HRQoL in the Low MELD Pre-tx Population

Cirrhosis of the Liver Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01573325
• Other study ID #: STU00060397
• Status: Completed
• Phase: N/A
• First received: April 5, 2012
• Last updated: February 27, 2014
• Start date: March 2012
• Est. completion date: July 2012

Study information

• Verified date: February 2014
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Cirrhosis of the Liver
• Liver Cirrhosis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Loyola University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2-3 months	No
Secondary	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.	2-3 months	No