Clinical trial NCT01573325: HRQoL in the Low MELD Pre-tx Population
Official title: Health-Related Quality of Life in the Low Model for End-Stage Liver Disease (MELD) Pre Transplant Patient Candidate: A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cirrhosis of the Liver
Keywords: Cirrhosis of the liver
Pre-liver transplant Candidate
Depression
Poor social support
Liver disease symptoms
Health releated quality of life
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Loyola University
First posted: 2012-04-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults who are a candidate for a liver transplant at Northwester Memorial Hospital with MELD score \</=15

Brief summary: The purpose of this study is to describe the HRQoL in those with MELD scores \</= 15 in a single center for those who are pre-liver transplant candidates

Detailed description: The liver organ allocation system was significantly revised in 2002, allowing a more objective prioritization of liver transplant candidates. The revised Model for End Stage Liver Disease (MELD) system is based primarily on laboratory test results. Candidates with MELD scores of less than 15 are considered to be low priority for cadaveric liver transplant and have limited treatment options. Yet patients with low MELD scores may suffer from an array of symptoms associated with liver disease such as fatigue, sleep disturbances, and depression - all of which erode health-related quality of life (HRQoL). No previous studies were found that examined HRQoL in low MELD transplant patients. A better understanding of the HRQoL of these patients will allow clinicians to better meet their needs. Therefore, the aims of the proposed pilot capstone project are to examine HRQoL and to identify demographic and clinical characteristics including liver-disease related symptoms, functional status, perceived social support, biological functioning and mental health associated with HRQoL in pre-liver transplant candidates with low MELD scores. The revised Wilson and Cleary Quality of Life Model will be used to guide the project. Fifty pre-transplant liver candidates with MELD scores \< 15 will be enrolled in the descriptive, cross-sectional pilot study. Participants will complete a written questionnaire measuring perceived HRQoL and clinical characteristics. Descriptive and correlational statistics will be used to analyze the data. Findings from this project will identify trends in factors that contribute to a HRQoL of this population and provide the foundation for a larger future project.

Eligibility criteria: Inclusion Criteria:

1. Must be a patient in the liver transplant clinic at Northwestern Memorial Hospital or one of its satellite clinics (including Washington, Illinois; Portage, Indiana; Glenview, Illinois, Oakbrook, Illinois; Joliet, Illinois)
2. Adult patient between the ages of 18-75
3. Ability to read and speak English
4. Must be a candidate for liver transplant per Northwestern Memorial Hospital liver transplant multidisciplinary committee
5. Model for End Stage Liver Disease (MELD) score ≤15
6. Cognitive ability to complete measures

Exclusion Criteria:

1. Non-English speaking
2. Those who have already received a liver transplant
3. Hepatic encephalopathy as evidenced by:

   1. Grade II or more West Haven Criteria or Adapted West Haven Criteria
   2. Evidence of Asterixis upon exam at time of consent (if consented in person)
4. Acute liver failure as etiology for liver disease.
5. MELD score \> 15
6. Mental retardation or cognitive disabilities preventing completion of the written questionnaire

Primary outcomes:
measure: Perceived HRQoL Score. Overall Qualty of Life Index Tool Was Utilized.
timeFrame: 2-3 months
Secondary outcomes:
measure: Percentage of Subjects With Depressive Scores Who Had a Poor HRQoL
timeFrame: 2-3 months
Other outcomes:
Locations:
Study officials:
affiliation: Northwestern University
name: Rebecca Duke, MSN
role: PRINCIPAL_INVESTIGATOR
References: