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Completed

NCT Number: NCT04854564

Identifying Perceived Barriers and Facilitators Toward a Liver Transplantation Prehabilitation

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.

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Key information

Conditions

Liver Transplant; Complications Digestive System Diseases End Stage Liver Disease Frailty Hepatic Insufficiency Liver Diseases Liver Failure Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

19 year–74 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prehabilitation Intervention

Behavioral

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

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 22, 2021
Registry last updated
May 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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