HRQoL in the Low MELD Pre-tx Population

NCT01573325 | Completed Results

• 1 other identifier: STU00060397
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Percentage of Subjects With Depressive Scores Who Had a Poor HRQoL

  2-3 months

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults who are a candidate for a liver transplant at Northwester Memorial Hospital with MELD score \</=15

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• Loyola University: collaborator

MeSH Terms

Conditions

Fibrosis; Depression

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Limitations and Caveats

The small sample size and convenience sampling were limitations of this study. Additionally, since subjects were recruited from only one site, generalizability of findings is limited.

Results Point of Contact

• Title: Rebecca Duke DNP, MSN, NP-BC Transplant Surgery Nurse Practitioner
• Organization: Northwestern Memorial Hospital

rduke@nmh.org

3126951686

Study Officials

• Rebecca Duke, MSN

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Transplant Surgery Nurse Practitioner

Study Record Dates

• First Submitted: April 5, 2012
• First Posted: April 9, 2012
• Study Start: March 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: February 28, 2014
• Results First Posted: February 28, 2014

Record last verified: 2014-02