Identifying Perceived Barriers and Facilitators Toward a Liver Transplantation Prehabilitation

NCT ID: NCT04854564

Last Updated: 2023-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

114 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-01

Study Completion Date

2023-04-28

Brief Summary

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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

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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

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Liver Transplant; Complications

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Prehabilitation intervention

Intervention Type BEHAVIORAL

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.

Caregivers of potential liver transplant candidates

They are the primary caregivers for the patients.

Caregiver intervention

Intervention Type BEHAVIORAL

The investigators will provide caregivers with variety of educational resources for patients experiencing ESLD.

Interventions

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Prehabilitation intervention

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.

Intervention Type BEHAVIORAL

Caregiver intervention

The investigators will provide caregivers with variety of educational resources for patients experiencing ESLD.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Caregivers:

* Adult (age≄ 19 years)
* English-speaking
* Provide direct care to LT candidates

Exclusion Criteria

* Inability to communicate verbally in English
* Documentation of cognitive deficits
Minimum Eligible Age

19 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Haiyan Qu

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Haiyan Qu, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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IRB-300007058

Identifier Type: -

Identifier Source: org_study_id

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