Uncertainty Management Intervention

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00938795
First received: July 10, 2009
Last updated: February 6, 2014
Last verified: February 2014
  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
Liver Diseases
Other: Uncertainty Management Intervention
Other: Comparison Conditions for Liver Transplant

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:


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 ]

Enrollment: 288
Study Start Date: February 2010
Study Completion Date: September 2013
Primary Completion Date: September 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Nebraska
The University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
United States, North Carolina
University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Duke University
Durham, North Carolina, United States, 27705
United States, Pennsylvania
The University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
Duke University
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
Principal Investigator: Laurel Williams-Salonen, RN,MSN,CCTC The University of Nebraska Medical Center
  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: February 6, 2014
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
Liver Extracts
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014