Identifying Perceived Barriers and Facilitators Toward a Liver Transplantation Prehabilitation

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.

Study Overview

• Status: Completed
• Conditions: Liver Transplant; Complications
• Intervention / Treatment: Behavioral: Prehabilitation intervention; Behavioral: Caregiver intervention

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 Type: Observational
• Enrollment (Actual): 114

Contacts and Locations

• Study Contact: Name: Haiyan Qu, PhD; Phone Number: (205) 934-6101; Email: haiyanqu@uabmc.edu
• Study Contact Backup: Name: Rhiannon D Reed, DrPH; Phone Number: (205) 996-2894; Email: rdeierhoi@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.
Caregivers of potential liver transplant candidates; They are the primary caregivers for the patients.	Behavioral: Caregiver intervention; The investigators will provide caregivers with variety of educational resources for patients experiencing ESLD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Haiyan Qu, PhD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): April 25, 2023
• Study Completion (Actual): April 28, 2023

Study Registration Dates

• First Submitted: April 13, 2021
• First Submitted That Met QC Criteria: April 19, 2021
• First Posted (Actual): April 22, 2021

Study Record Updates

• Last Update Posted (Actual): May 1, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: frailty; prehabilitation; end-stage liver disease (ESLD)
• Other Study ID Numbers: IRB-300007058

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No