Functional Assessment in Liver Transplantation

Recruiting

• Conditions: Cirrhosis; End Stage Liver Disease

• Registration Number: NCT03870568
• Lead Sponsor: Baylor Research Institute

Brief Summary

In order to ensure the equity of the liver allocation process, it is important to create objective, scientifically validated markers of frailty in patients with end-stage liver disease that accurately predict patient outcomes. Many measures have been developed to assess this clinical state in elderly patients, but none have been applied to patients with cirrhosis, a population at increased risk for accelerated functional decline. This protocol is designed to learn more about the effects of functional status (also known as "frailty") in liver transplant patients and patient outcomes both before and after liver transplant.

Detailed Description

Subjects in this study will be asked questions regarding functional status and ability to do activities at home. Subjects will also be asked to complete several physical tests to assess functional status. For example, subjects will be asked to stand up from a chair several times, balance with their feet together, and walk down a hall as quickly as possible. Subjects will also be asked to perform a hand grip strength test.

Subjects will be assessed at baseline and at every clinic visit in the pre-transplant setting. Subjects will again be assessed at 3, 6, and 12 months post-transplant.

Study Timeline

• Study Start: 2015-10-06
• Study First Submitted: 2017-03-10
• Study First Submitted QC: 2019-03-07
• Study First Posted: 2019-03-12
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-28
• Last Update Posted: 2024-01-30
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Adults (≥18 years old)
• Listed for liver transplantation, or are "listable" - i.e, have undergone formal evaluation and been approved for listing if/when patients achieve high enough priority
• Are seen in the outpatient clinic setting

Exclusion Criteria

• Have severe hepatic encephalopathy at enrollment (defined by the time to complete the Numbers Connection Test (NCT) > 120 seconds, which is the first test that the participants complete upon enrollment).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
36 Item Short Form Survey Instrument (SF-36)	At 1 year post transplantation	Patient will complete a 36 question questionnaire about quality of life at 1 year post transplantation.
Fried Frailty Index measurements in 300 patients with end-stage liver disease awaiting liver transplantation	5 years	Fried Frailty is calculated by combining into one score measurements of: * Exhaustion: number of days patient felt exhaustion in the past 7 days; * Physical activity: has the subject performed any weight bearing activity in the past month? (Possible answers: yes or no).; * Grip strength test using dynamometer: Three measurements reported in kg.; * Walking speed in a 13-foot (4 meters) walk: Three measurements reported in seconds; * Unintentional Weight Loss: report if patient has lost 10 lbs or more in the last year.; * Minnesota Leisure Time Physical Activity Questionnaire (MNLTPA) calculated as a value of 1 for males with MNLTPA score less than 383 kcal/week and for females with a score less than 270 kcal/week.; Range of score is 0 to 5 with 0 being not frail and 5 being most frail
Numbers Connection test measurements in 300 patients with end-stage liver disease	5 years	Patient connects numbers that are scattered at random on a piece of paper. Reported as time (in seconds) taken to connect the numbers.
Hospitalizations	5 years	Possible answers: yes or no. If yes, report #of nights and reason.
Work status	5 years	Possible answers: working, retired, on disability, other.
Activities of daily living (ADLs)	At 1 year post transplantation	Six questions about daily activities Scoring: A response of yes to any of the questions receives a value of 1. the ADL score is measured as the sum of the values of the 6 questions. A score of 0 correlates with "most dependent" and a score of 6 is "most independent."
Instrumental Activities of Daily Living (IADLs)	At 1 year post transplantation	Eight questions about daily activities: Scoring: each question can be answered with a score of 0 or 1. The final iADL score is the sum of all values. The range of the score is 0 to 8 with 0 being most dependent and 8 being "most independent.'
Liver Frailty Index measurements in 300 patients with end-stage liver disease awaiting liver transplantation	5 years	The following measurements are used individually to assess liver frailty index: Chair stands: The patient stands up from a sitting position without using his/her arms. The time (in seconds) the patient requires to complete the task is reported.; Balance testing: patients must stand up in side by side, semi tandem and tandem positions for 10 seconds each. If the subject can't hold position for 10 seconds, the number of seconds that the subject kept in position is reported. Scoring range is 1.0 to 7.0 with 1.0 to 3.0 being "robust" and 4.5 to 7.0 being "frail"

Secondary Outcome Measures

Name	Time	Method
Correlation between frailty and outcomes both before and after liver transplantation.	5 years	The association between the subject's frailty score and their pre and post transplant outcomes will be assessed.

Trial Locations

Locations (1)

Baylor University Medical Center; 🇺🇸 Dallas, Texas, United States