Clinical trial NCT04854564: Identifying Perceived Barriers and Facilitators Toward a Liver Transplantation Prehabilitation
Official title: Identifying Perceived Barriers and Facilitators to Inform the Development of a Liver Transplantation Prehabilitation Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Transplant; Complications
Keywords: end-stage liver disease (ESLD)
frailty
prehabilitation
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2021-04-22
Enrollment: 114
Sex: ALL
Minimum age (years): 19
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Liver frailty index (LFI) score
timeFrame: From baseline through 3 months
measure: Caregiver burden measured using Zarit Burden Interview short form (ZBI-12)
timeFrame: From baseline through 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Haiyan Qu, PhD
role: PRINCIPAL_INVESTIGATOR
References: