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
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
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
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
NCT ID
NCT01573325
First Posted
April 5, 2012
Last Updated
February 27, 2014
Sponsor
Northwestern University
Collaborators
Loyola University
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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