PREPARE :PREhabilitation for Patients Awaiting liveR transplantation

  • Research type

    Research Study

  • Full title

    PREhabilitation for Patients Awaiting liveR transplantation: development and feasibility testing of a remote multicomponent prEhabilitation intervention: PREPARE

  • IRAS ID

    299961

  • Contact name

    Judy Bradley

  • Contact email

    judy.bradley@qub.ac.uk

  • Sponsor organisation

    Belfast Health and Social Care Trust

  • Clinicaltrials.gov Identifier

    Awaited , Northern Ireland Clinical Research Network

  • Duration of Study in the UK

    3 years, 0 months, 0 days

  • Research summary

    Summary of Research
    BACKGROUND:
    End stage liver disease (ESLD) develops as a consequence of long-term, continuous damage and can result from many different causes leading to impaired liver function. Patients with cirrhosis often notice that they lose weight from their muscles, which in turn makes them feel weaker. This presentation is often referred to as deconditioned. Presenting as deconditioned before surgery in patients with ESLD who are awaiting liver transplantation may result in poorer recovery afterwards.
    AIM: The aim of this project is to develop and test a rehabilitation programme (prehabilitation)to patients with end stage liver disease awaiting a liver transplantation.
    METHODS:
    1. Focus Groups- Discussions with patients, caregivers and clinicians, to discuss their thoughts and opinions on what a remote multicomponent prehabilitation intervention should look like. This will include opinions on the barriers and facilitators to participating in such an intervention, how it should run, what components should be included, and what outcomes are important to patients and clinicians in deciding whether the intervention is helpful.
    2. Experienced based co-design workshops- This is where we will work together with patients, caregivers, and clinicians, to develop the remote multicomponent prehabilitation intervention using the results of the focus groups.
    4. Feasibility study- This is a method of testing the intervention that is developed to decide whether it is safe, well-tolerated, acceptable to patients, and practical to deliver.
    PRIMARY OUTCOME:
    To develop a co-designed prehabilitation intervention (programme)and collect the feasibility data for patients awaiting liver transplantation.

    Summary of Results
    We reviewed 107 research papers to decide what should be included in a prehabilitation programme, such as exercise, mental health, nutrition, breathing support, and relaxation. Focus groups with patients, families, and clinicians helped shape the programme based on the literature. A co-design workshop finalised delivery. The final version included weekly one-to-one online sessions for exercise and symptom management and psychological support, monthly peer support, and education resource support. Additional support included access to a group exercise and nutrition classes weekly, exercise videos (available any time), and a website with educational materials. The programme was developed with the iRehab trial team and adapted for liver transplant patients. The iPRehab intervention was feasible and patients and clinicians found the programme acceptable. Patients reported feeling less anxious and less depressed, gained confidence in exercising, and valued peer and clinical support. The programme also showed encouraging trends in improvements in physical function and activity levels. Out of 27 patients, 7 did not complete the programme (due to personal choice, transplantation, or death).
    Conclusion
    A remote multicomponent prehabilitation programme for people awaiting liver transplant is both acceptable and feasible. With small adjustments, it is ready to be tested in a larger trial to measure its full benefits.

  • REC name

    HSC REC B

  • REC reference

    22/NI/0045

  • Date of REC Opinion

    8 Apr 2022

  • REC opinion

    Further Information Favourable Opinion