Identifying Perceived Barriers and Facilitators Toward a Liver Transplantation Prehabilitation

Liver Transplant; Complications Clinical Trial

Official title:

Identifying Perceived Barriers and Facilitators to Inform the Development of a Liver Transplantation Prehabilitation Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04854564
• Other study ID #: IRB-300007058
• Status: Completed
• Start date: August 1, 2021
• Est. completion date: April 28, 2023

Study information

• Verified date: April 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: April 28, 2023
• Est. primary completion date: April 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Transplant; Complications

Intervention

Behavioral:
• 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.
• Caregiver intervention
The investigators will provide caregivers with variety of educational resources for patients experiencing ESLD.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From baseline through 3 months
Primary	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.	From baseline through 3 months