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

• Sponsor: Belfast Health and Social Care Trust (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06036225
• Collaborator: Queen's University, Belfast (Other)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 26.2
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Liver Transplant	Behavioral: Prehabilitation	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Focus groups, experience based co-design and a feasibility studyFocus groups, experience based co-design and a feasibility study
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: PREhabilitation for Patients Awaiting a Liver Transplantation: The Development and Feasibility Testing of a Remote Multicomponent pREhabilitation Intervention: PREPARE
• Actual Study Start Date: Jul 24, 2022
• Anticipated Primary Completion Date: Jul 24, 2024
• Anticipated Study Completion Date: Sep 27, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Receiving the prehabilitation intervention All participants will receive the prehabilitation intervention.	Behavioral: Prehabilitation; Remote prehabilitation multi-component.; Other Names: Remote prehabilitation

Outcome Measures

Primary Outcome Measures

1. Recruitment [6 months]

   It will be presented in percentage form and will be defined by Number of participants active on the list. Number of participants eligible to participate. Number of participants informed about the iPRehab study. Number of participants who were interested in participating. Number of participants recruited. Number of participants interested but didn't recruit and reasons why. Number of participants who own a computer/phone/tablet. Number of participants who can use a computer/phone/tablet independently. Number of participants who need support to use a device. Detail the support required.

2. Adherence [6 months]

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

3. Retention [6 months]

   This will be recorded using percentage and will be defined by Number of participants who completed the baseline assessment. Number of participants who completed the 12-week iPRehab study. Number of participants who completed the assessment 1 week post the iPRehab study. Number of participants who completed the assessment 12 weeks post the iPRehab study. Number of participants who drop out and the reasons

4. Acceptability [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.

Secondary Outcome Measures

1. Physical function [6 months]

   6 minute walk test. This will be recorded in meters covered in the 6 minute duration of the test.

2. Frailty [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Queen's University Belfast	Belfast		United Kingdom

Sponsors and Collaborators

• Belfast Health and Social Care Trust
• Queen's University, Belfast

Investigators

• Principal Investigator: Roger McCorry, Dr, Belfast HSCT

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Belfast Health and Social Care Trust
• ClinicalTrials.gov Identifier: NCT06036225
• Other Study ID Numbers: 21081JB-AS
• First Posted: Sep 13, 2023
• Last Update Posted: Sep 13, 2023
• Last Verified: Sep 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Belfast Health and Social Care Trust: Liver transplant; Liver transplantation; Prehabilitation

Study Results

No Results Posted as of Sep 13, 2023