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Uncertainty Management Intervention

This study is currently recruiting participants.
Verified December 2012 by Duke University
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00938795
First received: July 10, 2009
Last updated: December 20, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Liver Diseases
 Other: Uncertainty Management Intervention
Other: Comparison Conditions for Liver Transplant
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Uncertainty Management Intervention for Patients Awaiting Liver Transplant

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Uncertainty Management [ Time Frame: Five months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptom control [ Time Frame: Five months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Five months ] [ Designated as safety issue: No ]
  • Psychological distress [ Time Frame: Five months ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: February 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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 Disease
Six 30-minute telephone calls that provide structured education about liver disease.
 Other: Comparison Conditions for Liver Transplant
Six 30-minute telephone calls that provide structured education about liver disease.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00938795

Contacts
Contact: Donald Bailey, PhD 919-681-3003 Chip.Bailey@duke.edu

Locations
United States, North Carolina
University of North Carolina-Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Paul H Hayashi, MD, MPH     919-966-2516     paul_hayashi@med.unc.edu    
Duke University Recruiting
Durham, North Carolina, United States, 27705
Contact: Donald Bailey, PhD     919-681-3003     Chip.Bailey@duke.edu    
United States, Pennsylvania
The University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Annette Devito Dabbs, PhD, RN     412-624-5314     ajdst42@pitt.edu    
Sponsors and Collaborators
Duke University
National Institute of Nursing Research (NINR)
Investigators
Principal Investigator: James Tulsky, MD Duke University School of Nursing
Principal Investigator: Donald Bailey, PhD Duke University School of Nursing
Principal Investigator: Annette Devito Dabbs, PhD, RN The University of Pittsburgh
Principal Investigator: Paul H. Hayashi, MD, MPH University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00938795     History of Changes
Other Study ID Numbers: Pro00007468, 1P01NR010948-01
Study First Received: July 10, 2009
Last Updated: December 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
liver disease
uncertainty
self management

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on June 17, 2013