Functional Assessment in Liver Transplantation

Cirrhosis Clinical Trial

— FrAILT  

Official title:

Functional Assessment in Liver Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03870568
• Other study ID #: 015-243
• Status: Recruiting
• Start date: October 6, 2015
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Baylor Research Institute
• Contact: Karen D Castro
• Phone: 214-820-6243
• Email: karen.castro[@]BSWHealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cirrhosis
• End Stage Liver Disease
• Liver Diseases

Locations

Country	Name	City	State
United States	Baylor University Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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 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	5 years
Primary	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
Primary	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
Primary	Work status	Possible answers: working, retired, on disability, other.	5 years
Primary	Hospitalizations	Possible answers: yes or no. If yes, report #of nights and reason.	5 years
Primary	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
Primary	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
Primary	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	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