PhEAST trial – Pharyngeal Electrical Stimulation for Acute Stroke dysphagia Trial

Trial documents

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Approved protocol	» Please click here to view superseded documents Appendix L Austrian Consent Procedure V1.0 20220224.pdf Protocol Appendix M Cognition Sub Study Scales V2.0 20221219 clean.pdf Protocol Appendix N IQCODE v 1.0 20220617.pdf Protocol V10.0 20240508 Clean.pdf Protocol Appendix A Dysphagia Severity rating Scale v1.0 20210930.pdf Protocol Appendix B Functional oral intake scale (FOIS) v1.0 20210930.pdf Protocol Appendix C EAT-10 v1.0 20210930.pdf Protocol Appendix D Feeding status scale (FSS) v1.0 20210930.pdf Protocol Appendix E NIHSS v1.0 20210930.pdf Protocol Appendix F GCS v1.0 20210930.pdf Protocol Appendix G EuroQoL EQ-5D5L v1.0 20210930.pdf Protocol Appendix H mRs v1.0 20210930.pdf Protocol Appendix I Barthel Index v1.0 20210930.pdf Protocol Appendix J TICS-M v1.0 20210930.pdf Protocol Appendix K short ZDS v1.0 20210930.pdf

Expression of interest	Blank EOI Form.pdf

Trial documents	» Please click here to view superseded documents 21068 Sponsor Letter ENGLISH REC.pdf 21068 Sponsor letter SCOTTISH REC.pdf A1 - Trial Development Document File Note 20220214.pdf Aphasia Friendly Participant Information on PES Treatment v1.0 20240416.pdf Awareness Poster v2.0 20240508.pdf B.3 - RF1 TA011ParticipantScreeningEnrolmentLog.doc Biological Materials B7 File Note V1.0 20220218.pdf Cognition Subscales Visual Resource V1.0 20230420.docx Communication Aid For Use During PES Treatment v1.0 20240416 (1).pdf DMC Charter - Signed.pdf EAT 10 Visual resource V1.0 20230420.docx EQ5D5L Visual Resource V1.0 20230420.docx File Note - Database Build Paper V1.0 20220317.pdf File Note A4 Site File - Delegation logs - 20220531.pdf File Note Template V1.0 20220218.docx IRASForm 304658 approved 20211004.pdf Investigator Site File Index 20240531 V10.0.docx PES Treatment Guide for Participants 20240530.pdf Professor Philip Bath CV 20230104.pdf RF1 TA013 Trial Amendment Log.doc Randomisation and blinding File Note V2.0 20220426.pdf Site File front sheet.pdf Site Monitoring Visit Log V2.0 20221229.docx Study SoECAT CRN Final Reauthorised V3.0 20230613.pdf TSC Charter - Signed.pdf Treatment Tick-List for Participant v1.0 20240416 (1).pdf Trial Contact Sheet V3.0 20240404.docx Version Control Table - Scotland V7.0 20240604.docx Version Control Table England Wales and NI V7.0 20240604.docx Trial Manual V6.0 20231212.pdf

UK site training	» Please click here to view superseded documents A.4 - SOP TA008 Trial InitiationV3.5 (1).pdf Attendance at investigator training file note V1.0 20220427.pdf FAQs V7.0 20240820.pdf SIV Slides v9.0 20240606.pdf RF1 TA008 Attendance Investigator Training PhEAST Final v1.0 (1).docx

Information sheets and consent forms	» Please click here to view superseded documents (Scot) Participant Recovered Capacity (re-consent) PIS v4.0 20230307 clean.docx (Scot) Participant consent final V4.0 20230307 clean.docx (Scot) long PIS V6.0 20230307 clean.docx Aphasia Friendly PIS and ICF (Scot) V2.0 20221027 clean.docx Aphasia Friendly PIS and ICF V2.0 20220809 clean.docx Consultee Declaration Form V4.0 clean 20230328.docx Consultee PIS Final V6.0 clean 20230328.docx Consultee Tel Declaration Form Final V3.0 20220513 clean.docx GP letter (Scotland) V3.0 20221027.docx GP letter Final V3.0 20220513 clean.docx Informant Consent Form V3.0 20221219 clean.docx Informant Information Sheet v1.0 20220624 clean.docx Informant Tel Consent Form England and Wales V3.0 20221912 clean.docx Participant Re-consent Final V3.0 20220513 clean.docx Participant consent Final V3.0 20220513 clean.docx Scotland Informant (WA.WG.NR) Consent Form Final V2.0 20230307 clean.docx Scotland Informant (WA.WG.NR) Information Sheet Final v1.020220624 clean.docx Scotland Informant (WA.WG.NR) Tel Consent Form V2.0 20230307 clean.docx Scotland Legal Rep (WA.WG.NR) Consent Form Final v5.0 20230307 clean.docx Scotland Legal Rep (WA.WG.NR) Tel Consent Form V5.0 20230307 clean.docx Scotland Legal rep (WA.WG.NR) Information Sheet Final V 6.0 20230307 clean.docx Scotland Participant Recovered Capacity Re-consent Final v5.0 20230307 clean.docx Long PIS Final V4.0 20220809 clean.docx

Device documents	Supplies Log V1.0 20220308.docx

Sponsor documents	» Please click here to view superseded documents (updated 23 days ago) EOC - CT.pdf (updated 23 days ago)

REC documents	07.01.2022 304658 21-0252 Letter of HRA Approval.pdf 21-SS-0075-Favourable Opinion On Further Information Letter 09-02-2022.pdf 304568 21 EE 0252 Favourable opinion-1.pdf

Substantial amendments	SA-11-24 / (updated 22 hours ago) SA-10-24 / (updated 23 hours ago) SA-09-23 / SA-08-23 / SA-07-23 / SA-06-22 / SA-05-22 / SA-04-22 / SA-03-22 / SA-02-22 / SA-01-22 /

Minor amendments	MA-29-24 / (updated 1 day ago) MA-28-24 / MA-27-24 / MA-26-24 / MA-25-24 / MA-24-24 / MA-23-24 / MA-22-23 / MA-21-23 / MA-20-23 / MA-19-23 / MA-18-23 / MA-17-23 / MA-16-23 / MA-15-23 / MA-14-23 / MA-13-23 / MA-12-23 / MA-11-23 / MA-09-23 / MA-08-23 / MA-07-22 / MA-06-22 / MA-05-22 / MA-04-22 / MA-03-22 / MA-02-22 / MA-01-22 /

Trial working practice documents	» Please click here to view superseded documents WPD 001 Screening and Enrolment Log 20230518 V1.1.pdf WPD 002 Consent 20230518 V1.1.pdf WPD 005 Trial Monitoring 20230518 V2.1.pdf WPD 008 Blinding 20230518 V1.1.pdf WPD 009 Document Preparation V1.0 20221028.pdf WPD 010 Secure Vault Uploads 20230518 V1.1.pdf WPD 012 Randomisation 20230518 V1.1.pdf WPD Log V7.0 20230928.pdf WPD 003 PhEAST Manual Randomisation V1.0 20220216.pdf WPD 004 PhEAST Decontamination of Equipment V1.0 20220216.pdf WPD 011 PhEAST Cognition Sub-study V1.0 20220208 (1).pdf WPD 013 PhEAST SAE Reporting 20230928.pdf

Newsletters	Newsletter - August 2024.pdf Newsletter April 2023.pdf Newsletter August 2022.pdf Newsletter August 2023.pdf Newsletter December 2022.pdf Newsletter February 2023.pdf Newsletter Jan 2024.pdf Newsletter January 2023.pdf Newsletter July 2022.pdf Newsletter July 2023.pdf Newsletter July 2024.pdf Newsletter June 2022.pdf Newsletter June 2023.pdf Newsletter June 2024.pdf Newsletter March 2023.pdf Newsletter May 2023.pdf Newsletter November 2022.pdf Newsletter Oct-Nov 2023.pdf Newsletter October 2022.pdf Newsletter September 2022.pdf Newsletter September 2023.pdf Newsletter September 2024.pdf

Investigator meetings	Investigator Meeting-20230815.mp4 Investigator Meeting-20230911 123211-Meeting Recording.mp4 Investigator Meeting 20220623.mp4 Investigator Meeting 20220903.mp4 Investigator Meeting 20221207.mp4 Investigator Meeting 20230316.mp4 Investigator Meeting 20230426.mp4 Investigator Meeting 20230620.mp4 Investigator Meeting 20230719.mp4 Investigator Meeting Dysphagia Rehabilitation and Pharyngeal Electrical Stimulation 20230518.mp4


Printable CRFs	(updated 307 days ago) Eligibility v1.4 Day 000 v1.3 Day 000 clinical v1.6 Day 000 EQ-5D-5L v1.1 Day 000 IQCODE v1.2 Day 000 cognition v1.1 PES treatment 1 v1.3 PES treatment 2 v1.2 PES treatment 3 v1.2 PES treatment 4 v1.2 PES treatment 5 v1.2 PES treatment 6 v1.3 Day 014 primary outcome v1.6 Day 014 EQ-5D-5L v1.1 Day 014 IQCODE v1.2 Day 014 cognition v1.2 Discharge or died v1.2 Discharge or died EQ-5D-5L v1.1 SWAT v1.2 Serious Adverse Event v1.4 SAE adjudication v1.4 Device deficiency v1.2 Protocol violation v1.1 Protocol deviation v1.0 Withdrawal v1.0 Please log in to download a zip archive of printable CRFs from the supporting site. Participant contact details should be submitted directly online. A printable preview of the contact details form is available here.
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