NCT03228290 · University of California, San Francisco
Functional Assessment in Liver Transplantation
(FrAILT)
What this study is about
This will be a forward-looking group of participants 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.
View original scientific description
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.
Primary outcome measures
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
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Adult (≥18 years old)
- Are seen for the treatment of liver disease
Where
- Little Rock, Arkansas
- Loma Linda, California
- San Francisco, California
- Chicago, Illinois
- Indianapolis, Indiana
- Baltimore, Maryland
- Ann Arbor, Michigan
- New York, New York
- Durham, North Carolina
- Pittsburgh, Pennsylvania
- Dallas, Texas
- Seattle, Washington
Collaborators
National Institute on Aging (NIA), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 14, 2026 · Source of record for eligibility and locations