Functional Assessment in Liver Transplantation (FrAILT)

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.

Study Overview

• Status: Recruiting
• Conditions: End Stage Liver Disease; Cirrhosis

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 Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Karen D Castro; Phone Number: 6243 214-820-6243; Email: karen.castro@BSWHealth.org

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75246
      • Recruiting
      • Baylor University Medical Center
      • Contact: Karen D Castro; Phone Number: 6243 214-820-6243; Email: karen.castro@BSWHealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Enrolled from Baylor University Medical Center.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fried Frailty Index measurements in 300 patients with end-stage liver disease awaiting liver transplantation	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 secondsUnintentional 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	5 years
Liver Frailty Index measurements in 300 patients with end-stage liver disease awaiting liver transplantation	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"	5 years
Numbers Connection test measurements in 300 patients with end-stage liver disease	Patient connects numbers that are scattered at random on a piece of paper. Reported as time (in seconds) taken to connect the numbers.	5 years
Work status	Possible answers: working, retired, on disability, other.	5 years
Hospitalizations	Possible answers: yes or no. If yes, report #of nights and reason.	5 years
Activities of daily living (ADLs)	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."	At 1 year post transplantation
Instrumental Activities of Daily Living (IADLs)	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.'	At 1 year post transplantation
36 Item Short Form Survey Instrument (SF-36)	Patient will complete a 36 question questionnaire about quality of life at 1 year post transplantation.	At 1 year post transplantation

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in measurements of fried frailty before and after liver transplantation.	The changes in frailty score pre and post transplant will be evaluated.	5 years
Change in measurements of liver frailty before and after liver transplantation.	The changes in frailty score pre and post transplant will be evaluated.	5 years

Collaborators and Investigators

• Sponsor: Baylor Research Institute
• Investigators: Principal Investigator: James Trotter, MD, Baylor Health Care System

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2015
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 10, 2017
• First Submitted That Met QC Criteria: March 7, 2019
• First Posted (Actual): March 12, 2019

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 28, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: frailty; liver transplantation; functional status
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Liver Diseases; End Stage Liver Disease
• Other Study ID Numbers: 015-243

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No