Uncertainty Management Intervention

Not Applicable

Completed

• Conditions: Liver Diseases
• Interventions: Other: Uncertainty Management Intervention; Other: Comparison Conditions for Liver Transplant

• Registration Number: NCT00938795
• Lead Sponsor: Duke University

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-07-10
• Study First Submitted QC: 2009-07-10
• Study First Posted: 2009-07-14
• Study Start: 2010-02
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-06
• Last Update Posted: 2014-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 288

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Uncertainty Management Intervention	Uncertainty Management Intervention	The Uncertainty Management Intervention will consist of six 30-minute phone calls with a study educator to discuss issues of psychological distress, uncertainty management, symptom control, self efficacy for symptom management, and quality of life.
Comparison Conditions for Liver Disease	Comparison Conditions for Liver Transplant	Six 30-minute telephone calls that provide structured education about liver disease.

Primary Outcome Measures

Name	Time	Method
Uncertainty Management	Five months

Secondary Outcome Measures

Name	Time	Method
Quality of life	Five months
Psychological distress	Five months
Symptom control	Five months

Trial Locations

Locations (4)

The University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

The University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

University of North Carolina-Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Duke University; 🇺🇸 Durham, North Carolina, United States