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

Liver Transplant Clinical Trial

— PREPARE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06036225
• Other study ID #: 21081JB-AS
• Status: Recruiting
• Phase: N/A
• Start date: July 24, 2022
• Est. completion date: September 27, 2024

Study information

• Verified date: December 2023
• Source: Belfast Health and Social Care Trust
• Contact: Suzanne Lester, PhD
• Phone: 07825515905
• Email: slester01[@]qub.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 27, 2024
• Est. primary completion date: July 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Transplant

Intervention

Behavioral:
• Prehabilitation
Remote prehabilitation multi-component.

Locations

Country	Name	City	State
United Kingdom	Queen's University Belfast	Belfast

Sponsors (2)

Lead Sponsor	Collaborator
Belfast Health and Social Care Trust	Queen's University, Belfast

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Acceptability	This will be measured using an acceptability questionnaire.; Min score 0% Max Score 100% Higher values indicate a higher acceptability.	6 months
Secondary	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
Secondary	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