- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00938795
Uncertainty Management Intervention
Uncertainty Management Intervention for Patients Awaiting Liver Transplant
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nebraska
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Omaha, Nebraska, United States, 68198
- The University of Nebraska Medical Center
-
-
North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina-Chapel Hill
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Durham, North Carolina, United States, 27705
- Duke University
-
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15261
- The University of Pittsburgh
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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.
|
Six 30-minute telephone calls with a nurse to discuss emotional and physical aspects of liver disease and awaiting liver transplant
|
Other: Comparison Conditions for Liver Disease
Six 30-minute telephone calls that provide structured education about liver disease.
|
Six 30-minute telephone calls that provide structured education about liver disease.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Uncertainty Management
Time Frame: Five months
|
Five months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Symptom control
Time Frame: Five months
|
Five months
|
Quality of life
Time Frame: Five months
|
Five months
|
Psychological distress
Time Frame: Five months
|
Five months
|
Collaborators and Investigators
Sponsor
Collaborators
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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00007468
- 1P01NR010948-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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