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Functional Assessment in Liver Transplantation (FrAILT)

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ClinicalTrials.gov Identifier: NCT03870568
Recruitment Status : Recruiting
First Posted : March 12, 2019
Last Update Posted : August 28, 2020
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute

Study Description
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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.

Condition or disease
Cirrhosis End Stage Liver Disease

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Functional Assessment in Liver Transplantation
Actual Study Start Date : October 6, 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Fried Frailty Index measurements in 300 patients with end-stage liver disease awaiting liver transplantation [ Time Frame: 5 years ]

    Fried Frailty is calculated by combining into one score measurements of:

    • Exhaustion: number of days patient felt exhaustion in the past 7 days
    • Physical activity: has the subject performed any weight bearing activity in the past month? (Possible answers: yes or no).
    • Grip strength test using dynamometer: Three measurements reported in kg.

    • Walking speed in a 13-foot (4 meters) walk: Three measurements reported in seconds

      • Unintentional Weight Loss: report if patient has lost 10 lbs or more in the last year.
      • Minnesota Leisure Time Physical Activity Questionnaire (MNLTPA) calculated as a value of 1 for males with MNLTPA score less than 383 kcal/week and for females with a score less than 270 kcal/week.

    Range of score is 0 to 5 with 0 being not frail and 5 being most frail


  2. Liver Frailty Index measurements in 300 patients with end-stage liver disease awaiting liver transplantation [ Time Frame: 5 years ]

    The following measurements are used individually to assess liver frailty index:

    Chair stands: The patient stands up from a sitting position without using his/her arms. The time (in seconds) the patient requires to complete the task is reported.

    Balance testing: patients must stand up in side by side, semi tandem and tandem positions for 10 seconds each. If the subject can't hold position for 10 seconds, the number of seconds that the subject kept in position is reported. Scoring range is 1.0 to 7.0 with 1.0 to 3.0 being "robust" and 4.5 to 7.0 being "frail"


  3. Numbers Connection test measurements in 300 patients with end-stage liver disease [ Time Frame: 5 years ]
    Patient connects numbers that are scattered at random on a piece of paper. Reported as time (in seconds) taken to connect the numbers.

  4. Work status [ Time Frame: 5 years ]
    Possible answers: working, retired, on disability, other.

  5. Hospitalizations [ Time Frame: 5 years ]
    Possible answers: yes or no. If yes, report #of nights and reason.

  6. Activities of daily living (ADLs) [ Time Frame: At 1 year post transplantation ]
    Six questions about daily activities Scoring: A response of yes to any of the questions receives a value of 1. the ADL score is measured as the sum of the values of the 6 questions. A score of 0 correlates with "most dependent" and a score of 6 is "most independent."

  7. Instrumental Activities of Daily Living (IADLs) [ Time Frame: At 1 year post transplantation ]

    Eight questions about daily activities:

    Scoring: each question can be answered with a score of 0 or 1. The final iADL score is the sum of all values. The range of the score is 0 to 8 with 0 being most dependent and 8 being "most independent.'


  8. 36 Item Short Form Survey Instrument (SF-36) [ Time Frame: At 1 year post transplantation ]
    Patient will complete a 36 question questionnaire about quality of life at 1 year post transplantation.


Secondary Outcome Measures :
  1. Correlation between frailty and outcomes both before and after liver transplantation. [ Time Frame: 5 years ]
    The association between the subject's frailty score and their pre and post transplant outcomes will be assessed.


Other Outcome Measures:
  1. Change in measurements of fried frailty before and after liver transplantation. [ Time Frame: 5 years ]
    The changes in frailty score pre and post transplant will be evaluated.

  2. Change in measurements of liver frailty before and after liver transplantation. [ Time Frame: 5 years ]
    The changes in frailty score pre and post transplant will be evaluated.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Enrolled from Baylor University Medical Center.
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03870568


Contacts
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Contact: Karen D Castro 214-820-6243 ext 6243 karen.castro@BSWHealth.org

Locations
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United States, Texas
Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75246
Contact: Karen D Castro    214-820-6243 ext 6243    karen.castro@BSWHealth.org   
Sponsors and Collaborators
Baylor Research Institute
Investigators
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Principal Investigator: James Trotter, MD Baylor Health Care System
More Information
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Responsible Party: Baylor Research Institute
ClinicalTrials.gov Identifier: NCT03870568    
Other Study ID Numbers: 015-243
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Baylor Research Institute:
frailty
liver transplantation
functional status
Additional relevant MeSH terms:
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Liver Diseases
End Stage Liver Disease
Digestive System Diseases
Liver Failure
Hepatic Insufficiency