Identifying Perceived Barriers and Facilitators Toward a Liver Transplantation Prehabilitation

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Recruiting

CT.gov ID

NCT04854564

Collaborator

(none)

114

Enrollment

Location

Anticipated Duration (Months)

8.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Transplant; Complications	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 Design

Study Type:

Observational

Anticipated Enrollment :

114 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 1, 2021

Actual Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Aug 31, 2022

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 74 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Haiyan Qu, Associate Professor, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT04854564

Other Study ID Numbers:

IRB-300007058

First Posted:

Apr 22, 2021

Last Update Posted:

Jul 5, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Haiyan Qu, Associate Professor, University of Alabama at Birmingham

end-stage liver disease (ESLD)

frailty

prehabilitation

Study Results

No Results Posted as of Jul 5, 2022