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

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

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
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 : July 24, 2022
Estimated Primary Completion Date : July 24, 2024
Estimated Study Completion Date : September 27, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Receiving the prehabilitation intervention
All participants will receive the prehabilitation intervention.
 Behavioral: Prehabilitation
Remote prehabilitation multi-component.
Other Name: Remote prehabilitation


Outcome Measures
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Primary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. 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.



Secondary Outcome Measures :
  1. 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.


  2. 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.



Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06036225


Contacts
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Contact: Suzanne Lester, PhD 07825515905 slester01@qub.ac.uk
Contact: Judy Bradly, Prof judy.bradley@qub.ac.uk

Locations
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United Kingdom
Queen's University Belfast Recruiting
Belfast, United Kingdom
Contact: Judy Bradley, Prof       judy.bradley@qub.ac.uk   
Sub-Investigator: Suzanne Lester, PhD         
Principal Investigator: Roger McCorry, Dr         
Sponsors and Collaborators
Belfast Health and Social Care Trust
Queen's University, Belfast
Investigators
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Principal Investigator: Roger McCorry, Dr Belfast HSCT
More Information
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Responsible Party: Belfast Health and Social Care Trust
ClinicalTrials.gov Identifier: NCT06036225    
Other Study ID Numbers: 21081JB-AS
First Posted: September 13, 2023    Key Record Dates
Last Update Posted: December 20, 2023
Last Verified: December 2023

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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