HRQoL in the Low MELD Pre-tx Population (LowMELD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01573325
Recruitment Status : Completed
First Posted : April 9, 2012
Results First Posted : February 28, 2014
Last Update Posted : February 28, 2014
Loyola University
Information provided by (Responsible Party):
Rebecca Duke, Northwestern University

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

Condition or disease
Cirrhosis of the Liver

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.

Study Type : Observational
Actual Enrollment : 50 participants
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 Start Date : March 2012
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases
U.S. FDA Resources

Primary Outcome Measures :
  1. Perceived HRQoL Score. Overall Qualty of Life Index Tool Was Utilized. [ Time Frame: 2-3 months ]
    Describe perceived HRQoL in patients with low MELD scores (≤15) pre-liver transplant patient population. Overall Qualty of Life Index tool was utilized. The subscales were not utilized. The unit of measurement was scores on a scale. QLI tool has a range of 0-30 for total possible score. With the higher the score the higher the HRQoL.

Secondary Outcome Measures :
  1. Percentage of Subjects With Depressive Scores Who Had a Poor HRQoL [ Time Frame: 2-3 months ]
    Identify clinical characteristics such as environmental factors, patient biology, liver-disease related symptoms, functional status, general health perception, characteristics of the individual associated with perceived HRQoL in patients with low MELD scores (≤15) pre-transplant. What characteristics were found to be predictive of poor HRQoL. Tools utilized each assessed the specific variables including patient biology, liver disease symptoms, functional status, general health perception, and characteristics of the individual.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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

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 identifier (NCT number): NCT01573325

Sponsors and Collaborators
Northwestern University
Loyola University
Principal Investigator: Rebecca Duke, MSN Northwestern University

Responsible Party: Rebecca Duke, Transplant Surgery Nurse Practitioner, Northwestern University Identifier: NCT01573325     History of Changes
Other Study ID Numbers: STU00060397
First Posted: April 9, 2012    Key Record Dates
Results First Posted: February 28, 2014
Last Update Posted: February 28, 2014
Last Verified: February 2014

Keywords provided by Rebecca Duke, Northwestern University:
Cirrhosis of the liver
Pre-liver transplant Candidate
Poor social support
Liver disease symptoms
Health releated quality of life

Additional relevant MeSH terms:
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases