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

NCT06036225 | Unknown DMC

• 1 other identifier: 21081JB-AS
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Liver Transplant

Keywords

Liver transplant; Liver transplantation; Prehabilitation

Outcome Measures

Primary Outcomes (4)

• Recruitment

  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.

  6 months

• Adherence

  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.

  6 months

• Retention

  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.

  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 Outcomes (2)

• Physical function

  6 months

• Frailty

  6 months

Study Arms (1)

Receiving the prehabilitation intervention

EXPERIMENTAL

All participants will receive the prehabilitation intervention.

Behavioral: Prehabilitation

Interventions

Prehabilitation BEHAVIORAL

Remote prehabilitation multi-component.

Also known as: Remote prehabilitation

Receiving the prehabilitation intervention

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• on the transplant waiting list
• grade 3 below for encephalopathy

You may not qualify if:

• grade 4 above encephalopathy
• Known adverse reaction to exercise
• New stroke
• lacks capacity to consent

Sponsors & Collaborators

• Belfast Health and Social Care Trust: lead
• Queen's University, Belfast: collaborator

Study Sites (1)

Queen's University Belfast

Belfast, United Kingdom

RECRUITING

MeSH Terms

Interventions

Preoperative Exercise

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Roger McCorry, Dr

  Belfast HSCT

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Suzanne Lester, PhD

CONTACT

07825515905; slester01@qub.ac.uk

Judy Bradly, Prof

CONTACT

judy.bradley@qub.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: September 13, 2023
• Study Start: July 24, 2022
• Primary Completion: July 24, 2024
• Study Completion: September 27, 2024
• Last Updated: December 20, 2023

Record last verified: 2023-12

Locations

GB (1)