Status:
COMPLETED
Psychoeducational Intervention for ICD Patients (PEACE)
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Heart Failure
Ventricular Arrhythmias
Eligibility:
All Genders
21-75 years
Phase:
NA
Brief Summary
The overall purpose of this study is to test the effects of a nurse managed psychoeducational intervention, consisting of symptom management training (SMT) and cognitive-behavioral intervention (CBI),...
Detailed Description
Symptom distress and persistent physical and psychological changes characterize early and ongoing recovery from ventricular dysrhythmia and treatment with an implantable cardiac defibrillator (ICD). T...
Eligibility Criteria
Inclusion
- All subjects must have a nonthoracotomy insertion
- Have a primary cardiac etiology of their ventricular arrhythmia (coronary artery disease, cardiomyopathy, valve dysfunction, or combination)
- Be fluent in English
- Live within a 75 mile radius of the coordinating center
- Be accessible by telephone
- Only those receiving their first ICD, not replacement generators, will be entered.
Exclusion
- Being evaluated or on a waiting list for heart transplantation
- Congenital disease or long QT syndrome
- Disorientation documented in the pre-implantation hospitalization period
- History of psychiatric disorder or progressively debilitating comorbidity that would confound outcome measures
Key Trial Info
Start Date :
March 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
246 Patients enrolled
Trial Details
Trial ID
NCT00146679
Start Date
March 1 2001
End Date
February 1 2006
Last Update
September 10 2013
Active Locations (5)
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1
Crawford Long Hospital
Atlanta, Georgia, United States, 30308
2
Piedmont Hospital
Atlanta, Georgia, United States, 30309
3
Emory University Hospital
Atlanta, Georgia, United States, 30322
4
St. Joseph's Hospital
Atlanta, Georgia, United States, 30342