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Clinical Trials/NCT04854564
NCT04854564CompletedNot Applicable

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

University of Alabama at Birmingham1 site in 1 country114 target enrollmentStarted: August 1, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
114
Locations
1
Primary Endpoint
Liver frailty index (LFI) score

Study Overview

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).

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Eligibility Criteria

Ages
19 Years to 74 Years (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Liver frailty index (LFI) score

Time Frame: 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)

Time Frame: 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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Haiyan Qu

Associate Professor

University of Alabama at Birmingham

Study Sites (1)

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