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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04854564
Other study ID # IRB-300007058
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2021
Est. completion date April 28, 2023

Study information

Verified date April 2023
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 114
Est. completion date April 28, 2023
Est. primary completion date April 25, 2023
Accepts healthy volunteers No
Gender All
Age group 19 Years to 74 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama

Sponsors (1)

Lead Sponsor Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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