Uncertainty Management Intervention

Liver Diseases Clinical Trial

Official title:

Uncertainty Management Intervention for Patients Awaiting Liver Transplant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00938795
• Other study ID #: Pro00007468
• Secondary ID: 1P01NR010948-01
• Status: Completed
• Phase: N/A
• First received: July 10, 2009
• Last updated: February 6, 2014
• Start date: February 2010
• Est. completion date: September 2013

Study information

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

Clinical Trial Summary

The goal of this study is to improve symptoms and quality of life for end-stage liver disease patients awaiting a liver transplant and their caregivers by providing them with the resources and tools to self-manage their complex concerns.

Description:

Hepatitis C Virus is the most common blood-borne infection in the U.S., affecting at least 4 million individuals, with more than 19,000 new cases occurring each year. Further, the CDC has projected a fourfold increase in the number of chronic hepatitis C patients between 1990 and 2015, and these patients are at risk for developing end stage liver disease (ESLD). By 2015 an estimated 375,000 chronic hepatitis C patients will develop cirrhosis and progress to ESLD, representing the majority of individuals who need liver transplants. ESLD is a life-limiting illness, and patients are told that, without a liver transplant, they may die.

This 5 year randomized controlled trial will test the efficacy of an Uncertainty Management Intervention delivered via telephone by a nurse to the patient and caregiver. An attention control group of patients and caregivers will receive phone calls to discuss their experience of awaiting a liver transplant. Based on the problems and concerns of patients waiting for a liver transplant and the prior success of the Intervention for patients dealing with serious chronic illness, we believe the Uncertainty Management Intervention adapted specifically for ESLD patients will lead to significant improvements in patients' and caregivers' abilities to manage the symptoms and distress associated with ESLD and the process of awaiting liver transplant.

The specific aims are to: 1) examine the effects of the Uncertainty Management Intervention on patient outcomes of psychological distress, uncertainty management, symptom control, self efficacy for symptom management, and QOL compared to an attention control group receiving calls to discuss their disease experience; 2) explore the effects of the Intervention on caregiver outcomes of uncertainty management, self-efficacy for helping the patient manage symptoms, and better QOL compared to an attention control group; 3) identify characteristics of individuals for whom the intervention is particularly effective.

Waiting for a liver transplant under conditions of uncertainty is a harrowing experience for patients and caregivers, yet there have been few attempts to test nursing interventions for ESLD patients. The overall goal of this project is to provide these patients and their caregivers the tools to self-manage their complex concerns. The anticipated outcome is ESLD patients awaiting liver transplant benefit from the Uncertainty Management Intervention, thus providing new knowledge for practitioners and policy makers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 288
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria (patient):

• Diagnosis of ESLD and on the liver transplant waiting list

• Receiving care at a Liver Clinic in the United States

• 18 years of age or older

• MELD greater than or equal to 11

• Able to read and speak English

• No major cognitive impairment

• Not a recipient of a prior transplant (any organ)

• Has a caregiver willing to participate

Inclusion Criteria (caregiver):

• 18 years of age or older

• Able to read and speak English

• Provides care to a patient meeting the above criteria

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Liver Diseases

Intervention

Other:
• Uncertainty Management Intervention
Six 30-minute telephone calls with a nurse to discuss emotional and physical aspects of liver disease and awaiting liver transplant
• Comparison Conditions for Liver Transplant
Six 30-minute telephone calls that provide structured education about liver disease.

Locations

Country	Name	City	State
United States	University of North Carolina-Chapel Hill	Chapel Hill	North Carolina
United States	Duke University	Durham	North Carolina
United States	The University of Nebraska Medical Center	Omaha	Nebraska
United States	The University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uncertainty Management		Five months	No
Secondary	Symptom control		Five months	No
Secondary	Quality of life		Five months	No
Secondary	Psychological distress		Five months	No