Trial documents

Approved protocol

• 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

• 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

• 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

• (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

• EOC - CT.pdf

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 /
• SA-10-24 /
• 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 /
• 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

• WPD Log V8.0 20241212.docx   (updated 8 days ago)
• WPD 001 PhEAST Screening and Enrolment Log V2.0 20241212.docx   (updated 9 days ago)
• WPD 002 PhEAST Consent V2.0 20241212.docx   (updated 9 days ago)
• WPD 003 PhEAST Manual Randomisation V1.0 20220216.pdf
• WPD 004 PhEAST Decontamination of Equipment V2.0 20241212.docx   (updated 9 days ago)
• WPD 005 PhEAST Trial Monitoring V3.0 20241212.docx   (updated 9 days ago)
• WPD 006 PhEAST Central Follow ups V2.0 20241212.docx   (updated 9 days ago)
• WPD 008 PhEAST Blinding V2.0 20241212.docx   (updated 8 days ago)
• WPD 009 PhEAST Document Prep and Upload V2.0 20241212.docx   (updated 8 days ago)
• WPD 010 PhEAST Secure Vault Uploads V2.0 20241212.docx   (updated 8 days ago)
• WPD 011 PhEAST Cognition Sub-study V2.0 20241212.docx   (updated 8 days ago)
• WPD 012 PhEAST Randomisation V2.0 20241212.docx   (updated 8 days ago)
• WPD 013 PhEAST SAE Reporting V2.0 20241212.docx   (updated 8 days ago)
• WPD 014 PhEAST Closedown v2.0 20241212.docx   (updated 8 days ago)

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

• Eligibility v1.5
• 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 v1.4
• PES treatment 2 v1.3
• PES treatment 3 v1.3
• PES treatment 4 v1.3
• PES treatment 5 v1.3
• PES treatment 6 v1.4
• 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 v1.2
• Protocol deviation v1.0
• Withdrawal v1.0