Functional Assessment in Liver Transplantation (FrAILT)

Baylor Scott and White Health (BSWH)

Status: Terminated

Conditions: Cirrhosis; End Stage Liver Disease

Study type: Observational

Funder types: Other

Identifiers

NCT03870568

015-243

Details and patient eligibility

About

In order to ensure the equity of the liver allocation process, it is important to create objective, scientifically validated markers of frailty in patients with end-stage liver disease that accurately predict patient outcomes. Many measures have been developed to assess this clinical state in elderly patients, but none have been applied to patients with cirrhosis, a population at increased risk for accelerated functional decline. This protocol is designed to learn more about the effects of functional status (also known as "frailty") in liver transplant patients and patient outcomes both before and after liver transplant.

Full description

Subjects in this study will be asked questions regarding functional status and ability to do activities at home. Subjects will also be asked to complete several physical tests to assess functional status. For example, subjects will be asked to stand up from a chair several times, balance with their feet together, and walk down a hall as quickly as possible. Subjects will also be asked to perform a hand grip strength test.

Subjects will be assessed at baseline and at every clinic visit in the pre-transplant setting. Subjects will again be assessed at 3, 6, and 12 months post-transplant.

Enrollment: 411 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults (≥18 years old)
• Listed for liver transplantation, or are "listable" - i.e, have undergone formal evaluation and been approved for listing if/when patients achieve high enough priority
• Are seen in the outpatient clinic setting

Exclusion criteria

• Have severe hepatic encephalopathy at enrollment (defined by the time to complete the Numbers Connection Test (NCT) > 120 seconds, which is the first test that the participants complete upon enrollment).