Assessing functional health in patients awaiting liver transplants
Functional Assessment in Liver Transplant Candidates (FrAILT) Study
This study is trying to see how frailty and overall health affect people waiting for liver transplants by tracking their physical and mental abilities over a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 5000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 12 sites (Little Rock, Arkansas and 11 other locations) |
| Trial ID | NCT03228290 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with end-stage liver disease, evaluating their frailty, functional status, and disability through comprehensive geriatric assessments. Participants will undergo cognitive function tests, quality of life questionnaires, and various physical performance measures at baseline and during regular clinic visits leading up to and following their liver transplant. The study aims to gather extensive data on the multi-dimensional aspects of frailty and its impact on transplant outcomes over a 12-month period post-surgery. Additionally, biological samples will be collected from a subgroup of patients to further investigate the relationship between frailty and liver health.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are being treated for liver disease.
Not a fit: Patients who are not being treated for liver disease or are under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of frailty in liver transplant candidates, potentially leading to improved patient selection and outcomes.
How similar studies have performed: Other studies have shown success in assessing frailty and functional status in transplant populations, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult (≥18 years old) * Are seen for the treatment of liver disease
Where this trial is running
Little Rock, Arkansas and 11 other locations
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (Completed)
- Loma Linda University — Loma Linda, California, United States (Completed)
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
- Northwestern University — Chicago, Illinois, United States (Recruiting)
- Indiana University — Indianapolis, Indiana, United States (Active_not_recruiting)
- Johns Hopkins — Baltimore, Maryland, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Completed)
- Columbia University — New York, New York, United States (Recruiting)
- Duke University Medical Center — Durham, North Carolina, United States (Recruiting)
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
- Baylor Scott & White Health — Dallas, Texas, United States (Recruiting)
- University of Washington — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Jennifer C Lai, MD, MBA — University of California, San Francisco
- Study coordinator: Jennifer C Lai, MD, MBA
- Email: jennifer.lai@ucsf.edu
- Phone: (415) 476-6422
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.