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

Primary Purpose

Cirrhosis of the Liver

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
Northwestern University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cirrhosis of the Liver focused on measuring Cirrhosis of the liver, Pre-liver transplant Candidate, Depression, Poor social support, Liver disease symptoms, Health releated quality of life

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Perceived HRQoL Score. Overall Qualty of Life Index Tool Was Utilized.
    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
    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.

    Full Information

    First Posted
    April 5, 2012
    Last Updated
    February 27, 2014
    Sponsor
    Northwestern University
    Collaborators
    Loyola University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01573325
    Brief Title
    HRQoL in the Low MELD Pre-tx Population
    Acronym
    LowMELD
    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

    2. Study Status

    Record Verification Date
    February 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2012 (undefined)
    Primary Completion Date
    July 2012 (Actual)
    Study Completion Date
    July 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Northwestern University
    Collaborators
    Loyola University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    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

    7. Study Design

    Enrollment
    50 (Actual)
    Primary Outcome Measure Information:
    Title
    Perceived HRQoL Score. Overall Qualty of Life Index Tool Was Utilized.
    Description
    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.
    Time Frame
    2-3 months
    Secondary Outcome Measure Information:
    Title
    Percentage of Subjects With Depressive Scores Who Had a Poor HRQoL
    Description
    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.
    Time Frame
    2-3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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) Adult patient between the ages of 18-75 Ability to read and speak English Must be a candidate for liver transplant per Northwestern Memorial Hospital liver transplant multidisciplinary committee Model for End Stage Liver Disease (MELD) score ≤15 Cognitive ability to complete measures Exclusion Criteria: Non-English speaking Those who have already received a liver transplant Hepatic encephalopathy as evidenced by: Grade II or more West Haven Criteria or Adapted West Haven Criteria Evidence of Asterixis upon exam at time of consent (if consented in person) Acute liver failure as etiology for liver disease. MELD score > 15 Mental retardation or cognitive disabilities preventing completion of the written questionnaire
    Study Population Description
    Adults who are a candidate for a liver transplant at Northwester Memorial Hospital with MELD score </=15
    Sampling Method
    Non-Probability Sample
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rebecca Duke, MSN
    Organizational Affiliation
    Northwestern University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    HRQoL in the Low MELD Pre-tx Population

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