On this page you will find all relevant documents and resources for setting up and conducting the trial at site.

To help you with this, please find a version control log and index listing all of our documents here. This can be printed out if you wish to create a paper ISF.

Investigator Site File Contents:

Reference Information

eISF Receipt Link opens in a new window

Trial Contacts and Coordination DetailsLink opens in a new window

iRehab Trial SummaryLink opens in a new window

Protocol

ProtocolLink opens in a new window

Information for Participants

Participant Information sheetLink opens in a new window

Consent FormLink opens in a new window

Patient Invitation Poster

Consultant LetterLink opens in a new window

GP LetterLink opens in a new window

Patient Invitation Letter Link opens in a new window

Main Ethics

HRA Approval Link opens in a new window

REC Approval Link opens in a new window

IRAS ApplicationLink opens in a new window

Amendments

Summary of ethical amendmentsLink opens in a new window 

• Substantial Amendment 1

HRA ApprovalLink opens in a new window

REC ApprovalLink opens in a new window

Summary of changes:

Amendment to project timelines due to longer set-up time. Addition of written instructions for participants. Edits to SoECAT to make this site-specific. Minor edits to documents such as questionnaires, PILs, protocol and cover letter for smart watch. Inclusion of trial website screenshots for review. Inclusion of questionnaires for the Process Evaluation.

• Substantial Amendment 2

HRA ApprovalLink opens in a new window

REC ApprovalLink opens in a new window

Summary of changes:

Minor changes to study documents: iRehab Pulse Oximeter Instructions V2.0 02.05.2023, iRehab Interview Script Staff V2.0 02.05.2023, iRehab PIL HCP Interviews V20.03.2023, iRehab 8 Week Questionnaire Initial Letter and Reminder Letter, both V3.0 12.05.2023, iRehab Consent Interview Participant or Team V2.0 17.05.2023

Clarification/updates added throughout around the interview process, addition of Queen's University Belfast as an institution that will be receiving data and have access to identifiable information. Clarity provided on a acceptability/feasibility questionnaire that will be obtained at 8 weeks via an additional third-party database link, phone or post. Documents affected: iRehab PIL V5.0 11.05.2023, iRehab Consent Form V2.0 09.05.2023, iRehab Protocol V5.0 11.05.2023.

• Substantial Amendment 3

HRA Approval 

REC Approval

Summary of changes:

Addition of a participant newsletter emailed to participants where possible or posted to those without an email address by Warwick Clinical Trials Unit. The participant newsletter will be sent once a year [end of 2023, 2024 and 2025] to provide participants feedback about the research.

Addition of instructions on using and setting up BEAM. A tool used when delivering the intervention as part of iRehab.

• Substantial Amendment 4

HRA Approval

REC Approval

Summary of changes:

Addition of four new intervention handouts.

• Non-Substantial Amendment 1: Addition of new trial sites
• Non-Substantial Amendment 2: Addition of new trial sites
• Non-Substantial Amendment 3: Addition of new trial sites
• Non-Substantial Amendment 4: Addition of new trial sites
• Non-Substantial Amendment 5: Addition of new trial sites
• Non-Substantial Amendment 6: Addition of cover letter for postal participants
• Non-Substantial Amendment 7:

Summary of changes:

Amendment to clarify and add additional methods of contact to support in data collection and intervention delivery. Minor typo and grammatical changes made to the PIS, GP and consultant letters. Clarification added to the protocol around clarifying reporting AE/SAEs. Minor change to cover letters to include participants trial number.  

• Non-Substantial Amendment 8: Addition of new trial sites
• Non-Substantial Amendment 9: Minor changes to interview topic guide
• Non-Substantial Amendment 10: Addition of new trial sites
• Non-Substantial Amendment 11: Minor change to mNCA to invoicing process
• Non-Substantial Amendment 12: Change in PI at approved site
• Non-Substantial Amendment 13: Addition of new trial sites
• Non-Substantial Amendment 14: Addition of new trial sites and change in trust name
• Non-Substantial Amendment 15: Addition of a new cover letter for TFAQ and update to sit to stand test instructions
• Non-Substantial Amendment 16: Removal of PI details for existing site
• Non-Substantial Amendment 17: Addition of PI details for existing site
• Non-Substantial Amendment 18: Addition of new trial site
• Non-Substantial Amendment 19: Addition of new trial site
• Non-Substantial Amendment 20: Minor updates to secondary outcome, including cover letter, email and text
• Non-Substantial Amendment 21: Addition of trial sites
• Non-Substantial Amendment 22: Addition of trial site

Site Information and Approvals

Feasibility QuestionnaireLink opens in a new window

Delegation Log Link opens in a new window

Site Training SlidesLink opens in a new window

Site Training Attendance Log Link opens in a new window

Database TrainingLink opens in a new window ILink opens in a new window

Investigator Training Log Link opens in a new window

General Site Information: Guidelines

CRF Completion Guidelines Link opens in a new window

Pre Screening Log Guidance Link opens in a new window

Data Collection

Pre Screening Log Link opens in a new window

1. Screening Form Link opens in a new window

2. Contact Details Form Link opens in a new window

3. Registration Consent Form (Watermarked) Link opens in a new window

4. Co-morbidities Form (Watermarked) Link opens in a new window

5. Readmission Form (Watermarked) Link opens in a new window

6. Protocol Deviation Form (Watermarked) Link opens in a new window

7. File Note (Watermarked) Link opens in a new window

8. Adverse Event Form Link opens in a new window

9. Initial Serious Adverse Event Form Link opens in a new window

10. Serious Adverse Event Continuation Form Link opens in a new window

11. Follow-Up Serious Adverse Event Form Link opens in a new window

12. Discontinued Treatment Form (Watermarked) Link opens in a new window

13. Withdrawal Form (Watermarked) Link opens in a new window

14. Notification of Death Form (Watermarked) Link opens in a new window

15. Serious Adverse Event Evaluation Form Link opens in a new window