Identifying Perceived Barriers and Facilitators Toward a Liver Transplantation Prehabilitation

NCT04854564 | Completed

• 1 other identifier: IRB-300007058
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplant; Complications

Keywords

end-stage liver disease (ESLD); frailty; prehabilitation

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

Caregivers of potential liver transplant candidates

They are the primary caregivers for the patients.

Behavioral: Caregiver intervention

Interventions

Prehabilitation intervention 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.

End-stage liver disease (ESLD) patients

Caregiver intervention BEHAVIORAL

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

Caregivers of potential liver transplant candidates

Eligibility Criteria

• Age: 19 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

End Stage Liver Disease; Frailty

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Haiyan Qu, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 22, 2021
• Study Start: August 1, 2021
• Primary Completion: April 25, 2023
• Study Completion: April 28, 2023
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)