Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
5000 participants
OBSERVATIONAL
2011-10-12
2028-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Are seen for the treatment of liver disease
18 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Jennifer C Lai, MD, MBA
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Loma Linda University
Loma Linda, California, United States
University of California, San Francisco
San Francisco, California, United States
Northwestern University
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Johns Hopkins
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Columbia University
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Baylor Scott & White Health
Dallas, Texas, United States
University of Washington
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Lai JC, Feng S, Terrault NA, Lizaola B, Hayssen H, Covinsky K. Frailty predicts waitlist mortality in liver transplant candidates. Am J Transplant. 2014 Aug;14(8):1870-9. doi: 10.1111/ajt.12762. Epub 2014 Jun 16.
Lai JC, Covinsky KE, Hayssen H, Lizaola B, Dodge JL, Roberts JP, Terrault NA, Feng S. Clinician assessments of health status predict mortality in patients with end-stage liver disease awaiting liver transplantation. Liver Int. 2015 Sep;35(9):2167-73. doi: 10.1111/liv.12792. Epub 2015 Feb 12.
Wang CW, Covinsky KE, Feng S, Hayssen H, Segev DL, Lai JC. Functional impairment in older liver transplantation candidates: From the functional assessment in liver transplantation study. Liver Transpl. 2015 Dec;21(12):1465-70. doi: 10.1002/lt.24334. Epub 2015 Nov 6.
Lai JC, Dodge JL, Sen S, Covinsky K, Feng S. Functional decline in patients with cirrhosis awaiting liver transplantation: Results from the functional assessment in liver transplantation (FrAILT) study. Hepatology. 2016 Feb;63(2):574-80. doi: 10.1002/hep.28316. Epub 2015 Dec 16.
Wang CW, Feng S, Covinsky KE, Hayssen H, Zhou LQ, Yeh BM, Lai JC. A Comparison of Muscle Function, Mass, and Quality in Liver Transplant Candidates: Results From the Functional Assessment in Liver Transplantation Study. Transplantation. 2016 Aug;100(8):1692-8. doi: 10.1097/TP.0000000000001232.
Lai JC, Volk ML, Strasburg D, Alexander N. Performance-Based Measures Associate With Frailty in Patients With End-Stage Liver Disease. Transplantation. 2016 Dec;100(12):2656-2660. doi: 10.1097/TP.0000000000001433.
Sinclair M, Poltavskiy E, Dodge JL, Lai JC. Frailty is independently associated with increased hospitalisation days in patients on the liver transplant waitlist. World J Gastroenterol. 2017 Feb 7;23(5):899-905. doi: 10.3748/wjg.v23.i5.899.
Berry KA, Kent D, Seetharaman S, Wong R, Mohamad Y, Yao F, Nunez-Duarte M, Wadhwani SI, Boyarsky BJ, Rahimi RS, Duarte-Rojo A, Kappus MR, Volk ML, Ladner DP, Segev DL, McAdams-DeMarco M, Verna EC, Ganger DR, Lai JC. Loneliness in adults awaiting liver transplantation at 7 U.S. transplant centers. Ann Hepatol. 2022 Sep-Oct;27(5):100718. doi: 10.1016/j.aohep.2022.100718. Epub 2022 Apr 20.
Berry K, Duarte-Rojo A, Grab JD, Dunn MA, Boyarsky BJ, Verna EC, Kappus MR, Volk ML, McAdams-DeMarco M, Segev DL, Ganger DR, Ladner DP, Shui A, Tincopa MA, Rahimi RS, Lai JC; from the Multi-Center Functional Assessment in Liver Transplantation (FrAILT) Study. Cognitive Impairment and Physical Frailty in Patients With Cirrhosis. Hepatol Commun. 2022 Jan;6(1):237-246. doi: 10.1002/hep4.1796. Epub 2021 Aug 24.
Related Links
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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.
Other Identifiers
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