Clinical Trials Directory

Trials / Completed

CompletedNCT01573325

HRQoL in the Low MELD Pre-tx Population

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

Status
Completed
Phase
Study type
Observational
Enrollment
50 (actual)
Sponsor
Northwestern University · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2012-03-01
Primary completion
2012-07-01
Completion
2012-07-01
First posted
2012-04-09
Last updated
2014-02-28
Results posted
2014-02-28

Source: ClinicalTrials.gov record NCT01573325. Inclusion in this directory is not an endorsement.