HRQoL in the Low MELD Pre-tx Population

NCT ID: NCT01573325

Last Updated: 2014-02-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2012-07-31

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.

Conditions

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

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Loyola University

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Rebecca Duke

Transplant Surgery Nurse Practitioner

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rebecca Duke, MSN

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Countries

United States

Other Identifiers

STU00060397

Identifier Type: -

Identifier Source: org_study_id