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

December 13, 2023 updated by: Belfast Health and Social Care Trust

PREhabilitation for Patients Awaiting a Liver Transplantation: The Development and Feasibility Testing of a Remote Multicomponent pREhabilitation Intervention: PREPARE

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Belfast, United Kingdom
        • Recruiting
        • Queen's University Belfast
        • Contact:
        • Sub-Investigator:
          • Suzanne Lester, PhD
        • Principal Investigator:
          • Roger McCorry, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
6 months
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.
6 months
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Belfast Health and Social Care Trust

Collaborators

Queen's University, Belfast

Investigators

  • Principal Investigator: Roger McCorry, Dr, Belfast HSCT

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2022

Primary Completion (Estimated)

July 24, 2024

Study Completion (Estimated)

September 27, 2024

Study Registration Dates

First Submitted

May 3, 2023

First Submitted That Met QC Criteria

September 6, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 21081JB-AS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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