Functional Assessment in Liver Transplantation (FrAILT)

June 5, 2023 updated by: University of California, San Francisco

Functional Assessment in Liver Transplant Candidates (FrAILT) Study

This will be a prospective cohort study of patients with liver disease. Subjects will undergo geriatric assessments of frailty, functional status, and disability using functional status measures at baseline and at every clinic visit in the pre-transplant setting. Subjects will also answer questions regarding quality of life, personality, and/or cognitive function. Subjects will again undergo assessments at every clinic visit through 12 months after transplant. Then, they will be followed annually.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Patients will be asked to perform the following study procedures:

  1. Assessment of cognitive function, quality of life, and/or personality using cognitive tests and questionnaires.

  2. Measures of frailty and disability selected to capture the multi-dimensional aspects of frailty including functional status and physiologic reserve:

    Fried Frailty Score: weakness (test of grip strength), exhaustion (patient interview), slowness (gait speed), low activity (patient interview) Short Physical Performance Battery: repeated chair stands, balance testing with feet together, 13-foot walk

  3. Laboratory tests will all be obtained from the medical record: creatinine, total bilirubin, INR, sodium, albumin. All of these tests are necessary for listing for liver transplantation.
  4. Blood draw, urine and stool samples will be collected for a sub-group of 1000 patients.
  5. Adipose, muscle, liver tissue, and blood will be collected during the liver transplant surgery for a sub-group of 1000 patients.

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Completed
        • University of Arkansas for Medical Sciences
    • California
      • Loma Linda, California, United States, 92354
        • Completed
        • Loma Linda University
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California, San Francisco
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jennifer C Lai, MD, MBA
    • Illinois
      • Chicago, Illinois, United States, 60611
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins
        • Contact:
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Active, not recruiting
        • University of Michigan
    • New York
      • New York, New York, United States, 10032
    • North Carolina
      • Durham, North Carolina, United States, 27710
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15237
    • Texas
    • Washington
      • Seattle, Washington, United States, 98195
        • Active, not recruiting
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients who are being seen for the treatment of their liver disease.

Description

Inclusion Criteria:

  • Adult (≥18 years old)
  • Are seen for the treatment of liver disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frailty and functional status as assessed by grip strength, chair stands, and balance which comprise the Liver Frailty Index (LFI).
Time Frame: December 31, 2023

Grip strength: Performance-based. Measured in kilograms. This was measured in each subject's dominant hand using a hand dynamometer (Jamar Hydraulic hand dynamometer). We averaged three trials.

Chair stands: Performance-based. Measured in number of chair stands per second. Number of chair stands completed in 30 seconds.

Balance: Performance-based. Measured in seconds. Ability to balance in three positions (feet placed side to side, semitandem, and tandem) for 10 seconds each.

Liver Frailty Index (LFI): (coefficient x grip) + (coefficient x chair stands) + (coefficient x balance) +6
December 31, 2023
Examine the association between frailty and outcomes both before and after liver transplantation.
Time Frame: December 31, 2023
Outcomes measured prior to transplant will include: waiting for transplant, died pre-transplant, deactivated too sick, deactivated for social reasons/inactive, deferred not a candidate, and transplanted. Outcomes that will be measured post transplant include: still alive, died post transplant, and re-transplanted. All measures will be acquired via patient interview or review of medical records.
December 31, 2023
Evaluate the change in frailty and physical function both before and after liver transplant or treatment utilizing the LFI.
Time Frame: December 31, 2023
See outcome 1 for how LFI is measured.
December 31, 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Jennifer C Lai, MD, MBA, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2011

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

May 4, 2017

First Submitted That Met QC Criteria

July 19, 2017

First Posted (Actual)

July 24, 2017

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

June 5, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-07513
  • 1R21AG067554 (U.S. NIH Grant/Contract)
  • R21DK127275 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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