Liver Transplant; ComplicationsNCT04854564
Identifying Perceived Barriers and Facilitators Toward a Liver Transplantation Prehabilitation
An observational study of Liver Transplant; Complications, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to formally identify patient and caregiver perceived needs, barriers, and facilitators to inform the development of a home-based multimodal prehabilitation program for potential LT candidates. Read more about this study
- Who is it for?
- Ages 19 to 74 years
- Conditions the study is for
- Liver Transplant; Complications
- What is being tested?
- Prehabilitation intervention and Caregiver intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 114 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2021to 28 Apr 2023
- Phase
- Observational
- 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 19 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will include adult, all gender, and all race patients with end-stage liver disease (ESLD) who have been assigned to the liver transplant (LT) waitlist. Nationally, the median age of LT candidates is 57 (48, 63) during 2014 to 2018. UAB Liver Transplant Center technically does not limit patients over 75 years old for LT (i.e., age alone is not an absolute contraindication), but typically as patients age they have less physiologic reserve to tolerate transplant so they must have a better pre-transplant functional status than a younger patient in order to have a good outcome post-transplant. Participants will be identified and recruited from the UAB Liver Transplant Center using a purposive maximum variation sampling approach in terms of age, gender, race, and severity of ESLD.
Who may be able to join
- Liver transplant (LT) candidates are:
- Adult ESLD patients (age=19-74 years) who are assigned to the LT waitlist
- English-speaking
- No contraindication to moderate intensity physical activities
- Physician clearance for participation in moderate intensity physical activities
- No history of dementia or organic brain syndrome
Show all 10Show fewer
- Caregivers:
- Adult (age≥ 19 years)
- English-speaking
- Provide direct care to LT candidates
Who cannot join
- Inability to communicate verbally in English
- Documentation of cognitive deficits
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Identifying Perceived Barriers and Facilitators to Inform the Development of a Liver Transplantation Prehabilitation Intervention
The purpose of this study is to formally identify patient and caregiver perceived needs, barriers, and facilitators to inform the development of a home-based multimodal prehabilitation program for potential LT candidates.
Read the detailed description
After being informed about the study and potential risks, all participants (patients and caregivers) giving written informed consent will be invited to participate in one of three research activities: interviews (n=10), nominal group technique meetings (n=64), or card-sorting and rating survey (n=40).
- Conditions
- Liver Transplant; Complications
- Being tested
- Prehabilitation intervention, Caregiver intervention
- Keywords
- end-stage liver disease (ESLD), frailty, prehabilitation
- Medical subject headings
- End Stage Liver Disease, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation interventionBehavioural
The investigators will identify participants' perceived important information to develop a prehabilitation intervention in this study. Prehabilitation intervention consisting of physical activities, nutrition, and stress management.
Caregiver interventionBehavioural
The investigators will provide caregivers with variety of educational resources for patients experiencing ESLD.
| Study group | Role | What they receive |
|---|---|---|
| End-stage liver disease (ESLD) patients | These potential liver transplant candidates are patients with end-stage liver disease (ESLD) who have been assigned to the liver transplant waitlist. Receives: Behavioral: Prehabilitation intervention | |
| Caregivers of potential liver transplant candidates | They are the primary caregivers for the patients. Receives: Behavioral: Caregiver intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver frailty index (LFI) score
Change from baseline in liver frailty index score at 3 months; the higher LFI scores indicate a higher degree of frailty. LFI<3.2: robust, LFI=3.2-4.4: prefrail, LFI>=4.5: Frail.
Measured: From baseline through 3 months
Caregiver burden measured using Zarit Burden Interview short form (ZBI-12)
Change from baseline in the total ZBI-12 scores at 3 months. The total ZBI-12 score is the summation of 12 items, ranging from 0 to 48; the higher scores indicate higher burden (0-10:no to mild burden; 10-20: mild to moderate burden), and >20: high burden.
Measured: From baseline through 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start1 Aug 2021
- Primary completion25 Apr 2023
- Study completion28 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haiyan Qu, University of Alabama at Birmingham
- Investigators
- Haiyan Qu, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04854564
- Sponsor's protocol ID
- IRB-300007058
- Status last verified
- Apr 2023
- First submitted
- 13 Apr 2021
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The nominal group technique meeting data will be shared in an aggregate level by group. The card-sorting data and rating data will be shared in an aggregate level by participant type (patient vs caregiver).
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Perceived Barriers and Facilitators to Inform the Development of a Liver Transplantation Prehabilitation Intervention
- ClinicalTrials.gov ID
- NCT04854564
- Acronym / sponsor ID
- IRB-300007058
- Conditions
- Liver Transplant; Complications
- Keywords
- end-stage liver disease (ESLD), frailty, prehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 25 Apr 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 22 Apr 2021 (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.
The purpose of this study is to formally identify patient and caregiver perceived needs, barriers, and facilitators to inform the development of a home-based multimodal prehabilitation program for potential LT candidates.
Detailed description
After being informed about the study and potential risks, all participants (patients and caregivers) giving written informed consent will be invited to participate in one of three research activities: interviews (n=10), nominal group technique meetings (n=64), or card-sorting and rating survey (n=40).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| End-stage liver disease (ESLD) patients | – | Behavioral: Prehabilitation interventionThese potential liver transplant candidates are patients with end-stage liver disease (ESLD) who have been assigned to the liver transplant waitlist. |
| Caregivers of potential liver transplant candidates | – | Behavioral: Caregiver interventionThey are the primary caregivers for the patients. |
Who may qualify
- Ages
- 19 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include adult, all gender, and all race patients with end-stage liver disease (ESLD) who have been assigned to the liver transplant (LT) waitlist. Nationally, the median age of LT candidates is 57 (48, 63) during 2014 to 2018. UAB Liver Transplant Center technically does not limit patients over 75 years old for LT (i.e., age alone is not an absolute contraindication), but typically as patients age they have less physiologic reserve to tolerate transplant so they must have a better pre-transplant functional status than a younger patient in order to have a good outcome post-transplant. Participants will be identified and recruited from the UAB Liver Transplant Center using a purposive maximum variation sampling approach in terms of age, gender, race, and severity of ESLD.
Key inclusion criteria (10 listed)
- Adult ESLD patients (age=19-74 years) who are assigned to the LT waitlist
- English-speaking
- No contraindication to moderate intensity physical activities
- Physician clearance for participation in moderate intensity physical activities
- No history of dementia or organic brain syndrome
Key exclusion criteria (2 listed)
- Inability to communicate verbally in English
- Documentation of cognitive deficits
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 |
|---|---|---|
| Prehabilitation interventionThe investigators will identify participants' perceived important information to develop a prehabilitation intervention in this study. Prehabilitation intervention consisting of physical activities, nutrition, and stress management. | Behavioural | End-stage liver disease (ESLD) patients |
| Caregiver interventionThe investigators will provide caregivers with variety of educational resources for patients experiencing ESLD. | Behavioural | Caregivers of potential liver transplant candidates |
Primary outcome
Liver frailty index (LFI) score
Time frame: From baseline through 3 months
Change from baseline in liver frailty index score at 3 months; the higher LFI scores indicate a higher degree of frailty. LFI<3.2: robust, LFI=3.2-4.4: prefrail, LFI>=4.5: Frail.
Caregiver burden measured using Zarit Burden Interview short form (ZBI-12)
Time frame: From baseline through 3 months
Change from baseline in the total ZBI-12 scores at 3 months. The total ZBI-12 score is the summation of 12 items, ranging from 0 to 48; the higher scores indicate higher burden (0-10:no to mild burden; 10-20: mild to moderate burden), and >20: high burden.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Individual participant dataSharing planned: No. The nominal group technique meeting data will be shared in an aggregate level by group. The card-sorting data and rating data will be shared in an aggregate level by participant type (patient vs caregiver).
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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.
Haiyan Qu, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant; Complications, run by University of Alabama at Birmingham at 1 site in United States.
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 10 inclusion and 2 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: finished, as of the sponsor's last update on 1 May 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 States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver frailty index (LFI) score (time frame: From baseline through 3 months). The study lists 2 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 1 May 2023.