Identifying Perceived Barriers and Facilitators Toward a Liver Transplantation Prehabilitation

Completed

• Conditions: Liver Transplant; Complications
• Interventions: Behavioral: Prehabilitation intervention; Behavioral: Caregiver intervention

• Registration Number: NCT04854564
• Lead Sponsor: University of Alabama at Birmingham

Brief 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.

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).

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2021-04-13
• Study First Submitted QC: 2021-04-19
• Study First Posted: 2021-04-22
• Study Start: 2021-08-01
• Status Verified: 2023-04
• Primary Completion: 2023-04-25
• Study Completion: 2023-04-28
• Last Update Submitted: 2023-04-28
• Last Update Posted: 2023-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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

Read More

Exclusion Criteria

• Inability to communicate verbally in English
• Documentation of cognitive deficits

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
End-stage liver disease (ESLD) patients	Prehabilitation intervention	These 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	Caregiver intervention	They are the primary caregivers for the patients.

Primary Outcome Measures

Name	Time	Method
Liver frailty index (LFI) score	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)	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.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States