link:eq5d5l_proxy:Quality of life (EQ5D5L) questions] </div> 1. Care Home staff please click and complete Quality of life (EQ5D5L) questions <div style="font-size:110%;">1. Care Home staff please click and complete Quality of life (EQ5D5L) questions</div> 1. Care Home staff completed Quality of life (EQ5D5L Proxy) questions <div style="font-size:110%;color:green;">1. Care Home staff completed Quality of life (EQ5D5L Proxy) questions</div> 2. Please ensure that the resident completes the self-reported EQ5D5L, this can be accessed at the below link. Quality of life (EQ5D5L) You may assist the resident in completing the survey, however the responses given should be their own. <div style="font-size:110%;">2. Please ensure that the resident completes the self-reported EQ5D5L, this can be accessed at the below link. <a href="[survey-url:eq5d5l]">Quality of life (EQ5D5L)</a> You may assist the resident in completing the survey, however the responses given should be their own. </div> 2. Please ensure that the resident completes the self-reported EQ5D5L, this can be accessed at the below link. Quality of life (EQ5D5L) You may assist the resident in completing the survey, however the responses given should be their own. <div style="font-size:110%;">2. Please ensure that the resident completes the self-reported EQ5D5L, this can be accessed at the below link. Quality of life (EQ5D5L) You may assist the resident in completing the survey, however the responses given should be their own. </div> 2. Resident completed Quality of life (EQ5D5L) <div style="font-size:110%;color:green;">2. Resident completed Quality of life (EQ5D5L)</div> Consent Form Administration is completed <div style="font-size:110%;color:purple;text-align:center;">Consent Form Administration is completed</div> Complete? care home to enter <div class="progress"> <div class="progress-bar" role="progressbar" style="width: 81%" aria-valuenow="81" aria-valuemin="0" aria-valuemax="100">care home to enter </div> </div> completed <div class="progress"> <div class="progress-bar" role="progressbar" style="width: 81%" aria-valuenow="81" aria-valuemin="0" aria-valuemax="100">completed </div> </div> Ethnicity Weight (kg) 35 The value you provided is outside the suggested range. (35 - 150). This value is admissible, but you may wish to double check it. 150 The value you provided is outside the suggested range. (35 - 150). This value is admissible, but you may wish to double check it. Is the residents height known or can it be measured ? Height (cm) 120 The value you provided is outside the suggested range. (120 - 220). This value is admissible, but you may wish to double check it. 220 The value you provided is outside the suggested range. (120 - 220). This value is admissible, but you may wish to double check it. Measure demi-span (cm) 60 The value you provided is outside the suggested range. (60 - 110). This value is admissible, but you may wish to double check it. 110 The value you provided is outside the suggested range. (60 - 110). This value is admissible, but you may wish to double check it. Height (cm) (read only) BMI (hidden) Smoking status Date resident moved into the care home Does the resident currently have an Advance Care Plan/Directive saying that they do not want to be admitted to hospital? Does the resident currently have a Do Not Attempt Resuscitation (DNAR) order? msg9 (hidden) Complete? care home to enter <div class="progress"> <div class="progress-bar" role="progressbar" style="width: 90%" aria-valuenow="90" aria-valuemin="0" aria-valuemax="100">care home to enter</div> </div> completed <div class="progress"> <div class="progress-bar" role="progressbar" style="width: 90%" aria-valuenow="90" aria-valuemin="0" aria-valuemax="100">completed</div> </div> Exclusion criteria<div style="padding: 7px 0; font-size: 110%; color: #800000; text-align: center; background-color: #ffffe0;">Exclusion criteria</div> In another COVID-19 prevention or treatment trial <div style="font-size:110%">In another COVID-19 prevention or treatment trial</div> Identified by care home staff to have entered end-stage palliative care. <div style="font-size:110%">Identified by care home staff to have entered end-stage palliative care.</div> Resident in care home for short-term respite care. <div style="font-size:110%">Resident in care home for short-term respite care.</div> ch_elig_score (hidden) Eligibility - Yes <div style="font-size:110%;text-align:center;;color:white;background-color:purple;"> Eligibility - Yes </div> Eligibility - No <div style="font-size:110%;text-align:center;;color:white;background-color:purple;"> Eligibility - No </div> msg10 (hidden) Complete? care home to enter <div class="progress"> <div class="progress-bar" role="progressbar" style="width: 100%" aria-valuenow="100" aria-valuemin="0" aria-valuemax="100">care home to enter</div> </div> completed <div class="progress"> <div class="progress-bar" role="progressbar" style="width: 100%" aria-valuenow="100" aria-valuemin="0" aria-valuemax="100">completed</div> </div> NHS / CHI Number: <div style="padding-top:10px;font-size:120%;">NHS / CHI Number: </div> Practice Name:<div style="padding-top:10px;font-size:120%;">Practice Name:</div> Practice Telephone Number<div style="padding-top:10px;font-size:120%;">Practice Telephone Number</div> GP Practice Email Address <div style="padding-top:10px;font-size:120%;">GP Practice Email Address </div> Once this form is completed and saved, please complete the Vaccination Status form. [vaccination_arm_1][form-link:vaccination_status] <div style="padding-top:10px;font-size:120%;">Once this form is completed and saved, please complete the Vaccination Status form. [vaccination_arm_1][form-link:vaccination_status] </div> practice_name to show in report (data get it from Javascript) (hidden) Eligibility Survey Link [eligibility_arm_1][survey-url:gp_confirmation_of_eligibility:Eligibility Form] (hidden) msg11 (hidden) Complete? consent stage completed <div class="progress"> <div class="progress-bar" role="progressbar" style="width: 100%;text-align:centre;" aria-valuenow="100" aria-valuemin="0" aria-valuemax="100">consent stage completed</div> </div> Did Resident have capacity when consent obtained? [capacity] <div style="font-size:110%">Did Resident have capacity when consent obtained? <span style="color:blue;">[capacity]</span> </div> Does the resident have capacity to give consent? <div style="font-size:110%">Does the resident have capacity to give consent? </div> Is the original PLR changing to a new individual? <div style="font-size:110%">Is the original PLR changing to a new individual? </div> Date of PLR change: (may delete it) <div style="font-size:110%">Date of PLR change:</div> (may delete it) Has the resident's legal representative given their verbal permission for the PROTECT-CH trial team to use their contact details? <div style="font-size:110%">Has the resident's legal representative given their verbal permission for the PROTECT-CH trial team to use their contact details?</div> Care Home staff who obtained verbal permission from the residents legal representative:  Staff's First name: {staff_firstname2:icons} Staff's Last name: {staff_lastname2:icons} Date verbal permission obtained {verbal_date2:icons} <div class="rich-text-field-label"><table style="border-collapse: collapse; width: 100.424%; height: 166px; font-size: 110%; margin-left: 0; padding-left: 0;" border="0"> <tbody> <tr style="height: 18px;"> <td style="width: 99.01%; height: 40px; background-color: #ffffe0; font-size: 90%;" colspan="2">Care Home staff who obtained verbal permission from the residents legal representative: </td> </tr> <tr style="height: 18px;"> <td style="width: 57.8125%; height: 41px;">Staff's First name:</td> <td style="width: 41.1975%; height: 41px;">{staff_firstname2:icons}</td> </tr> <tr style="height: 18px;"> <td style="width: 57.8125%; height: 39px;">Staff's Last name:</td> <td style="width: 41.1975%; height: 39px;">{staff_lastname2:icons}</td> </tr> <tr style="height: 39px;"> <td style="width: 57.8125%; height: 39px;">Date verbal permission obtained</td> <td style="width: 41.1975%; height: 39px;"> <p>{verbal_date2:icons}</p> </td> </tr> </tbody> </table></div> Staff's First name Staff's Last name: Date verbal permission obtained recap_date (hidden) Personal Legal Representative contact preference <div style="padding-top:10px;font-size:110%;">Personal Legal Representative contact preference</div> Personal Legal Representative Information First name {consultee_firstname2:icons} Last name {consultee_lastname2:icons} Mobile number (optional) {consultee_mobile2:icons} Home telephone number (optional) {consultee_tel2:icons} <div class="rich-text-field-label"><div style="padding: 5px; font-size: 110%; background-color: #ffffe0; margin-left: -5px;">Personal Legal Representative Information</div> <table style="border-collapse: collapse; width: 100%; font-size: 110%;"> <tbody> <tr> <td style="width: 57.3803%;">First name</td> <td style="width: 41.6297%;">{consultee_firstname2:icons}</td> </tr> <tr> <td style="width: 57.3803%;">Last name</td> <td style="width: 41.6297%;">{consultee_lastname2:icons}</td> </tr> <tr> <td style="width: 57.3803%;">Mobile number <span style="font-size: 80%; font-weight: normal;">(optional)</span></td> <td style="width: 41.6297%;">{consultee_mobile2:icons}</td> </tr> <tr> <td style="width: 57.3803%;">Home telephone number <span style="font-size: 80%; font-weight: normal;">(optional)</span></td> <td style="width: 41.6297%;">{consultee_tel2:icons}</td> </tr> </tbody> </table></div> Personal legal representatives First name Personal legal representatives Last name Mobile number of personal legal representative Home telephone number of personal legal representative Best time to contact the personal legal representative <div style="font-size: 110%;">Best time to contact the personal legal representative</div> Best time to contact the personal legal representative <div style="font-size: 110%;">Best time to contact the personal legal representative</div> Best time to contact the personal legal representative <div style="font-size: 110%;">Best time to contact the personal legal representative</div> Best time to contact the personal legal representative <div style="font-size: 110%;">Best time to contact the personal legal representative</div> If other, please specify<div style="font-size: 110%;">If other, please specify</div> Personal Legal Representative Email Email address {consultee_email_new:icons} Re-enter email address {consultee_email_new2:icons} <div class="rich-text-field-label"><div style="padding: 7px 0; font-size: 110%; background-color: #ffffe0;">Personal Legal Representative Email</div> <table style="border-collapse: collapse; width: 100%; font-size: 110%;"> <tbody> <tr> <td style="width: 57.6446%;">Email address</td> <td style="width: 41.3654%;">{consultee_email_new:icons}</td> </tr> <tr> <td style="width: 57.6446%;">Re-enter email address</td> <td style="width: 41.3654%;">{consultee_email_new2:icons}</td> </tr> </tbody> </table></div> Personal legal representatives email address Re-enter email address Send the information to the residents legal representative and save this form<div style="padding-top:10px;font-size:110%;">Send the information to the residents legal representative and save this form</div> Postal address<div style="padding: 5px; font-size: 120%; background-color: #ffffe0; margin-left: -5px;">Postal address</div> Property name or number<div style="font-size:110%;">Property name or number</div> Road / Street name<div style="font-size:110%;">Road / Street name</div> Town / City<div style="font-size:110%;">Town / City</div> County<div style="font-size:110%;">County</div> Post code<div style="font-size:110%;">Post code</div> Entered by NCTU<div style="margin:0;padding-top: 10px; font-size: 110%; background-color: #ffffe0; padding: 5px;">Entered by NCTU</div> The date paper informed consent was sent to the personal legal representative will appear here once posted by NCTU<div style="font-size:110%;margin:5px 0;">The date paper informed consent was sent to the personal legal representative will appear here once posted by NCTU</div> Has the paper informed consent been sent to the legal representative? [cons_paper_sent2] <table style="margin: 5px 0;border-collapse: collapse; width: 100%; font-size: 110%;" border="0"> <tbody> <tr> <td style="width: 57.3493%;">Has the paper informed consent been sent to the legal representative?</td> <td style="width: 41.7685%;">[cons_paper_sent2]</td> </tr> </tbody> </table> Date paper informed consent form sent  [cons_paper_sentdate2] <div class="rich-text-field-label"><table style="margin: 5px 0; width: 100%; height: 18px; font-size: 110%;" border="0"> <tbody> <tr style="height: 18px;"> <td style="width: 57.4909%; height: 18px;">Date paper informed consent form sent </td> <td style="width: 41.6269%; height: 18px;">[cons_paper_sentdate2]</td> </tr> </tbody> </table></div> Please provide details if not sent [nsent_reas2] <table style="margin: 5px 0; border-collapse: collapse; width: 100%; height: 17px; font-size: 110%;" border="0"> <tbody> <tr style="height: 17px;"> <td style="height: 17px; width: 57.8499%;">Please provide details if not sent<br /><br /></td> <td style="width: 42.0086%;">[nsent_reas2]</td> </tr> </tbody> </table> For NCTU to enter only Has the paper trial information been sent to the legal representative? {cons_paper_sent2:icons} Date paper informed consent form sent {cons_paper_sentdate2:icons} <div class="rich-text-field-label"><div style="padding-top: 10px; font-size: 110%; background-color: #ffffe0; padding: 5px;">For NCTU to enter only</div> <table style="border-collapse: collapse; width: 100%; height: 107px;"> <tbody> <tr style="height: 60px;"> <td style="width: 62.2989%; height: 60px;">Has the paper trial information been sent to the legal representative?</td> <td style="width: 36.8031%; height: 60px;">{cons_paper_sent2:icons}</td> </tr> <tr style="height: 47px;"> <td style="width: 62.2989%; height: 47px;">Date paper informed consent form sent</td> <td style="width: 36.8031%; height: 47px; font-size: 90%;">{cons_paper_sentdate2:icons}</td> </tr> </tbody> </table></div> Has the paper informed consent form been sent to the legal representative? Date paper trial information sent Please provide details first_plr Complete? Vaccination History Received Vaccination 60 Days from Rand (Hidden) Received Vaccination Which vaccine? Please specify the type of vaccination How was vaccination administered? Name of vaccine Name of vaccine If other, please specify Date of vaccination 2020-12-01 The value you provided is outside the suggested range. (2020-12-01 - no limit). This value is admissible, but you may wish to double check it. vac_pi_history (hidden) Complete? PROTECT-CH GP Eligibility Assessment Participant's name [consent_arm_1][pt_firstname] [consent_arm_1][pt_lastname] Participant's trial ID [record-name] Resident's NHS/CHI Number [consent_arm_1][nhs_no] Care Home Name [record-dag-label] Practice Name [consent_arm_1][gp_practice] <div class="rich-text-field-label"><div style="font-size: 130%;"><center>PROTECT-CH GP Eligibility Assessment</center></div> <table style="font-size: 110%; border-collapse: collapse; width: 100%; height: 75px; margin: 10px 0;"> <tbody> <tr style="height: 20px;"> <td style="width: 31.7442%; height: 10px;">Participant's name</td> <td style="width: 67.2413%; height: 10px; color: blue;"><strong>[consent_arm_1][pt_firstname] [consent_arm_1][pt_lastname]</strong></td> </tr> <tr style="height: 20px;"> <td style="width: 31.7442%; height: 21px;">Participant's trial ID</td> <td style="color: blue; width: 67.2413%; height: 21px;"><strong>[record-name]</strong></td> </tr> <tr style="height: 20px;"> <td style="width: 31.7442%; height: 18px;">Resident's NHS/CHI Number</td> <td style="width: 67.2413%; height: 18px; color: blue;"><strong>[consent_arm_1][nhs_no]</strong></td> </tr> <tr style="height: 20px;"> <td style="width: 31.7442%; height: 26px;">Care Home Name</td> <td style="width: 67.2413%; height: 26px; color: blue;">[record-dag-label]</td> </tr> <tr> <td style="width: 31.7442%;">Practice Name</td> <td style="width: 67.2413%; color: blue;"><strong>[consent_arm_1][gp_practice]</strong></td> </tr> </tbody> </table></div> Resident paper signed consent Resident countersigned consent: Click to download <table style="border-collapse: collapse; width: 100%; margin: 10px 0;"> <tbody> <tr> <td style="width: 57.6247%;">Resident countersigned consent:</td> <td style="width: 41.4773%;">Click <a href="https://redcap01.nottingham.ac.uk/redcap_v10.6.11/index.php?route=PdfController:index&pid=[project-id]&s=&page=consent_form_resident_with_capacity&id=[record-name]&event_id=143"><img src="/redcap_v10.6.11/Resources/images/pdf.gif" alt="" /></a> to download</td> </tr> </tbody> </table> Personal legal representatives paper signed consent: Personal legal representatives countersigned consent: Click to download <table style="border-collapse: collapse; width: 100%; margin: 10px 0;"> <tbody> <tr> <td style="width: 57.6247%;">Personal legal representatives countersigned consent:</td> <td style="width: 41.4773%;">Click <a href="https://redcap01.nottingham.ac.uk/redcap_v10.6.11/index.php?route=PdfController:index&pid=[project-id]&s=&page=consent_form_resident_without_capacity&id=[record-name]&event_id=143"><img src="/redcap_v10.6.11/Resources/images/pdf.gif" alt="" /></a> to download</td> </tr> </tbody> </table> Please confirm that you have seen a copy of the patient's Informed Consent Form Is the patient participating in any other COVID-19 prevention or treatment trial? Eligibility - No <div style="font-size:120%;text-align:center;padding-top:10px;color:white;background-color:purple;">Eligibility - No </div> xxxxxxxxxxxClick to view Exclusions and contraindications {cic_appen} Is the patient already taking, or in definite need for, an inhaled or intranasal corticosteroid? {cort:icons} Does the patient have a known allergy/hypersensitivity to xxxxxxxxxxx? {cic_allergy:icons} Does the patient have severe liver impairment? {liver_imp:icons} <div class="rich-text-field-label"><table style="border-collapse: collapse; width: 100%; height: 146px;" border="0"> <tbody> <tr style="height: 25px;"> <td style="height: 25px; width: 59.3484%;"><span style="font-size: 110%; color: purple;">xxxxxxxxxxx</span><span id="view_cic" style="float: right; padding-right: 20px; color: #000066; font-size: 90%;"><u>Click to view Exclusions and contraindications</u></span></td> <td style="font-size: 110%; color: purple; width: 40.5099%; height: 25px;"><strong>{cic_appen}</strong></td> </tr> <tr style="height: 18px;"> <td style="width: 59.3484%; height: 18px;"> <p>Is the patient already taking, or in definite need for, an inhaled or intranasal corticosteroid?</p> </td> <td style="width: 40.5099%; height: 18px;">{cort:icons}</td> </tr> <tr style="height: 59px;"> <td style="width: 59.3484%; height: 59px;">Does the patient have a known allergy/hypersensitivity to xxxxxxxxxxx?</td> <td style="width: 40.5099%; height: 59px;">{cic_allergy:icons}</td> </tr> <tr style="height: 44px;"> <td style="width: 59.3484%; height: 44px;"> <p>Does the patient have severe liver impairment?</p> </td> <td style="width: 40.5099%; height: 44px;">{liver_imp:icons}</td> </tr> </tbody> </table></div> Exclusions and contraindications for xxxxxxxxxxx click here to hide 1. Already taking, or definite need for, an inhaled or intranasal corticosteroid: beclometasone dipropionate (aerosol inhaler and dry powder inhaler), budesonide (dry powder inhaler and single-dose units for nebulization), xxxxxxxxxxx (aerosol inhaler), fluticasone propionate (dry powder inhaler, aerosol inhaler, and single-dose units for nebulization), mometasone furoate (dry powder inhaler). 2. Known allergy/hypersensitivity to xxxxxxxxxxx. 3. Received a live vaccine within last 14 days - xxxxxxxxxxx increases risk of generalised infection: influenza, MMR, rotavirus, typhoid, varicella-zoster (shingles), yellow fever.     4. Severe liver impairment. <div class="rich-text-field-label"><table id="cic" style="border-collapse: collapse; width: 100%; height: 108px; background-color: #d8ecf3;" border="0" cellspacing="0" cellpadding="0"> <tbody> <tr style="height: 11px;"> <td style="width: 99.102%; vertical-align: top; padding: 10px 0px; height: 11px;" colspan="2">Exclusions and contraindications for xxxxxxxxxxx <span id="cic_text" style="margin-left: 20%;"><u>click here to hide</u></span></td> </tr> <tr style="height: 80px;"> <td style="width: 1.95893%; height: 20px; vertical-align: top;">1.</td> <td style="vertical-align: top; width: 97.1431%; height: 20px;">Already taking, or definite need for, an inhaled or intranasal corticosteroid: beclometasone dipropionate (aerosol inhaler and dry powder inhaler), budesonide (dry powder inhaler and single-dose units for nebulization), xxxxxxxxxxx (aerosol inhaler), fluticasone propionate (dry powder inhaler, aerosol inhaler, and single-dose units for nebulization), mometasone furoate (dry powder inhaler).</td> </tr> <tr style="height: 28px;"> <td style="vertical-align: top; width: 1.95893%; height: 10px;">2.</td> <td style="vertical-align: top; width: 97.1431%; height: 10px;">Known allergy/hypersensitivity to xxxxxxxxxxx.</td> </tr> <tr style="height: 45px;"> <td style="vertical-align: top; width: 1.95893%; height: 37px;">3.</td> <td style="vertical-align: top; width: 97.1431%; height: 37px;">Received a live vaccine within last 14 days - xxxxxxxxxxx increases risk of generalised infection: influenza, MMR, rotavirus, typhoid, varicella-zoster (shingles), yellow fever.    </td> </tr> <tr style="height: 30px;"> <td style="vertical-align: top; width: 1.95893%; height: 30px;">4.</td> <td style="vertical-align: top; width: 97.1431%; height: 30px;">Severe liver impairment.</td> </tr> </tbody> </table></div> Is the patient already taking, or in definite need for, an inhaled or intranasal corticosteroid? Does the patient have a known allergy/hypersensitivity to xxxxxxxxxxx? Does the patient have severe liver impairment?󠄇 cic_yes (hidden) show_cic (hidden) xxxxxxxxxxxClick to view Exclusions and contraindications {nic_appen} Is the patient already taking, or in definite need for, xxxxxxxxxxx?  {niclo:icons} Does the patient have a known allergy/hypersensitivity to xxxxxxxxxxx? {nic_allergy:icons} <div class="rich-text-field-label"><table style="border-collapse: collapse; width: 100%; height: 89px;" border="0"> <tbody> <tr style="height: 25px;"> <td style="height: 28px; width: 59.3484%;"><span style="font-size: 110%; color: purple;">xxxxxxxxxxx</span><span id="view_nic" style="float: right; padding-right: 20px; color: #000066; font-size: 90%;"><u>Click to view Exclusions and contraindications</u></span></td> <td style="color: purple; font-size: 110%; width: 40.5099%;">{nic_appen}</td> </tr> <tr style="height: 18px;"> <td style="width: 59.3484%; height: 13px;"> <p>Is the patient already taking, or in definite need for, xxxxxxxxxxx? </p> </td> <td style="width: 40.5099%; height: 13px;">{niclo:icons}</td> </tr> <tr style="height: 59px;"> <td style="width: 59.3484%; height: 48px;">Does the patient have a known allergy/hypersensitivity to xxxxxxxxxxx?</td> <td style="width: 40.5099%; height: 48px;">{nic_allergy:icons}</td> </tr> </tbody> </table></div> Exclusions and contraindications for xxxxxxxxxxx click here to hide 1. Already taking, or definite need for, xxxxxxxxxxx. 2. Known allergy/hypersensitivity to xxxxxxxxxxx. <div class="rich-text-field-label"><table id="nic" style="border-collapse: collapse; width: 100%; height: 67px; background-color: #d8ecf3;" border="0" cellspacing="0" cellpadding="0"> <tbody> <tr style="height: 25px;"> <td style="width: 99.102%; height: 20px;" colspan="2">Exclusions and contraindications for xxxxxxxxxxx <span id="nic_text" style="margin-left: 20%;"><u>click here to hide</u></span></td> </tr> <tr style="height: 25px;"> <td style="width: 1.81729%; height: 10px;">1.</td> <td style="width: 97.2847%; height: 10px;">Already taking, or definite need for, xxxxxxxxxxx.</td> </tr> <tr style="height: 17px;"> <td style="width: 1.81729%; height: 37px;">2.</td> <td style="width: 97.2847%; height: 37px;">Known allergy/hypersensitivity to xxxxxxxxxxx.</td> </tr> </tbody> </table></div> Is the patient already taking, or in definite need for, xxxxxxxxxxx? Does the patient have a known allergy/hypersensitivity to xxxxxxxxxxx? nic_yes (hidden) show_nic (hidden) answer_gp_all (hidden) elig_score (hidden) To next stage after GP eligibility (1 is yes) elig_result (hidden) Based on the information you have provided, the resident is eligible to be prescribed [elig_result] <div style="text-align: center; background-color: purple; color: white; padding-top: 10px;">Based on the information you have provided, the resident is eligible to be prescribed<br /> <div style="font-size: 110%;"><br />[elig_result]</div> </div> Name of person completing eligibility checks (must be medically qualified) Signature Date of eligibility assessment Reminder: Please ensure a copy of [consent_arm_1][pt_firstname] [consent_arm_1][pt_lastname]'s Summary Care Record is uploaded in secure vault. Reminder: Please ensure a copy of [consent_arm_1][pt_firstname] [consent_arm_1][pt_lastname]'s <span="font-size:110%;">Summary Care Record</span> is uploaded in <a href="https://protect-vault.nottingham.ac.uk/?id=[record-name]&type=GP" target="_blank">secure vault</a>. gp_plr_email to setup eligibility email after gp eligibility completed (hidden) gp_plr_firstname to setup eligibility email after gp eligibility completed (hidden) Complete? GP eligibility form is not completed, come back later <div style="color:red;font-size:120%;">GP eligibility form is not completed, come back later</div> Has the Summary Care Record been uploaded to the secure vault? Date of vault was checked Not uploaded reason Complete? NCTU hasn't checked if SCR is uploaded in the secure vault <div style="color:red">NCTU hasn't checked if SCR is uploaded in the secure vault</div> NCTU checked SCR is not in the secure vault <div style="color:red">NCTU checked SCR is not in the secure vault</div> Outbreak Date Participant's name [consent_arm_1][pt_firstname] [consent_arm_1][pt_lastname] Participant's trial ID [record-name] Resident's NHS/CHI Number [consent_arm_1][nhs_no] Care Home Name [record-dag-label] GP Practice Name  [consent_arm_1][gp_practice] <table style="font-size: 110%; border-collapse: collapse; width: 100%; height: 75px; margin: 10px 0;"> <tbody> <tr style="height: 20px;"> <td style="width: 28.6281%; height: 10px;">Participant's name</td> <td style="width: 70.3574%; height: 10px; color: blue;"><strong>[consent_arm_1][pt_firstname] [consent_arm_1][pt_lastname]</strong></td> </tr> <tr style="height: 20px;"> <td style="width: 28.6281%; height: 21px;">Participant's trial ID</td> <td style="color: blue; width: 70.3574%; height: 21px;"><strong>[record-name]</strong></td> </tr> <tr style="height: 20px;"> <td style="width: 28.6281%; height: 18px;">Resident's NHS/CHI Number</td> <td style="width: 70.3574%; height: 18px; color: blue;"><strong>[consent_arm_1][nhs_no]</strong></td> </tr> <tr style="height: 20px;"> <td style="width: 28.6281%; height: 26px;">Care Home Name</td> <td style="width: 70.3574%; height: 26px; color: blue;">[record-dag-label]</td> </tr> <tr> <td style="width: 28.6281%;">GP Practice Name</td> <td style="width: 70.3574%; color: blue;"> <strong>[consent_arm_1][gp_practice]</strong></td> </tr> </tbody> </table> There is no vaccination history 14 day prior to today.<p>There is no vaccination history 14 day prior to today.</a></p> Vaccination History<p><a href="../DataEntry/index.php?pid=37&page=vaccination_status&id=[record-name]&event_id=145">Vaccination History</a></p> Summary of GP eligibility assessment xxxxxxxxxxx xxxxxxxxxxx Is the patient already taking, or in definite need for, an inhaled or intranasal corticosteroid? [cort] Is the patient already taking, or in definite need for, xxxxxxxxxxx? [niclo] Does the patient have a known allergy/hypersensitivity to xxxxxxxxxxx? [cic_allergy] Does the patient have a known allergy/hypersensitivity to xxxxxxxxxxx? [nic_allergy] Does the patient have severe liver impairment?󠄇   [liver_imp]   <div class="rich-text-field-label"><div style="padding: 10px 0 5px 0; font-size: 110%;">Summary of GP eligibility assessment</div> <table style="border-collapse: collapse; width: 100%; height: 176px;" border="1"> <tbody> <tr style="height: 29px;"> <td style="width: 48.9392%; height: 29px;" colspan="2">xxxxxxxxxxx</td> <td style="width: 49.222%; height: 29px;" colspan="2">xxxxxxxxxxx</td> </tr> <tr style="height: 18px;"> <td style="width: 43.4696%; height: 43px; padding: 5px;">Is the patient already taking, or in definite need for, an inhaled or intranasal corticosteroid?</td> <td style="width: 5.4696%; height: 43px;">[cort]</td> <td style="width: 43.611%; height: 43px; padding: 5px;">Is the patient already taking, or in definite need for, xxxxxxxxxxx?</td> <td style="width: 5.611%; height: 43px;">[niclo]</td> </tr> <tr style="height: 18px;"> <td style="width: 43.4696%; height: 48px; padding: 5px;">Does the patient have a known allergy/hypersensitivity to xxxxxxxxxxx?</td> <td style="width: 5.4696%; height: 48px;">[cic_allergy]</td> <td style="width: 43.611%; height: 48px; padding: 5px;">Does the patient have a known allergy/hypersensitivity to xxxxxxxxxxx?</td> <td style="width: 5.611%; height: 48px;">[nic_allergy]</td> </tr> <tr style="height: 56px;"> <td style="width: 43.4696%; height: 56px; padding: 5px;">Does the patient have severe liver impairment?󠄇</td> <td style="width: 5.4696%; height: 56px;">  <p>[liver_imp]</p> </td> <td style="width: 49.222%; height: 56px;" colspan="2"> </td> </tr> </tbody> </table></div> Based on GP information potentially eligible to be prescribed - '[elig_result]' <p>Based on GP information potentially eligible to be prescribed - '<span style="color:purple;">[elig_result]</span>'<br /></p> Have you reviewed a copy of the resident's Summary Care Record? Have you reviewed a copy of the resident's Medication Administration Record? xxxxxxxxxxxClick to view Exclusions and contraindications {cic_append} Is the resident already taking an inhaled or intranasal corticosteroid (e.g. budesonide, xxxxxxxxxxx)? {pi_cort:icons} Has the resident received a live vaccine within last 14 days? - xxxxxxxxxxx increases risk of generalised infection: influenza (xxxxxxxxxxx), MMR, rotavirus, typhoid, varicella-zoster (shingles), yellow fever.  {liver_vaccine:icons} Does the resident have any definite need for, or contraindication to, xxxxxxxxxxx? {cic_cont:icons} <table style="border-collapse: collapse; width: 100%; height: 191px;" border="0"> <tbody> <tr style="height: 25px; background: #FFFFE0;"> <td style="height: 44px; width: 60.0567%;"><span style="font-size: 110%; color: purple;">xxxxxxxxxxx</span><span id="view_cic" style="float: right; padding-right: 20px;color:#000066;"><u>Click to view Exclusions and contraindications</u></span></td> <td style="font-size: 110%; width: 39.9433%; height: 44px;"><strong>{cic_append}</strong></td> </tr> <tr style="height: 18px;"> <td style="width: 60.0567%; height: 18px;"> <p>Is the resident already taking an inhaled or intranasal corticosteroid (e.g. budesonide, xxxxxxxxxxx)?</p> </td> <td style="width: 39.9433%; height: 18px;">{pi_cort:icons}</td> </tr> <tr style="height: 59px;"> <td style="width: 60.0567%; height: 85px;">Has the resident received a live vaccine within last 14 days? - xxxxxxxxxxx increases risk of generalised infection: influenza (xxxxxxxxxxx), MMR, rotavirus, typhoid, varicella-zoster (shingles), yellow fever. </td> <td style="width: 39.9433%; height: 85px;">{liver_vaccine:icons}</td> </tr> <tr style="height: 44px;"> <td style="width: 60.0567%; height: 44px;">Does the resident have any definite need for, or contraindication to, xxxxxxxxxxx?</td> <td style="width: 39.9433%; height: 44px;">{cic_cont:icons}</td> </tr> </tbody> </table> Exclusions and contraindications for xxxxxxxxxxx click here to hide 1. Already taking, or definite need for, an inhaled or intranasal corticosteroid: beclometasone dipropionate (aerosol inhaler and dry powder inhaler), budesonide (dry powder inhaler and single-dose units for nebulization), xxxxxxxxxxx (aerosol inhaler), fluticasone propionate (dry powder inhaler, aerosol inhaler, and single-dose units for nebulization), mometasone furoate (dry powder inhaler). 2. Known allergy/hypersensitivity to xxxxxxxxxxx. 3. Received a live vaccine within last 14 days - xxxxxxxxxxx increases risk of generalised infection: influenza, MMR, rotavirus, typhoid, varicella-zoster (shingles), yellow fever.     4. Severe liver impairment. <div class="rich-text-field-label"><table id="cic" style="border-collapse: collapse; width: 100%; height: 108px; background-color: #d8ecf3;" border="0" cellspacing="0" cellpadding="0"> <tbody> <tr style="height: 11px;"> <td style="width: 99.102%; vertical-align: top; padding: 10px 0px; height: 11px;" colspan="2">Exclusions and contraindications for xxxxxxxxxxx <span id="cic_text" style="margin-left: 20%;"><u>click here to hide</u></span></td> </tr> <tr style="height: 80px;"> <td style="width: 1.95893%; height: 20px; vertical-align: top;">1.</td> <td style="vertical-align: top; width: 97.1431%; height: 20px;">Already taking, or definite need for, an inhaled or intranasal corticosteroid: beclometasone dipropionate (aerosol inhaler and dry powder inhaler), budesonide (dry powder inhaler and single-dose units for nebulization), xxxxxxxxxxx (aerosol inhaler), fluticasone propionate (dry powder inhaler, aerosol inhaler, and single-dose units for nebulization), mometasone furoate (dry powder inhaler).</td> </tr> <tr style="height: 28px;"> <td style="vertical-align: top; width: 1.95893%; height: 10px;">2.</td> <td style="vertical-align: top; width: 97.1431%; height: 10px;">Known allergy/hypersensitivity to xxxxxxxxxxx.</td> </tr> <tr style="height: 45px;"> <td style="vertical-align: top; width: 1.95893%; height: 37px;">3.</td> <td style="vertical-align: top; width: 97.1431%; height: 37px;">Received a live vaccine within last 14 days - xxxxxxxxxxx increases risk of generalised infection: influenza, MMR, rotavirus, typhoid, varicella-zoster (shingles), yellow fever.    </td> </tr> <tr style="height: 30px;"> <td style="vertical-align: top; width: 1.95893%; height: 30px;">4.</td> <td style="vertical-align: top; width: 97.1431%; height: 30px;">Severe liver impairment.</td> </tr> </tbody> </table></div> pi_cort liver_vaccine cic_cont cic_yes_pi (hidden) xxxxxxxxxxxClick to view Exclusions and contraindications {nic_append} Is the resident already taking xxxxxxxxxxx?  {pi_nic:icons} Does the resident have any definite need for, or contraindication to, xxxxxxxxxxx? {nic_cont:icons} <table style="border-collapse: collapse; width: 100%; height: 77px;" border="0"> <tbody> <tr style="height: 25px;"> <td style="height: 40px; background: #ffffe0; width: 60.0567%;"><span style="font-size: 110%; color: purple;">xxxxxxxxxxx</span><span id="view_nic" style="float: right; padding-right: 20px;color:#000066;"><u>Click to view Exclusions and contraindications</u></span></td> <td style="font-size: 110%; background: #ffffe0; width: 39.9433%; height: 40px;"><strong>{nic_append}</strong></td> </tr> <tr style="height: 18px;"> <td style="width: 60.0567%; height: 10px;"> <p>Is the resident already taking xxxxxxxxxxx? </p> </td> <td style="width: 39.9433%; height: 10px;">{pi_nic:icons}</td> </tr> <tr style="height: 50px;"> <td style="width: 60.0567%; height: 27px;">Does the resident have any definite need for, or contraindication to, xxxxxxxxxxx?</td> <td style="width: 39.9433%; height: 27px;">{nic_cont:icons}</td> </tr> </tbody> </table> Exclusions and contraindications for xxxxxxxxxxx click here to hide 1. Already taking, or definite need for, xxxxxxxxxxx. 2. Known allergy/hypersensitivity to xxxxxxxxxxx. <div class="rich-text-field-label"><table id="nic" style="border-collapse: collapse; width: 100%; height: 67px; background-color: #d8ecf3;" border="0" cellspacing="0" cellpadding="0"> <tbody> <tr style="height: 25px;"> <td style="width: 99.102%; height: 20px;" colspan="2">Exclusions and contraindications for xxxxxxxxxxx <span id="nic_text" style="margin-left: 20%;"><u>click here to hide</u></span></td> </tr> <tr style="height: 25px;"> <td style="width: 1.81729%; height: 10px;">1.</td> <td style="width: 97.2847%; height: 10px;">Already taking, or definite need for, xxxxxxxxxxx.</td> </tr> <tr style="height: 17px;"> <td style="width: 1.81729%; height: 37px;">2.</td> <td style="width: 97.2847%; height: 37px;">Known allergy/hypersensitivity to xxxxxxxxxxx.</td> </tr> </tbody> </table></div> pi_nic nic_cont nic_yes_pi (hidden) elig_score2 (hidden) PI Eligibility Based on the information provided, the resident is eligible to be prescribed: [elig_result2] <div style="text-align:center;background-color:purple;color:white;padding-top:10px;">Based on the information provided, the resident is eligible to be prescribed: <div style="font-size:110%;padding-top:5px;"><u>[elig_result2]</u></div> </div> Based on the information provided, the resident is eligible to be prescribed: Neither xxxxxxxxxxx nor xxxxxxxxxxx (this resident must not be prescribed trial treatment) <div style="text-align:center;background-color:purple;color:white;padding-top:10px;">Based on the information provided, the resident is eligible to be prescribed: <div style="font-size:110%;padding-top:5px;"><u>Neither xxxxxxxxxxx nor xxxxxxxxxxx</u> (<span style="color:red;">this resident must not be prescribed trial treatment</span>)</div> </div> PI GMC reference number Name of person confirming eligibility status Date of eligibility assessment pi_plr_email to send eligibility after gp eligibility completed (hidden) pi_plr_firstname to setup eligibility email after gp eligibility completed (hidden) Complete? Use the following definitions to determine the Resident Clinical Frailty Scale (CFS) status. Very fit People who are robust, active, energetic and motivated. These people commonly exercise regularly. They are among the fittest for their age. Well People who have no active disease symptoms but are less fit than Category 1. Often, they exercise or are very active occasionally, e.g. seasonally. Managing well People whose medical problems are well controlled, but are not regularly active beyond routine walking. Vulnerable While not dependent on others for daily help, often symptoms limit activities. A common complaint is being "slowed up", and/or being tired during the day. <p>Use the following definitions to determine the Resident Clinical Frailty Scale (CFS) status.</p> <ol style="margin: 0px;"> <li>Very fit</li> </ol> <p style="padding-left: 40px; margin: 0px;"><span style="font-weight: normal;">People who are robust, active, energetic and motivated. These people commonly exercise regularly. They are among the fittest for their age.</span></p> <ol start="2" style="margin: 0px;"> <li>Well</li> </ol> <p style="padding-left: 40px; margin: 0px;"><span style="font-weight: normal;">People who have no active disease symptoms but are less fit than Category 1. Often, they exercise or are very active occasionally, e.g. seasonally.</span></p> <ol start="3" style="margin: 0px;"> <li>Managing well</li> </ol> <p style="padding-left: 40px; margin: 0px;"><span style="font-weight: normal;">People whose medical problems are well controlled, but are not regularly active beyond routine walking.</span></p> <ol start="4" style="margin: 0px;"> <li>Vulnerable</li> </ol> <p style="padding-left: 40px; margin: 0px;"><span style="font-weight: normal;">While not dependent on others for daily help, often symptoms limit activities. A common complaint is being "slowed up", and/or being tired during the day.</span></p> <ol start="5" style="margin: 0px;"> <li> What is the Resident's Clinical Frailty Scale (CFS) status? Complete? Randomisation Date 60 Days after Randomisation Date 42 Days after Randomisation Date Randomisation Treatment Code Randomisation Treatment Randomisation Status Final Eligibility Check Is the resident eligible to continue in trial? [eligibility_arm_1][elig_score2] using elig_score2<u>Final Eligibility Check</U> Is the resident eligible to continue in trial? [eligibility_arm_1][elig_score2] using elig_score2 Number of weeks for allocated trial treatment: Number of Doses: The resident has withdrawn from providing trial data, please do NOT proceed collecting any further trial data. <span style="color: #e03e2d;">The resident has withdrawn from providing trial data, please do <u>NOT</u> proceed collecting any further trial data.</span> The resident will no longer take part in the treatment phase of the trial.<span style="color: #e03e2d;">The resident will no longer take part in the treatment phase of the trial.</span> The resident is not eligible for the treatment. There is NO treatment to be administered for this resident. Please do NOT proceed collecting any further trial data.<span style="color: #e03e2d;">The resident is not eligible for the treatment. There is <u>NO</u> treatment to be administered for this resident. Please do <u>NOT</u> proceed collecting any further trial data.</span> The resident central PI confirmation of eligibility was not completed. There is NO treatment to be administered for this resident. Please do NOT proceed collecting any further trial data.<span style="color: #e03e2d;">The resident central PI confirmation of eligibility was not completed. There is <u>NO</u> treatment to be administered for this resident. Please do <u>NOT</u> proceed collecting any further trial data.</span> The Centre has been randomised to the following trial treatment group:- [rand_treat] on [rand_date]. There is NO treatment to be administered for this group.The Centre has been randomised to the following trial treatment group:- [rand_treat] on [rand_date]. There is <u>NO</u> treatment to be administered for this group. The Centre has not been randomised yet. At this stage, there is nothing to complete at Follow up. The Centre has been randomised to the following trial treatment group:- [rand_treat] on [rand_date] The Centre has been randomised to the following trial treatment group:- <span style="color:purple;">[rand_treat]</span> on [rand_date] SAE URL plr_email to send eligibility after the randomisation (hidden) plr_firstname to setup eligibility email after randomised eligibility completed (hidden) Complete? Did the resident start the trial treatment?Did the resident <u><b>start</u></b> the trial treatment? Date of first dose Treatment Weeks (if treatment started): Treatment End Date Treatment Rand End Date Treatment End Date Reason the trial treatment was not started Please specify details: Please save the form and remember: Any events resulting in admission to hospital or death should also be reported using the COVID-19, Hospital Admission, Death form.<div class="rich-text-field-label"><p><u>Please save the form and remember:</u><br /><br />Any events resulting in admission to hospital or death should also be reported using the <a title="COVID-19, Hospital Admission, Death" href="[redcap-version-url]/DataEntry/index.php?pid=[project-id]&id=[record-name]&page=covid19_hospital_admission_death&event_id=149&instance=[event_log_arm_1][eventid][last-instance]" target="_blank" rel="noopener">COVID-19, Hospital Admission, Death</a> form.</p></div> Complete? [event-label] - [startdate] to [enddate] (inclusive) <p style="background-color: #FFFFE0;font-size:16px; "> [event-label] - [startdate] to [enddate] (inclusive) </p> The resident has reached the last week. Please continue to record any COVID-19, Hospital Admission, Death Events. <span style="color: #0000ff;font-size:14px;">The resident has reached the last week. Please continue to record any COVID-19, Hospital Admission, Death Events. </span> [event-label] - [startdate] to [enddate] (inclusive) The resident has reached the end of the trial treatment period and should not be given any further doses after the above date. <p style="background-color: #ffffe0;font-size:16px;"><br />[event-label] - [startdate] to [enddate] (inclusive)<br /><br /><span style="color: #0000ff;font-size:14px;">The resident has reached the end of the trial treatment period and should not be given any further doses after the above date. </span></p> [event-label] - [startdate] to [treat_enddate] (inclusive) The resident has reached the end of the trial treatment period and should not be given any further doses after the above date. Adverse Events also do not need to be reported outside these dates. Please note this is [treat_last_week_days] day(s) of reporting. <p style="background-color: #ffffe0;font-size:16px;"><br />[event-label] - [startdate] to [treat_enddate] (inclusive)<br /><br /><span style="color: #0000ff;font-size:14px;">The resident has reached the end of the trial treatment period and should not be given any further doses after the above date. Adverse Events also do not need to be reported outside these dates.<br />Please note this is [treat_last_week_days] day(s) of reporting. <br /> </span></p> Treatment End Date (Hidden) Treatment Last Week days (Hidden) Treatment days (Hidden) Previous week must be completed before you can progress to enter data. Last End Date (Hidden) Week Start Date (Hidden) Week End Date (Hidden) Maximum Dose for Week (Hidden) Is treatment administered? (Hidden) Has resident previously discontinued from treatment? (Hidden) Has resident previously died? (Hidden) There is no trial treatment to be administered this week. The number of doses of the allocated trial treatment can only be recorded at the end of [event-label]. The weekly data can only be recorded after the start of [event-label] The resident has discontinued from the trial treatment on a previous weekly form. Please amend if this is incorrect.<span style="color: #0000ff;font-size:14px;">The resident has discontinued from the trial treatment on a previous weekly form. Please amend if this is incorrect.</span> A death has been recorded on a previous weekly form. Please amend if this is incorrect.<span style="color: #0000ff;font-size:14px;">A death has been recorded on a previous weekly form. Please amend if this is incorrect.</span> A death has been recorded as reason the resident did not start treatment. Please amend if this is incorrect.<span style="color: #0000ff;font-size:14px;">A death has been recorded as reason the resident did not start treatment. Please amend if this is incorrect.</span> For xxxxxxxxxxx: The drug appendix for xxxxxxxxxxx describes dosage as twice daily, administered as follows: Intranasal 140 µL spray into each nostril = one push of the nozzle. If you were unable to administer a spray into each nostril, a spray or attempted spray into at least one nostril should still be reported as a dose.<div class="rich-text-field-label"><p><u>For xxxxxxxxxxx:</u></p> <p><span style="font-weight: normal;">The drug appendix for xxxxxxxxxxx describes dosage as twice daily, administered as follows:</span></p> <ul> <li><span style="font-weight: normal;">Intranasal 140 µL spray into each nostril = one push of the nozzle.</span></li> </ul> <p><span style="color: #e03e2d;">If you were unable to administer a spray into each nostril, a spray or attempted spray into at least one nostril should still be reported as a dose.</span></p></div> For xxxxxxxxxxx: The drug appendix for xxxxxxxxxxx describes dosage as once daily, administered as follows: Two puffs (320 µg) inhaled via mask via mouth sequentially. Participants who are unable to tolerate a face mask will use the spacer mouthpiece taking two puffs.  One puff (160 µg) inhaled via mask via nose. Participants who are unable to tolerate a face mask will not receive the intranasal puff.  If you were unable to administer the dose exactly as described above, any puff or attempted puff via the nose or mouth should still be reported as a dose.<div class="rich-text-field-label"><p><u>For C<strong>iclesonide</strong>:</u></p> <p><span style="font-weight: normal;">The drug appendix for xxxxxxxxxxx describes dosage as once daily, administered as follows:</span></p> <ul> <li><span style="font-weight: normal; color: #000000;">Two puffs (320 µg) inhaled via mask via mouth sequentially. Participants who are unable to tolerate a face mask will use the spacer mouthpiece taking two puffs. </span></li> <li><span style="font-weight: normal;">One puff (160 µg) inhaled via mask via nose. Participants who are unable to tolerate a face mask will not receive the intranasal puff. </span></li> </ul> <p><span style="color: #e03e2d;">If you were unable to administer the dose exactly as described above, any puff or attempted puff via the nose or mouth should still be reported as a dose.</span></p></div> How many doses of the trial treatment were taken during this period? Main reason for missing doses of the trial treatment Please specify details: Is the resident continuing with the trial treatment? Main reason for discontinuing the trial treatment early Please specify details: Date of last dose taken Steroid inhalers (e.g. budesonide, beclometasone,fluticasone, mometasone, xxxxxxxxxxx) Oral Steroids (e.g. prednisolone, hydrocortisone, dexmethasone, methyprednisolone) Gastrointestinal Nausea Vomiting outside of confirmed norovirus outbreak Unpleasant taste Indigestion, stomach ache Abdominal pain/cramps Gagging Diarrhoea outside of confirmed norovirus outbreak Loss of appetite Rectal itching Oral thrush <div class="rich-text-field-label"><p>Gastrointestinal</p> <ul> <li><span style="font-weight: normal;">Nausea</span></li> <li><span style="font-weight: normal;">Vomiting outside of confirmed norovirus outbreak</span></li> <li><span style="font-weight: normal;">Unpleasant taste</span></li> <li><span style="font-weight: normal;">Indigestion, stomach ache</span></li> <li><span style="font-weight: normal;">Abdominal pain/cramps</span></li> <li><span style="font-weight: normal;">Gagging</span></li> <li><span style="font-weight: normal;">Diarrhoea outside of confirmed norovirus outbreak</span></li> <li><span style="font-weight: normal;">Loss of appetite</span></li> <li><span style="font-weight: normal;">Rectal itching</span></li> <li><span style="font-weight: normal;">Oral thrush</span></li> </ul></div> Which of the following gastrointestinal symptoms did the resident experience and to what severity?Which of the following <u>gastrointestinal</u> symptoms did the resident experience and to what severity? Nausea Vomiting outside of confirmed norovirus outbreak Unpleasant taste Indigestion, stomach ache Abdominal pain/cramps Gagging Diarrhoea outside of confirmed norovirus outbreak Loss of appetite Rectal itching Oral thrush Neuro-psychiatric Anxiety Behavioural changes Depression Dizziness or light-headedness Drowsiness Headache Malaise Movements without purpose (psychomotor hyperactivity) Sleep disorders Aggression <div class="rich-text-field-label"><p>Neuro-psychiatric</p> <ul> <li><span style="font-weight: normal;">Anxiety</span></li> <li><span style="font-weight: normal;">Behavioural changes</span></li> <li><span style="font-weight: normal;">Depression</span></li> <li><span style="font-weight: normal;">Dizziness or light-headedness</span></li> <li><span style="font-weight: normal;">Drowsiness</span></li> <li><span style="font-weight: normal;">Headache</span></li> <li><span style="font-weight: normal;">Malaise</span></li> <li><span style="font-weight: normal;">Movements without purpose (psychomotor hyperactivity)</span></li> <li><span style="font-weight: normal;">Sleep disorders</span></li> <li><span style="font-weight: normal;">Aggression</span></li> </ul></div> Which of the following neuro-psychiatric symptoms did the resident experience and to what severity?Which of the following <u>neuro-psychiatric</u> symptoms did the resident experience and to what severity? Anxiety Behavioural changes Depression Dizziness or light-headedness Drowsiness Headache Malaise Movements without purpose (psychomotor hyperactivity) Sleep disorders Aggression Chest/Respiratory Cough Hoarse voice (dysphonia) Wheeze, new onset Haemoptysis (coughing blood) <div class="rich-text-field-label"><p>Chest/Respiratory</p> <ul> <li><span style="font-weight: normal;">Cough</span></li> <li><span style="font-weight: normal;">Hoarse voice (dysphonia)</span></li> <li><span style="font-weight: normal;">Wheeze, new onset</span></li> <li><span style="font-weight: normal;">Haemoptysis (coughing blood)</span></li> </ul></div> Which of the following chest/respiratory symptoms did the resident experience and to what severity?Which of the following <u>chest/respiratory</u> symptoms did the resident experience and to what severity? Cough Hoarse voice (dysphonia) Wheeze, new onset Haemoptysis (coughing blood) Cardiovascular Racing heart (Palpitations) High blood pressure (hypertension) New diabetes/hyperglycaemia <div class="rich-text-field-label"><p>Cardiovascular</p> <ul> <li><span style="font-weight: normal;">Racing heart (Palpitations)</span></li> <li><span style="font-weight: normal;">High blood pressure (hypertension)</span></li> <li><span style="font-weight: normal;">New diabetes/hyperglycaemia</span></li> </ul></div> Which of the following cardiovascular symptoms did the resident experience and to what severity?Which of the following <u>cardiovascular</u> symptoms did the resident experience and to what severity? Racing heart (Palpitations) High blood pressure (hypertension) New diabetes/hyperglycaemia Skin/Cutaneous Swollen mouth (angioedema) Hypersensitivity Itching (pruritus) Eczema or rash Sweating, excess (hyperhidrosis) Cyanosis (bluish discolouration) <div class="rich-text-field-label"><p>Skin/Cutaneous</p> <ul> <li><span style="font-weight: normal;">Swollen mouth (angioedema)</span></li> <li><span style="font-weight: normal;">Hypersensitivity</span></li> <li><span style="font-weight: normal;">Itching (pruritus)</span></li> <li><span style="font-weight: normal;">Eczema or rash</span></li> <li><span style="font-weight: normal;">Sweating, excess (hyperhidrosis)</span></li> <li><span style="font-weight: normal;">Cyanosis (bluish discolouration)</span></li> </ul></div> Which of the following skin/cutaneous symptoms did the resident experience and to what severity?Which of the following <u>skin/cutaneous</u> symptoms did the resident experience and to what severity? Swollen mouth (angioedema) Hypersensitivity Itching (pruritus) Eczema or rash Sweating, excess (hyperhidrosis) Cyanosis (bluish discolouration) Nasal Nasal discomfort Epistaxis (nose bleed) Nasal dryness Nasal drip <div class="rich-text-field-label"><p>Nasal</p> <ul> <li><span style="font-weight: normal;">Nasal discomfort</span></li> <li><span style="font-weight: normal;">Epistaxis (nose bleed)</span></li> <li><span style="font-weight: normal;">Nasal dryness</span></li> <li><span style="font-weight: normal;">Nasal drip</span></li> </ul></div> Which of the following nasal symptoms did the resident experience and to what severity?Which of the following <u>nasal</u> symptoms did the resident experience and to what severity? Nasal discomfort Epistaxis (nose bleed) Nasal dryness Nasal drip Please save the form and remember: Any events deemed to be life-threatening should be reported using the Serious Adverse Event form. Any events resulting in admission to hospital or death should also be reported using the COVID-19, Hospital Admission, Death form.<div class="rich-text-field-label"><p><u>Please save the form and remember:</u><br />Any events deemed to be life-threatening should be reported using the <a title="Serious Adverse Event" href="[redcap-version-url]/DataEntry/index.php?pid=[project-id]&id=[record-name]&page=serious_adverse_event&event_id=199&instance=[safety_reporting_arm_1][ae_next_event_id][last-instance]" target="_blank" rel="noopener">Serious Adverse Event</a> form.<br /><br />Any events resulting in admission to hospital or death should also be reported using the <a title="COVID-19, Hospital Admission, Death" href="[redcap-version-url]/DataEntry/index.php?pid=[project-id]&id=[record-name]&page=covid19_hospital_admission_death&event_id=149&instance=[event_log_arm_1][eventid][last-instance]" target="_blank" rel="noopener">COVID-19, Hospital Admission, Death</a> form.</p></div> Complete? Event ID Rand Date (Hidden) 60 Days from Rand (Hidden) What was event #[current-instance]? What was event #[current-instance]? What was event #[current-instance]? Has the resident experienced any COVID-19 symptoms? Date symptoms started Continuous cough Fever (38 degrees Celsius or higher) Loss or change to sense of taste/smell Loss of appetite New onset confusion Other Has the resident been tested for COVID-19? Date resident was tested Type of test taken Did the resident test positive for COVID-19? Has the resident received Dexamethasone in the care home for this COVID-19 event? Date the resident first received Dexamethasone in the care home for this COVID-19 event Has the resident received Oxygen in the care home for this COVID-19 event? Date the resident first received Oxygen in the care home for this COVID-19 event Did you seek any healthcare support for this COVID-19 event? e.g. discussion outside of care home with GP (excluding routine visit), 111, 999 paramedic or Emergency Department assessment, remote hospital consultation<div class="rich-text-field-label"><p>Did you seek any healthcare support for this COVID-19 event?<br /><em>e.g. discussion outside of care home with GP (excluding routine visit), 111, 999 paramedic or Emergency Department assessment, remote hospital consultation</em></p></div> Date healthcare support first sought for this COVID-19 event Main Reason for hospital admission Date admitted to hospital Please ensure you save the current form and complete a Serious Adverse Event form for this event.<div class="rich-text-field-label"><p><span style="color: #e03e2d; font-size: 15px;">Please ensure you save the current form and complete a <a title="Serious Adverse Event" href="[redcap-version-url]/DataEntry/index.php?pid=[project-id]&id=[record-name]&page=serious_adverse_event&event_id=199&instance=[safety_reporting_arm_1][ae_next_event_id][last-instance]" target="_blank" rel="noopener">Serious Adverse Event</a> form for this event.</span></p></div> Date of death If known, cause of death Was the resident in the care home at the time of death? Please save the current form and ensure you complete a Serious Adverse Event form for this event.<div class="rich-text-field-label"><p><span style="color: #e03e2d; font-size: 15px;">Please save the current form and ensure you complete a <a title="Serious Adverse Event" href="[redcap-version-url]/DataEntry/index.php?pid=[project-id]&id=[record-name]&page=serious_adverse_event&event_id=199&instance=[safety_reporting_arm_1][ae_next_event_id][last-instance]" target="_blank" rel="noopener">Serious Adverse Event</a> form for this event.</span></p></div> Complete? Date resident was tested Did the resident test positive for COVID-19? Complete? Date readmitted to care home Complete? Resident Id: [record-name] Date of birth: [consent_arm_1][dob] Gender: [consent_arm_1][gender] To be completed by care home staff or GP (only report Serious Adverse Events before [ae_end_date]): <div style="background-color: #FFFFE0;font-size:16px; "><table style="width: 100%; height: 120px;" border="1"> <tbody> <tr style="height: 18px;"> <td style="width: 31.9661%; height: 40px;">Resident Id:</td> <td style="width: 67.0439%; height: 40px;">[record-name]</td> </tr> <tr style="height: 18px;"> <td style="width: 31.9661%; height: 40px;">Date of birth:</td> <td style="width: 67.0439%; height: 40px;">[consent_arm_1][dob]</td> </tr> <tr style="height: 18px;"> <td style="width: 31.9661%; height: 40px;">Gender:</td> <td style="width: 67.0439%; height: 40px;">[consent_arm_1][gender]</td> </tr> </tbody> </table> To be completed by care home staff or GP (only report Serious Adverse Events before <span style="color: #ba372a;">[ae_end_date]</span>): </div> Next Instance Event Id Please select if you are reporting a new Serious Adverse Event or an update to existing Serious Adverse Event Please select the Serious Adverse Event you wish to update Please select the Serious Adverse Event you wish to update There are no previous events that have been evaluated that can be updated, please register this as a new Serious Adverse Event. Please contact PROTECT-CH team if you believe this is incorrect.<p><span style="color: #e03e2d;">There are no previous events that have been evaluated that can be updated, please register this as a new Serious Adverse Event.</span><br /><br /><span style="color: #e03e2d;">Please contact PROTECT-CH team if you believe this is incorrect.</span></p> To view previously reported Serious Adverse Event you wish to update click here<div class="rich-text-field-label"><p>To view previously reported Serious Adverse Event you wish to update <a href="[redcap-version-url]/DataEntry/index.php?pid=[project-id]&id=[record-name]&page=serious_adverse_event&event_id=199&instance=[safety_reporting_arm_1][ae_previous_event:value]" target="_blank" rel="noopener">click here</a></p></div> Date of event Rand Date (Hidden) Treatment Start Date (Hidden) Treatment Status (Hidden) PI Email (Hidden) Deputy PI Email (Hidden) GP Email (Hidden) CH Email (Hidden) Email Address for GP/CH (HIDDEN) Last adverse event reported Event name Event description What was the severity of the event? Serious Criteria Serious Criteria Serious Criteria Serious Criteria Serious Criteria Serious Criteria If other, please specify Had the resident started the allocated trial treatment at the time of the event? Date and time of last dose prior to onset of event Date of last dose prior to onset of event (HIDDEN) Action taken (Detail treatment and action taken and whether trial participation is to continue) What is outcome following action? Please specify details of any consequences:: Your name Date report completed Preferred contact number (a trial doctor may wish to contact you for more information) SAE Next URL Complete? click here to hide The following events are frequent in care homes and will not be evaluated as SAEs Agitation Allergic reaction (not related to trial medication) Anorexia, loss of appetite Bowel obstruction  Bruising, ecchymoses Confusion COVID-19 (part of the primary outcome)  Delirium Dehydration Diarrhoea, during confirmed norovirus or Clostridium difficile outbreak Fall with injury, with/without fracture Heart failure, volume overload Hypoglycaemia Hypotension Incontinence (urinary, bowel) Medication (non-trial) error Nursing care, missed Pressure ulcer Respiratory infection (non-COVID-19) Sepsis, bacteraemia Skin tear, abrasion, breakdown Suicide, attempted suicide, self-harm Surgical/procedural site infection Urinary tract infection, with/without catheter Venous thromboembolism Vomiting during confirmed norovirus outbreak Similarly, diagnoses present at baseline (including any worsening of that condition) and known co-morbidities should not be evaluated.   <div class="rich-text-field-label"><table id="display_events" style="border-collapse: collapse; width: 100%; height: 67px; background-color: #d8ecf3;" border="0" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="width: 99.102%; vertical-align: top; padding-top: 10px; padding-right: 0px; padding-bottom: 10px; text-align: right;"><span id="hide_events"><u>click here to hide</u></span></td> </tr> <tr style="height: 11px;"> <td style="width: 99.102%; vertical-align: top; padding: 10px 0px; height: 11px;">The following events are frequent in care homes and will not be evaluated as SAEs</td> </tr> <tr style="height: 80px;"> <td style="width: 99.102%; height: 20px; vertical-align: top;"> <ul> <li><span style="font-weight: normal;">Agitation</span></li> <li><span style="font-weight: normal;">Allergic reaction (not related to trial medication)</span></li> <li><span style="font-weight: normal;">Anorexia, loss of appetite</span></li> <li><span style="font-weight: normal;">Bowel obstruction</span></li> <li><span style="font-weight: normal;"> Bruising, ecchymoses</span></li> <li><span style="font-weight: normal;">Confusion</span></li> <li><span style="font-weight: normal;">COVID-19 (part of the primary outcome)</span></li> <li><span style="font-weight: normal;"> Delirium</span></li> <li><span style="font-weight: normal;">Dehydration</span></li> <li><span style="font-weight: normal;">Diarrhoea, during confirmed norovirus or Clostridium difficile outbreak</span></li> <li><span style="font-weight: normal;">Fall with injury, with/without fracture</span></li> <li><span style="font-weight: normal;">Heart failure, volume overload</span></li> <li><span style="font-weight: normal;">Hypoglycaemia</span></li> <li><span style="font-weight: normal;">Hypotension</span></li> <li><span style="font-weight: normal;">Incontinence (urinary, bowel)</span></li> <li><span style="font-weight: normal;">Medication (non-trial) error</span></li> <li><span style="font-weight: normal;">Nursing care, missed</span></li> <li><span style="font-weight: normal;">Pressure ulcer</span></li> <li><span style="font-weight: normal;">Respiratory infection (non-COVID-19)</span></li> <li><span style="font-weight: normal;">Sepsis, bacteraemia</span></li> <li><span style="font-weight: normal;">Skin tear, abrasion, breakdown</span></li> <li><span style="font-weight: normal;">Suicide, attempted suicide, self-harm</span></li> <li><span style="font-weight: normal;">Surgical/procedural site infection</span></li> <li><span style="font-weight: normal;">Urinary tract infection, with/without catheter</span></li> <li><span style="font-weight: normal;">Venous thromboembolism</span></li> <li><span style="font-weight: normal;">Vomiting during confirmed norovirus outbreak</span></li> </ul> </td> </tr> <tr style="height: 36px;"> <td style="width: 99.102%; vertical-align: top; height: 36px;"> <p>Similarly, diagnoses present at baseline (including any worsening of that condition) and known co-morbidities should not be evaluated.</p> <p> </p> </td> </tr> </tbody> </table></div> click here to hide The following events are frequent in care homes and will not be evaluated SAEs Agitation Allergic reaction (not related to trial medication) Anorexia, loss of appetite Bowel obstruction Bruising, ecchymoses Confusion COVID-19 (part of the primary outcome) Delirium Dehydration Diarrhoea during confirmed norovirus or Clostridium difficile outbreak Fall with injury, with/without fracture Heart failure, volume overload Hypoglycaemia Hypotension Incontinence (urinary, bowel) Medication (non-trial) error Nursing care, missed Pressure ulcer Respiratory infection (non-COVID-19) Sepsis, bacteraemia Skin tear, abrasion, breakdown Suicide, attempted suicide, self-harm Surgical/procedural site infection Urinary tract infection, with/without catheter Venous thromboembolism Vomiting during confirmed norovirus outbreak Similarly, diagnoses present at baseline (including any worsening of that condition) and known co-morbidities should not be evaluated.   <div class="rich-text-field-label"><table id="display_events_nodose" style="border-collapse: collapse; width: 100%; height: 67px; background-color: #d8ecf3;" border="0" cellspacing="0" cellpadding="0"> <tbody> <tr> <td style="width: 99.102%; vertical-align: top; padding-top: 10px; padding-right: 0px; padding-bottom: 10px; text-align: right;"><span id="hide_events_nodose"><u>click here to hide</u></span></td> </tr> <tr style="height: 11px;"> <td style="width: 99.102%; vertical-align: top; padding: 10px 0px; height: 11px;">The following events are frequent in care homes and will not be evaluated SAEs</td> </tr> <tr style="height: 80px;"> <td style="width: 99.102%; height: 20px; vertical-align: top;"> <ul> <li><span style="font-weight: normal;">Agitation</span></li> <li><span style="font-weight: normal;">Allergic reaction (not related to trial medication)</span></li> <li><span style="font-weight: normal;">Anorexia, loss of appetite</span></li> <li><span style="font-weight: normal;">Bowel obstruction</span></li> <li><span style="font-weight: normal;">Bruising, ecchymoses</span></li> <li><span style="font-weight: normal;">Confusion</span></li> <li><span style="font-weight: normal;">COVID-19 (part of the primary outcome)</span></li> <li><span style="font-weight: normal;">Delirium</span></li> <li><span style="font-weight: normal;">Dehydration</span></li> <li><span style="font-weight: normal;">Diarrhoea during confirmed norovirus or Clostridium difficile outbreak</span></li> <li><span style="font-weight: normal;">Fall with injury, with/without fracture</span></li> <li><span style="font-weight: normal;">Heart failure, volume overload</span></li> <li><span style="font-weight: normal;">Hypoglycaemia</span></li> <li><span style="font-weight: normal;">Hypotension</span></li> <li><span style="font-weight: normal;">Incontinence (urinary, bowel)</span></li> <li><span style="font-weight: normal;">Medication (non-trial) error</span></li> <li><span style="font-weight: normal;">Nursing care, missed</span></li> <li><span style="font-weight: normal;">Pressure ulcer</span></li> <li><span style="font-weight: normal;">Respiratory infection (non-COVID-19)</span></li> <li><span style="font-weight: normal;">Sepsis, bacteraemia</span></li> <li><span style="font-weight: normal;">Skin tear, abrasion, breakdown</span></li> <li><span style="font-weight: normal;">Suicide, attempted suicide, self-harm</span></li> <li><span style="font-weight: normal;">Surgical/procedural site infection</span></li> <li><span style="font-weight: normal;">Urinary tract infection, with/without catheter</span></li> <li><span style="font-weight: normal;">Venous thromboembolism</span></li> <li><span style="font-weight: normal;">Vomiting during confirmed norovirus outbreak</span></li> </ul> </td> </tr> <tr style="height: 36px;"> <td style="width: 99.102%; vertical-align: top; height: 36px;"> <p>Similarly, diagnoses present at baseline (including any worsening of that condition) and known co-morbidities should not be evaluated.</p> <p> </p> </td> </tr> </tbody> </table></div> Causality: Relationship to IMP or trial treatment: Classification of event: Classification of event: Classification of event: Assessment completed by: Signature Sign off Date: Complete? What is outcome following action? Please specify details: Your name Date follow up completed Complete? MedDRA code:- The SAE has been evaluated to be incorrectly reported (NOT SAE) therefore MedDRA code does not need be entered.<span style="color: #0000ff;font-size:14px;">The SAE has been evaluated to be incorrectly reported (NOT SAE) therefore MedDRA code does not need be entered.</span> Complete? Click 'Watch video' below to see a demonstration of Healthcare Support data entry<div class="rich-text-field-label"><p>Click 'Watch video' below to see a demonstration of Healthcare Support data entry</p></div> Has the resident had any contact with any of these healthcare professionals or services, or contact been made on their behalf (face-to-face/remote)? GP Hospital Doctor Nurse Nurse Specialist Allied Health Professional (Physiotherapist or Occupational Therapist or Speech Language Therapist or Respiratory Therapist) Calls to 111 Calls to 999 <p>Has the resident had any contact with any of these healthcare professionals or services, or contact been made on their behalf (face-to-face/remote)?</p> <ul> <li><span style="font-weight: normal;">GP</span></li> <li><span style="font-weight: normal;">Hospital Doctor</span></li> <li><span style="font-weight: normal;">Nurse</span></li> <li><span style="font-weight: normal;">Nurse Specialist</span></li> <li><span style="font-weight: normal;">Allied Health Professional </span><span style="font-weight: normal;"><br>(Physiotherapist or Occupational Therapist or Speech Language Therapist or Respiratory Therapist)</span></li> <li><span style="font-weight: normal;">Calls to 111</span></li> <li><span style="font-weight: normal;">Calls to 999</span></li> </ul>   Face-to-Face        Remote                No contact GP {hc_type_gp:icons} Hospital Doctor {hc_type_hosp_doctor:icons} Nurse {hc_type_nurse:icons} Nurse Specialist {hc_type_nurse_specialist:icons} Allied Health Professional  (Physiotherapist or Occupational Therapist or Speech Language Therapist or Respiratory Therapist) {hc_type_allied_health_prof:icons}   * must provide value for each type of contact Tick all that apply (Face-to-Face and Remote or No contact) <div class="rich-text-field-label"><table style="border-collapse: collapse; width: 100%; height: 148px; border-style: none;" border="0"> <tbody> <tr style="height: 38px;"> <td style="width: 34.7595%; height: 38px;"> <p> </p> </td> <td style="width: 25.484%; height: 38px;"><span style="color: #ba372a;">Face-to-Face        Remote                No contact</span></td> </tr> <tr style="height: 38px;"> <td style="width: 34.7595%; height: 38px;"> <p>GP</p> </td> <td style="width: 25.484%; height: 38px;"> <p>{hc_type_gp:icons}</p> </td> </tr> <tr style="height: 18px;"> <td style="width: 34.7595%; height: 18px;"> <p>Hospital Doctor</p> </td> <td style="width: 25.484%; height: 18px;"> <p>{hc_type_hosp_doctor:icons}</p> </td> </tr> <tr style="height: 18px;"> <td style="width: 34.7595%; height: 18px;"> <p>Nurse</p> </td> <td style="width: 25.484%; height: 18px;"> <p>{hc_type_nurse:icons}</p> </td> </tr> <tr style="height: 18px;"> <td style="width: 34.7595%; height: 18px;"> <p>Nurse Specialist</p> </td> <td style="width: 25.484%; height: 18px;"> <p>{hc_type_nurse_specialist:icons}</p> </td> </tr> <tr style="height: 18px;"> <td style="width: 34.7595%; height: 18px;"> <p>Allied Health Professional <br />(Physiotherapist or Occupational Therapist or Speech Language Therapist or Respiratory Therapist)</p> </td> <td style="width: 25.484%; height: 18px;"> <p>{hc_type_allied_health_prof:icons}</p> </td> </tr> </tbody> </table> <div class="note" aria-hidden="true"> </div> <div class="note" aria-hidden="true"> <div class="requiredlabel" aria-label="Question required.">* must provide value for each type of contact</div> <div class="note" aria-hidden="true">Tick all that apply (Face-to-Face and Remote or No contact)</div> </div></div>     Calls made to                    No contact 111 {hc_type_111:icons} 999 {hc_type_999:icons} * must provide value for each type of call Tick option that applies<div class="rich-text-field-label"><p> </p> <table style="width: 100.141%; height: 148px; border-style: none;" border="0"> <tbody> <tr style="height: 38px;"> <td style="width: 34.7595%; height: 38px;"> <p> </p> </td> <td style="width: 25.484%; height: 38px;"><span style="color: #ba372a;">Calls made to                    No contact</span></td> </tr> <tr style="height: 38px;"> <td style="width: 34.7595%; height: 38px;"> <p>111</p> </td> <td style="width: 25.484%; height: 38px;"> <p>{hc_type_111:icons}</p> </td> </tr> <tr style="height: 18px;"> <td style="width: 34.7595%; height: 18px;"> <p>999</p> </td> <td style="width: 25.484%; height: 18px;"> <p>{hc_type_999:icons}</p> </td> </tr> </tbody> </table> <div class="requiredlabel" aria-label="Question required.">* must provide value for each type of call</div> <div class="note" aria-hidden="true">Tick option that applies</div></div> GP GP GP Hospital Doctor Hospital Doctor Hospital Doctor Nurse Nurse Nurse Nurse Specialist Nurse Specialist Nurse Specialist Allied Health Professional (Physiotherapist or Occupational Therapist or Speech Language Therapist or Respiratory Therapist) Allied Health Professional (Physiotherapist or Occupational Therapist or Speech Language Therapist or Respiratory Therapist) Allied Health Professional (Physiotherapist or Occupational Therapist or Speech Language Therapist or Respiratory Therapist) 111 111 999 999 GP Contacts Number of GP (face-to-face) contacts:Number of <u>GP (face-to-face)</u> contacts: 1 The value you provided is outside the suggested range. (1 - 50). This value is admissible, but you may wish to double check it. 50 The value you provided is outside the suggested range. (1 - 50). This value is admissible, but you may wish to double check it. Number of GP (remote) contacts:Number of <u>GP (remote)</u> contacts: 1 The value you provided is outside the suggested range. (1 - 50). This value is admissible, but you may wish to double check it. 50 The value you provided is outside the suggested range. (1 - 50). This value is admissible, but you may wish to double check it. Hospital Doctor Contacts Number of hospital doctor (face-to-face) contacts:Number of <u>hospital doctor (face-to-face)</u> contacts: 1 The value you provided is outside the suggested range. (1 - 50). This value is admissible, but you may wish to double check it. 50 The value you provided is outside the suggested range. (1 - 50). This value is admissible, but you may wish to double check it. Number of hospital doctor (remote) contacts:Number of <u>hospital doctor (remote)</u> contacts: 1 The value you provided is outside the suggested range. (1 - 50). This value is admissible, but you may wish to double check it. 50 The value you provided is outside the suggested range. (1 - 50). This value is admissible, but you may wish to double check it. Number of nurse (face-to-face) contacts:Number of <u>nurse (face-to-face)</u> contacts: 1 The value you provided is outside the suggested range. (1 - 50). This value is admissible, but you may wish to double check it. 50 The value you provided is outside the suggested range. (1 - 50). This value is admissible, but you may wish to double check it. Number of nurse (remote) contacts:Number of <u>nurse (remote)</u> contacts: 1 The value you provided is outside the suggested range. (1 - 50). This value is admissible, but you may wish to double check it. 50 The value you provided is outside the suggested range. (1 - 50). This value is admissible, but you may wish to double check it. Number of nurse specialist (face-to-face) contacts:Number of <u>nurse specialist (face-to-face)</u> contacts: 1 The value you provided is outside the suggested range. (1 - 50). This value is admissible, but you may wish to double check it. 50 The value you provided is outside the suggested range. (1 - 50). This value is admissible, but you may wish to double check it. Number of nurse specialist (remote) contacts:Number of <u>nurse specialist (remote)</u> contacts: 1 The value you provided is outside the suggested range. (1 - 50). This value is admissible, but you may wish to double check it. 50 The value you provided is outside the suggested range. (1 - 50). This value is admissible, but you may wish to double check it. Number of allied health professional (face-to-face) contacts:Number of <u>allied health professional (face-to-face)</u> contacts: 1 The value you provided is outside the suggested range. (1 - 50). This value is admissible, but you may wish to double check it. 50 The value you provided is outside the suggested range. (1 - 50). This value is admissible, but you may wish to double check it. Number of allied health professional (remote) contacts:Number of <u>allied health professional (remote)</u> contacts: 1 The value you provided is outside the suggested range. (1 - 50). This value is admissible, but you may wish to double check it. 50 The value you provided is outside the suggested range. (1 - 50). This value is admissible, but you may wish to double check it. How many times was 111 contacted?How many times was <u>111</u> contacted? 1 The value you provided is outside the suggested range. (1 - 50). This value is admissible, but you may wish to double check it. 50 The value you provided is outside the suggested range. (1 - 50). This value is admissible, but you may wish to double check it. How many times was 999 contacted?How many times was <u>999</u> contacted? 1 The value you provided is outside the suggested range. (1 - 50). This value is admissible, but you may wish to double check it. 50 The value you provided is outside the suggested range. (1 - 50). This value is admissible, but you may wish to double check it. Complete? Date of 60 day check Has the resident had COVID-19, been admitted to hospital or died? Please confirm all COVID-19, hospital admissions and deaths are reported accurately Please confirm <u>all</u> COVID-19, hospital admissions and deaths are reported accurately Has the resident had a serious adverse event? Please confirm all Serious Adverse Events are reported accurately Please confirm <u>all</u> Serious Adverse Events are reported accurately Please confirm all doses of COVID-19 vaccination are reported accuratelyPlease confirm <u>all</u> doses of COVID-19 vaccination are reported accurately Please confirm that all weekly data forms (treatment and adverse events) are reported accuratelyPlease confirm that <u>all</u> weekly data forms (treatment and adverse events) are reported accurately As the resident has experienced an unreported health event, please complete a COVID-19, Hospital Admission, Death form for the resident.<div class="rich-text-field-label"><p>As the resident has experienced an unreported health event, please complete a <a title="COVID-19, Hospital Admission, Death" href="[redcap-version-url]/DataEntry/index.php?pid=[project-id]&id=[record-name]&page=covid19_hospital_admission_death&event_id=149&instance=[event_log_arm_1][eventid][last-instance]" target="_blank" rel="noopener">COVID-19, Hospital Admission, Death</a> form for the resident.</p></div> As the resident has experienced an unreported serious adverse event, please complete a Serious Adverse Event form for the resident.<div class="rich-text-field-label"><p>As the resident has experienced an unreported serious adverse event, please complete a <a title="Serious Adverse Event" href="[redcap-version-url]/DataEntry/index.php?pid=[project-id]&id=[record-name]&page=serious_adverse_event&event_id=199&instance=[safety_reporting_arm_1][ae_next_event_id][last-instance]" target="_blank" rel="noopener">Serious Adverse Event</a> form for the resident.</p></div> Complete? [consent_arm_1][ctype] is no longer interested <div style="font-size:110%;">[consent_arm_1][ctype] is no longer interested</div> This form should be used to document any change in involvement for residents who have given their consent to participate in the trial. You can select any/all that apply. This form can be revisited should further adjustments be made in the future. <div style="font-size:110%;"> This form should be used to document any change in involvement for residents who have given their consent to participate in the trial. You can select any/all that apply. This form can be revisited should further adjustments be made in the future.</div> The resident will no longer take part in the treatment phase of the trial <div style="font-size:110%;">The resident will no longer take part in the treatment phase of the trial</div> Please state the reason why the resident will no longer take part in the treatment phase of the trial: <div style="font-size:110%;">Please state the reason why the resident will no longer take part in the treatment phase of the trial:</div> The resident will provide no further trial data (i.e. data captured within the REDCap database) <div style="font-size:110%;">The resident will provide no further trial data (i.e. data captured within the REDCap database)</div> PLEASE NOTE THAT NO FURTHER TRIAL TREATMENT SHOULD BE ADMINISTERED FOR RESIDENTS WHO ARE NO LONGER PROVIDING TRIAL DATA. PLEASE ENSURE THAT THE RESIDENTS DISCONTINUATION OF TREATMENT IS RECORDED IN THE RELEVANT WEEKLY DATA FORM. <div style="font-size:110%;">PLEASE NOTE THAT NO FURTHER TRIAL TREATMENT SHOULD BE ADMINISTERED FOR RESIDENTS WHO ARE NO LONGER PROVIDING TRIAL DATA. PLEASE ENSURE THAT THE RESIDENTS DISCONTINUATION OF TREATMENT IS RECORDED IN THE RELEVANT WEEKLY DATA FORM.</div> Date last trial data collected <div style="font-size:110%;">Date last trial data collected</div> Please state the reason why the resident will provide no further data data captured up to this point will still be used for analysis <div style="font-size:110%;">Please state the reason why the resident will provide no further data <i>data captured up to this point will still be used for analysis</i></div> please specify The resident (or personal legal representative) has stated that they no longer wish for data to be collected from routine sources - data captured up to this point will still be used for analysis <div style="font-size:110%;">The resident (or personal legal representative) has stated that they no longer wish for data to be collected from routine sources - data captured up to this point will still be used for analysis</i></div> Date of cease in activity <div style="font-size:110%;">Date of cease in activity</div> The resident will no longer take part in a trial interview <div style="font-size:110%;">The resident will no longer take part in a trial interview</div> Please state the reason why the resident will no longer take part in a trial interview <div style="font-size:110%;">Please state the reason why the resident will no longer take part in a trial interview</div> please specify<div style="font-size:110%;">please specify</div> Based on the information provided above, the resident will no longer take part any further trial activities (withdrawal of consent). Please ensure that all trial data is entered up to this date. <div style="background-color:#FFFFE0;font-size:110%;"> Based on the information provided above, the resident will no longer take part any further trial activities (withdrawal of consent). Please ensure that all trial data is entered up to this date. </div> Date of withdrawal of consent <div style="font-size:110%;">Date of withdrawal of consent</div> withdrawal type used on randomisation status form Complete? Date of suspected violation Describe the suspected protocol violation Name of person reporting suspected protocol violation Role of person reporting suspected protocol violation Date report completed Complete? Meets criteria for protocol violation? Violation category Violation category Violation category Violation category Violation category Further details on violation Name of person completing NCTU assessment Signature of person completing NCTU assessment Date of NCTU assessment Complete? The verification form can only be completed once all the forms in follow up (60 days) have been completed.<span style="color: #0000ff;font-size:14px;">The verification form can only be completed once all the forms in follow up (60 days) have been completed.</span> Please confirm all form(s) have been completed/reviewed Name of senior care home staff member Signature of senior care home staff member Date 2020-01-01 The value you provided is outside the suggested range. (2020-01-01 - no limit). This value is admissible, but you may wish to double check it. Complete? Yes No Checked Unchecked Online Paper Female Male Incomplete Unverified Complete Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Incomplete Unverified Complete Yes No Incomplete Unverified Complete Final v1.0_18 May 2021 Final v2.0_01 Jul 2021 Yes No Checked Unchecked Incomplete Unverified Complete Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Yes No Yes No Incomplete Unverified Complete Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Yes No Yes No Incomplete Unverified Complete No problems in walking about Slight problems in walking about Moderate problems in walking about Severe problems in walking about Unable to walk about No problems washing or dressing him/herself Slight problems washing or dressing him/herself Moderate problems washing or dressing him/herself Severe problems washing or dressing him/herself Unable to wash or dress him/herself No problems doing his/her usual activities Slight problems doing his/her usual activities Moderate problems doing his/her usual activities Severe problems doing his/her usual activities Unable to do his/her usual activities No pain or discomfort Slight pain or discomfort Moderate pain or discomfort Severe pain or discomfort Extreme pain or discomfort Not anxious or depressed Slightly anxious or depressed Moderately anxious or depressed Severely anxious or depressed Extremely anxious or depressed Incomplete Unverified Complete Yes No Incomplete Unverified Complete I have no problems in walking about I have slight problems in walking about I have moderate problems in walking about I have severe problems in walking about I am unable to walk about I have no problems washing or dressing myself I have slight problems washing or dressing myself I have moderate problems washing or dressing myself I have severe problems washing or dressing myself I am unable to wash or dress myself I have no problems doing my usual activities I have slight problems doing my usual activities I have moderate problems doing my usual activities I have severe problems doing my usual activities I am unable to do my usual activities I have no pain or discomfort I have slight pain or discomfort I have moderate pain or discomfort I have severe pain or discomfort I have extreme pain or discomfort I am not anxious or depressed I am slightly anxious or depressed I am moderately anxious or depressed I am severely anxious or depressed I am extremely anxious or depressed Incomplete Unverified Complete Checked Unchecked Incomplete Unverified Complete White (British, Irish, any other white background) Mixed (White and Black Caribbean, White and Black African, White and Asian, any other mixed background) Indian Pakistani Bangladeshi Chinese Black Caribbean Black African Any other ethnic group Not stated Not known Yes No Current smoker Previous smoker Non-smoker Yes No Yes No Incomplete Unverified Complete Yes No Yes No Yes No Incomplete Unverified Complete Incomplete Unverified Complete Checked Unchecked Checked Unchecked Checked Unchecked Online Paper Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Yes No Incomplete Unverified Complete COVID-19 Vaccination Other Vaccination COVID-19 Vaccination Pfizer Moderna AstraZeneca/Oxford Novavax Janssen Not known Other Pneumococcal vaccine Influenza vaccine Varicella-zoster vaccine Other vaccine Injection Spray Varivax Zostavax Varilrix Shingrix Other Incomplete Unverified Complete Yes No Yes No Yes No Yes No Yes No Yes No Yes No Incomplete Unverified Complete Yes No Incomplete Unverified Complete Yes No Yes No Yes No Yes No Yes No Yes No Yes No Incomplete Unverified Complete Very fit Well Managing well Vulnerable Mildly frail Moderately frail Severely frail Very severely frail Terminally ill Incomplete Unverified Complete Incomplete Unverified Complete Yes No Resident decision Primary care decision Care home staff decision Personal legal representative decision Lack of supply Admitted to Hospital Death Other Incomplete Unverified Complete Suspected adverse reaction (side effects) Resident decision Primary care decision Care home staff decision Personal legal representative decision Admitted to Hospital Death Awaiting delivery of trial treatment Resident reached the end of the treatment period Lack of supply Other Yes No Suspected adverse reaction (side effects) Resident decision Primary care decision Care home staff decision Personal legal representative decision Death Other Yes No Yes No Yes No none mild moderate severe none mild moderate severe none mild moderate severe none mild moderate severe none mild moderate severe none mild moderate severe none mild moderate severe none mild moderate severe none mild moderate severe none mild moderate severe Yes No none mild moderate severe none mild moderate severe none mild moderate severe none mild moderate severe none mild moderate severe none mild moderate severe none mild moderate severe none mild moderate severe none mild moderate severe none mild moderate severe Yes No none mild moderate severe none mild moderate severe none mild moderate severe none mild moderate severe Yes No none mild moderate severe none mild moderate severe none mild moderate severe Yes No none mild moderate severe none mild moderate severe none mild moderate severe none mild moderate severe none mild moderate severe none mild moderate severe Yes No none mild moderate severe none mild moderate severe none mild moderate severe none mild moderate severe Incomplete Unverified Complete Checked Unchecked Checked Unchecked Checked Unchecked Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Lateral flow PCR Yes No Inconclusive Awaiting results Yes No Yes No Yes No Yes No Incomplete Unverified Complete Yes No Inconclusive Incomplete Unverified Complete Incomplete Unverified Complete New Serious Adverse Event Update previous Serious Adverse Event Mild Moderate Severe Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Yes No Recovered Recovered with sequelae (i.e. a result or consequence of the adverse event)Recovered with sequelae <br> (i.e. a result or consequence of the adverse event) Event Ongoing Death Incomplete Unverified Complete Definitely Probably Possibly Not related <b>Not SAE</b> (incorrectly reported)<b>Not SAE</b> (incorrectly reported) <b> SAE</b> (serious, not related to IMP)<b> SAE</b> (serious, not related to IMP) <b> SAR</b> (related to IMP, not unexpected)<b> SAR</b> (related to IMP, not unexpected) <b>SUSAR</b> (related to IMP, unexpected)<b>SUSAR</b> (related to IMP, unexpected) <b>Not SAE</b> (incorrectly reported)<b>Not SAE</b> (incorrectly reported) <b> SAE</b> (serious, not related to IMP)<b> SAE</b> (serious, not related to IMP) <b>SUSAR</b> (related to IMP, unexpected)<b>SUSAR</b> (related to IMP, unexpected) <b>Not SAE</b> (incorrectly reported)<b>Not SAE</b> (incorrectly reported) <b> SAE</b> (serious, not related to IMP)<b> SAE</b> (serious, not related to IMP) Incomplete Unverified Complete Recovered Resolved with sequelae Death Incomplete Unverified Complete Incomplete Unverified Complete Yes No Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Incomplete Unverified Complete Yes No Checked Unchecked Yes No Checked Unchecked Checked Unchecked Checked Unchecked Incomplete Unverified Complete Checked Unchecked Checked Unchecked Resident/PLR decision Clinical decision Resident has died Resident no longer lives in the care home Checked Unchecked Resident/PLR decision Clinical decision Resident no longer lives in the care home Not known Other {nfur_oth:icons} Checked Unchecked Checked Unchecked Resident/PLR decision Not known Other {ninterview_oth} Incomplete Unverified Complete Care home staff Research Nurse PI Incomplete Unverified Complete Yes No Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Checked Unchecked Incomplete Unverified Complete Checked Unchecked Incomplete Unverified Complete