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

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.

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

Conditions
-----------------
Liver Transplant

Intervention / Treatment
-----------------
* Behavioral: Prehabilitation


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Focus groups, experience based co-design and a feasibility study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Receiving the prehabilitation intervention<br>All participants will receive the prehabilitation intervention. | Behavioral: Prehabilitation<br>* Remote prehabilitation multi-component.<br>* Other names: Remote prehabilitation;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment | 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. Min score 0% Max Score 100% Higher values indicate a higher recruitment rate. | 6 months | 
| Adherence | 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. Min score 0% Max Score 100% Higher values indicate a higher adherence rate. | 6 months | 
| Retention | 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 Min score 0% Max Score 100% Higher values indicate a higher retention rate. | 6 months | 
| Acceptability | 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 |
| --- | --- | --- |
| Physical function | 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 | 
| Frailty | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver transplant, Liver transplantation, Prehabilitation