Functional Assessment in Liver Transplantation (FrAILT)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    5000
  • sponsor
    University of California, San Francisco
Updated on 12 May 2022
liver disease
liver transplant
functional assessment

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. Then, they will be followed annually.

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.

Details
Condition End Stage Liver Disease
Clinical Study IdentifierNCT03228290
SponsorUniversity of California, San Francisco
Last Modified on12 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Adult (≥18 years old)
Are seen for the treatment of liver disease
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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