Psychoeducational Intervention for ICD Patients (PEACE)
2 other identifiers
interventional
246
1 country
5
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), during the first year after ICD implantation using a 3 group randomized clinical trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable heart-failure
Started Mar 2001
Longer than P75 for not_applicable heart-failure
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 2, 2005
CompletedFirst Posted
Study publicly available on registry
September 7, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedSeptember 10, 2013
September 1, 2013
4.3 years
September 2, 2005
September 6, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Anxiety
State-Trait Anxiety Inventory (STAI)
3, 6, 12 months
Depression
Beck Depression Inventory II
3, 6, 12 months
Functional status
Duke Activity Status Index
3, 6, 12 months
Secondary Outcomes (4)
Subsequent arrhythmia events documented by ICD therapy
3, 6, 12 months
Patterns of health resource utilization (re-hospitalization, scheduled and unscheduled outpatient visits and contacts, disability days)
3, 6, 12 months
Coping
3, 6 12 months
Symptoms
3,6, 12 months
Study Arms (3)
Usual Care (UC)
PLACEBO COMPARATORUsual Care provided by providers
Psychoeducational Telephone CounselingTC
ACTIVE COMPARATOREducation and Counseling for ICD patients provided through Telephone Contact
Psychoeducation through Groups (SG)
ACTIVE COMPARATOREducation and Counseling for ICD patients provided in a group setting with other ICD Patients
Interventions
Educational and Counseling, symptom management training and cognitive behavioral intervention to teach coping skills provided through telephone sessions
Educational and Counseling, symptom management training and cognitive behavioral intervention to teach coping skills provided in 4 group sessions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
- National Institutes of Health (NIH)collaborator
Study Sites (5)
Crawford Long Hospital
Atlanta, Georgia, 30308, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
St. Joseph's Hospital
Atlanta, Georgia, 30342, United States
Atlanta VA Medical Center
Decatur, Georgia, 30033, United States
Related Publications (6)
Dunbar SB. Psychosocial issues of patients with implantable cardioverter defibrillators. Am J Crit Care. 2005 Jul;14(4):294-303.
PMID: 15980420BACKGROUNDO'Brien MC, Langberg J, Valderrama AL, Kirkendoll K, Romeiko N, Dunbar SB. Implantable cardioverter defibrillator storm: nursing care issues for patients and families. Crit Care Nurs Clin North Am. 2005 Mar;17(1):9-16, ix. doi: 10.1016/j.ccell.2004.09.002.
PMID: 15749396BACKGROUNDDunbar SB, Funk M, Wood K, Valderrama AL. Ventricular dysrhythmias: nursing approaches to health outcomes. J Cardiovasc Nurs. 2004 Sep-Oct;19(5):316-28. doi: 10.1097/00005082-200409000-00007.
PMID: 15495892BACKGROUNDBerg SK, Higgins M, Reilly CM, Langberg JJ, Dunbar SB. Sleep quality and sleepiness in persons with implantable cardioverter defibrillators: outcome from a clinical randomized longitudinal trial. Pacing Clin Electrophysiol. 2012 Apr;35(4):431-43. doi: 10.1111/j.1540-8159.2011.03328.x. Epub 2012 Feb 3.
PMID: 22303998RESULTDunbar SB, Langberg JJ, Reilly CM, Viswanathan B, McCarty F, Culler SD, O'Brien MC, Weintraub WS. Effect of a psychoeducational intervention on depression, anxiety, and health resource use in implantable cardioverter defibrillator patients. Pacing Clin Electrophysiol. 2009 Oct;32(10):1259-71. doi: 10.1111/j.1540-8159.2009.02495.x.
PMID: 19796343RESULTSmith G, Dunbar SB, Valderrama AL, Viswanathan B. Gender differences in implantable cardioverter-defibrillator patients at the time of insertion. Prog Cardiovasc Nurs. 2006 Spring;21(2):76-82. doi: 10.1111/j.0889-7204.2006.04843.x.
PMID: 16760689RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sandra B. Dunbar, RN, DSN
Emory University School of Nursing
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 2, 2005
First Posted
September 7, 2005
Study Start
March 1, 2001
Primary Completion
June 1, 2005
Study Completion
February 1, 2006
Last Updated
September 10, 2013
Record last verified: 2013-09