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Clinical Trials/NCT06036225
NCT06036225RecruitingNot Applicable

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

Belfast Health and Social Care Trust1 site in 1 country20 target enrollmentStarted: July 24, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
20
Locations
1
Primary Endpoint
Recruitment

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
16 Years to — (Child, Adult, Older Adult)
Sex
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

Arms & Interventions

Receiving the prehabilitation intervention

Experimental

All participants will receive the prehabilitation intervention.

Intervention: Prehabilitation (Behavioral)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Physical function(6 months)
  • Frailty(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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