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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04854564
Enrollment
114
Registered
2021-04-22
Start date
2021-08-01
Completion date
2023-04-28
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Transplant; Complications

Keywords

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

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).

Interventions

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.

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

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to 74 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Liver frailty index (LFI) scoreFrom baseline through 3 monthsChange 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 monthsChange 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026