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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06036225
Acronym
PREPARE
Enrollment
20
Registered
2023-09-13
Start date
2022-07-24
Completion date
2024-09-27
Last updated
2023-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Transplant

Keywords

Liver transplant, Liver transplantation, Prehabilitation

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.

Interventions

BEHAVIORALPrehabilitation

Remote prehabilitation multi-component.

Sponsors

Queen's University, Belfast
CollaboratorOTHER
Belfast Health and Social Care Trust
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Focus groups, experience based co-design and a feasibility study

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Recruitment6 monthsIt 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.
Adherence6 monthsThis 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.
Retention6 monthsThis 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.
Acceptability6 monthsThis will be measured using an acceptability questionnaire. Min score 0% Max Score 100% Higher values indicate a higher acceptability.

Secondary

MeasureTime frameDescription
Physical function6 months6 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.
Frailty6 monthsThe 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.

Countries

United Kingdom

Contacts

Primary ContactSuzanne Lester, PhD
slester01@qub.ac.uk07825515905
Backup ContactJudy Bradly, Prof
judy.bradley@qub.ac.uk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026