Liver TransplantPREPARENCT06036225
PREPARE- Prehabilitation for Patients Awaiting Liver Transplantation: Feasibility and Acceptability Testing.
A study testing Prehabilitation in people with Liver Transplant, run by Belfast Health and Social Care Trust at 1 site in United Kingdom.
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 Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Liver Transplant
- What is being tested?
- Prehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Jul 2022to 27 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- on the transplant waiting list
- grade 3 below for encephalopathy
Who cannot join
- grade 4 above encephalopathy
- Known adverse reaction to exercise
- New stroke
- lacks capacity to consent
Trial locations and contacts
1 site in 1 country.
Judy Bradly, Prof contact
United Kingdom1 site, 1 recruiting
- Recruiting
Queen's University Belfast
Belfast
Judy Bradley, Prof, judy.bradley@qub.ac.uk
Suzanne Lester, PhD
About this study
Official title: PREhabilitation for Patients Awaiting a Liver Transplantation: The Development and Feasibility Testing of a Remote Multicomponent pREhabilitation Intervention: PREPARE
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
Read the 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.
- Conditions
- Liver Transplant
- Being tested
- Prehabilitation
- Keywords
- Liver transplant, Liver transplantation, Prehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationBehavioural
Also called Remote prehabilitation
Remote prehabilitation multi-component.
| Study group | Role | What they receive |
|---|---|---|
| Receiving the prehabilitation intervention | Experimental | All participants will receive the prehabilitation intervention. Receives: Behavioral: Prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 months
Acceptability
This will be measured using an acceptability questionnaire.
Min score 0% Max Score 100% Higher values indicate a higher acceptability.
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start24 Jul 2022
- Primary completion24 Jul 2024 (estimated)
- Study completion27 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Focus groups, experience based co-design and a feasibility study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Belfast Health and Social Care Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Queen's University, Belfast
- Responsible party
- Sponsor
- Investigators
- Roger McCorry, Dr, Principal investigator, Belfast HSCT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036225
- Sponsor's protocol ID
- 21081JB-AS
- Acronym
- PREPARE
- Status last verified
- Dec 2023
- First submitted
- 3 May 2023
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREhabilitation for Patients Awaiting a Liver Transplantation: The Development and Feasibility Testing of a Remote Multicomponent pREhabilitation Intervention: PREPARE
- ClinicalTrials.gov ID
- NCT06036225
- Acronym / sponsor ID
- PREPARE / 21081JB-AS
- Conditions
- Liver Transplant
- Keywords
- Liver transplant, Liver transplantation, Prehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Belfast Health and Social Care TrustUniversity, hospital or other
- Collaborators
- Queen's University, Belfast
- Study start
- 24 Jul 2022 (actual)
- Primary completion
- 24 Jul 2024 (estimated)
- Study completion
- 27 Sep 2024 (estimated)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Focus groups, experience based co-design and a feasibility study
| Arm | Type | Receives |
|---|---|---|
| Receiving the prehabilitation intervention | Experimental | Behavioral: PrehabilitationAll participants will receive the prehabilitation intervention. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- on the transplant waiting list
- grade 3 below for encephalopathy
Key exclusion criteria (4 listed)
- grade 4 above encephalopathy
- Known adverse reaction to exercise
- New stroke
- lacks capacity to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrehabilitationAlso: Remote prehabilitationRemote prehabilitation multi-component. | Behavioural | Receiving the prehabilitation intervention |
Primary outcome
Recruitment
Time frame: 6 months
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.
Adherence
Time frame: 6 months
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.
Retention
Time frame: 6 months
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.
Acceptability
Time frame: 6 months
This will be measured using an acceptability questionnaire. Min score 0% Max Score 100% Higher values indicate a higher acceptability.
2 secondary outcomes
Physical function
Time frame: 6 months
Frailty
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judy Bradly, Prof contact
Roger McCorry, Dr principal investigator
Belfast HSCT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation in people with Liver Transplant, run by Belfast Health and Social Care Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suzanne Lester, PhD (07825515905, slester01@qub.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.