Clinical trial NCT03870568: Functional Assessment in Liver Transplantation
Official title: Functional Assessment in Liver Transplantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cirrhosis
End Stage Liver Disease
Keywords: frailty
liver transplantation
functional status
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2019-03-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Enrolled from Baylor University Medical Center.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Fried Frailty Index measurements in 300 patients with end-stage liver disease awaiting liver transplantation
timeFrame: 5 years
measure: Liver Frailty Index measurements in 300 patients with end-stage liver disease awaiting liver transplantation
timeFrame: 5 years
measure: Numbers Connection test measurements in 300 patients with end-stage liver disease
timeFrame: 5 years
measure: Work status
timeFrame: 5 years
measure: Hospitalizations
timeFrame: 5 years
measure: Activities of daily living (ADLs)
timeFrame: At 1 year post transplantation
measure: Instrumental Activities of Daily Living (IADLs)
timeFrame: At 1 year post transplantation
measure: 36 Item Short Form Survey Instrument (SF-36)
timeFrame: At 1 year post transplantation
Secondary outcomes:
measure: Correlation between frailty and outcomes both before and after liver transplantation.
timeFrame: 5 years
Other outcomes:
measure: Change in measurements of fried frailty before and after liver transplantation.
timeFrame: 5 years
measure: Change in measurements of liver frailty before and after liver transplantation.
timeFrame: 5 years
Locations:
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
Study officials:
affiliation: Baylor Health Care System
name: James Trotter, MD
role: PRINCIPAL_INVESTIGATOR
References: