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

This study has been completed.
Sponsor:
Collaborator:
Loyola University
Information provided by (Responsible Party):
Rebecca Duke, Northwestern University
ClinicalTrials.gov Identifier:
NCT01573325
First received: April 5, 2012
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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
Cirrhosis of the Liver

Study Type: Observational
Official Title: Health-Related Quality of Life in the Low Model for End-Stage Liver Disease (MELD) Pre Transplant Patient Candidate: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Perceived HRQoL Score. Overall Qualty of Life Index Tool Was Utilized. [ Time Frame: 2-3 months ] [ Designated as safety issue: No ]
    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:
  • Percentage of Subjects With Depressive Scores Who Had a Poor HRQoL [ Time Frame: 2-3 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 50
Study Start Date: March 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01573325

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

No publications provided

Responsible Party: Rebecca Duke, Transplant Surgery Nurse Practitioner, Northwestern University
ClinicalTrials.gov Identifier: NCT01573325     History of Changes
Other Study ID Numbers: STU00060397
Study First Received: April 5, 2012
Results First Received: December 26, 2012
Last Updated: February 27, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 20, 2014