Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
Jennifer C Lai, MD, MBA
Photo of Jennifer C Lai
Jennifer C Lai

Description

Summary

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.

Official Title

Functional Assessment in Liver Transplant Candidates (FrAILT) Study

Details

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

  1. 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.
  2. Blood draw, urine and stool samples will be collected for a sub-group of 1000 patients.
  3. Adipose, muscle, liver tissue, and blood will be collected during the liver transplant surgery for a sub-group of 1000 patients.

Keywords

End Stage Liver Disease Cirrhosis Liver Liver Transplant Frailty end stage Liver Diseases

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

  • Have severe hepatic encephalopathy at enrollment (defined by the time to complete the Numbers Connection Test (NCT) > 120 seconds).

Locations

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States
  • Loma Linda University in progress, not accepting new patients
    Loma Linda California 92354 United States

Lead Scientist at UCSF

  • Jennifer C Lai, MD, MBA
    Dr. Lai is a general and transplant hepatologist who specializes in caring for patients with chronic viral hepatitis, autoimmune disorders, and cirrhosis, particularly those awaiting liver transplantation. Her academic mission is to improve the lives of patients with end-stage liver disease through the application of core principles of geriatrics into the care of patients with cirrhosis.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
Links
We developed a novel clinical liver frailty index, consisting of hand grip strength, timed chair stands, and balance testing, that correctly reclassifies 1 in 5 patients to their accurate survival status, compared to MELDNa alone.
ID
NCT03228290
Study Type
Observational
Last Updated