PREPARE- Prehabilitation for Patients Awaiting Liver Transplantation: Feasibility and Acceptability Testing. (PREPARE)

• ClinicalTrials.gov Identifier: NCT06036225
• Recruitment Status: Recruiting
• First Posted: September 13, 2023
• Last Update Posted: December 20, 2023
• Sponsor: Belfast Health and Social Care Trust
• Collaborator: Queen's University, Belfast
• Information provided by (Responsible Party): Belfast Health and Social Care Trust

Tracking Information

• First Submitted Date: May 3, 2023
• First Posted Date: September 13, 2023
• Last Update Posted Date: December 20, 2023
• Actual Study Start Date: July 24, 2022
• Estimated Primary Completion Date: July 24, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 13, 2023)

• Recruitment [ Time Frame: 6 months ]
  It will be presented in percentage form and will be defined by

  1. Number of participants active on the list.
  2. Number of participants eligible to participate.
  3. Number of participants informed about the iPRehab study.
  4. Number of participants who were interested in participating.
  5. Number of participants recruited.
  6. Number of participants interested but didn't recruit and reasons why.
  7. Number of participants who own a computer/phone/tablet.
  8. Number of participants who can use a computer/phone/tablet independently.
  9. Number of participants who need support to use a device. Detail the support required.

  Min score 0% Max Score 100% Higher values indicate a higher recruitment rate.
• Adherence [ Time Frame: 6 months ]
  This will be recorded using percentage and will be defined by

  1. Number of participants who attended 1:1 sessions.
  2. Number of participants who attended the group exercise classes using a class log.
  3. Number of participants who attend the online monthly peer support sessions while active on the liver transplantation waiting list.
  4. Number of participants who accessed the website/web app.
  5. Which sections of the website/web app are utilised and the number of participants who access each section.
  6. Number of participants who wear the activity tracker and report weekly step count.

  Min score 0% Max Score 100% Higher values indicate a higher adherence rate.
• Retention [ Time Frame: 6 months ]
  This will be recorded using percentage and will be defined by

  1. Number of participants who completed the baseline assessment.
  2. Number of participants who completed the 12-week iPRehab study.
  3. Number of participants who completed the assessment 1 week post the iPRehab study.
  4. Number of participants who completed the assessment 12 weeks post the iPRehab study.
  5. Number of participants who drop out and the reasons

  Min score 0% Max Score 100% Higher values indicate a higher retention rate.
• Acceptability [ Time Frame: 6 months ]
  This will be measured using an acceptability questionnaire. Min score 0% Max Score 100% Higher values indicate a higher acceptability.

Original Primary Outcome Measures (submitted: September 6, 2023)

• Recruitment [ Time Frame: 6 months ]
  It will be presented in percentage form and will be defined by

  1. Number of participants active on the list.
  2. Number of participants eligible to participate.
  3. Number of participants informed about the iPRehab study.
  4. Number of participants who were interested in participating.
  5. Number of participants recruited.
  6. Number of participants interested but didn't recruit and reasons why.
  7. Number of participants who own a computer/phone/tablet.
  8. Number of participants who can use a computer/phone/tablet independently.
  9. Number of participants who need support to use a device. Detail the support required.
• Adherence [ Time Frame: 6 months ]
  This will be recorded using percentage and will be defined by

  1. Number of participants who attended 1:1 sessions.
  2. Number of participants who attended the group exercise classes using a class log.
  3. Number of participants who attend the online monthly peer support sessions while active on the liver transplantation waiting list.
  4. Number of participants who accessed the website/web app.
  5. Which sections of the website/web app are utilised and the number of participants who access each section.
  6. Number of participants who wear the activity tracker and report weekly step count.
• Retention [ Time Frame: 6 months ]
  This will be recorded using percentage and will be defined by

  1. Number of participants who completed the baseline assessment.
  2. Number of participants who completed the 12-week iPRehab study.
  3. Number of participants who completed the assessment 1 week post the iPRehab study.
  4. Number of participants who completed the assessment 12 weeks post the iPRehab study.
  5. Number of participants who drop out and the reasons
• Acceptability [ Time Frame: 6 months ]
  This will be measured using an acceptability questionnaire known as Theoretical Framework Acceptability Questionnaire (TFAQ) (Sekhon et al 2022) and followed up with a short interview to understand the extremes of acceptability.

Current Secondary Outcome Measures (submitted: December 13, 2023)

• Physical function [ Time Frame: 6 months ]
  6 minute walk test. This will be recorded in meters covered in the 6 minute duration of the test. Min score 0 Max Score 1000 Higher values indicate better physical function.
• Frailty [ Time Frame: 6 months ]
  The Liver frailty index. This index will determine the degree of frailty patients present while awaiting liver transplantation. This scale determines if the patients are frail, pre-frail or robust. Min score 1 Max Score 7 Higher values indicate a higher degree of frailty.

Original Secondary Outcome Measures (submitted: September 6, 2023)

• Physical function [ Time Frame: 6 months ]
  6 minute walk test. This will be recorded in meters covered in the 6 minute duration of the test.
• Frailty [ Time Frame: 6 months ]
  The Liver frailty index. This index will determine the degree of frailty patients present while awaiting liver transplantation. This scale determines if the patients are frail, pre-frail or robust. Min score 1 Max Score 7 Higher values indicate a higher degree of frailty.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: PREPARE- Prehabilitation for Patients Awaiting Liver Transplantation: Feasibility and Acceptability Testing.
• Official Title: PREhabilitation for Patients Awaiting a Liver Transplantation: The Development and Feasibility Testing of a Remote Multicomponent pREhabilitation Intervention: PREPARE

Brief Summary

This is a study developing a prehabilitation intervention and then testing the acceptability and feasibility of the intervention.

Start date Aug 2022 for Focus groups and Feb 2023 Co-design workshops and feasibility study date pending

Detailed Description

This study is using focus groups and experience based co-design workshops to co-design a remote multicomponent prehabilitation intervention for patients awaiting liver transplantation.

Once the intervention is developed it will then be tested for acceptability and feasibility with the liver transplantation cohort in Belfast Northern Ireland.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Focus groups, experience based co-design and a feasibility study

Masking: None (Open Label)
Primary Purpose: Supportive Care

• Condition: Liver Transplant

Intervention

Behavioral: Prehabilitation

Remote prehabilitation multi-component.

Other Name: Remote prehabilitation

Study Arms

Experimental: Receiving the prehabilitation intervention

All participants will receive the prehabilitation intervention.

Intervention: Behavioral: Prehabilitation

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 6, 2023): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 27, 2024
• Estimated Primary Completion Date: July 24, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• on the transplant waiting list
• grade 3 below for encephalopathy

Exclusion Criteria:

• grade 4 above encephalopathy
• Known adverse reaction to exercise
• New stroke
• lacks capacity to consent

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 16 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Suzanne Lester, PhD; 07825515905; slester01@qub.ac.uk

Contact: Judy Bradly, Prof; judy.bradley@qub.ac.uk

• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT06036225
• Other Study ID Numbers: 21081JB-AS
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Belfast Health and Social Care Trust
• Original Responsible Party: Same as current
• Current Study Sponsor: Belfast Health and Social Care Trust
• Original Study Sponsor: Same as current
• Collaborators: Queen's University, Belfast

Investigators

• Principal Investigator: Roger McCorry, Dr; Belfast HSCT

• PRS Account: Belfast Health and Social Care Trust
• Verification Date: December 2023