Psychoeducational Intervention for ICD Patients (PEACE)
NCT ID: NCT00146679
Last Updated: 2013-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
246 participants
INTERVENTIONAL
2001-03-31
2006-02-28
Brief Summary
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Detailed Description
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A three-group, randomized, clinical trial with a repeated-measures design will be used. ICD patients (n=240) will be randomized to receive either the usual standard of care, symptom management training plus cognitive behavioral intervention delivered in a group format, or symptom management training plus cognitive behavioral intervention delivered by nurse provided telephone counseling. The symptom management-training component will be provided in the acute care setting and will focus on symptoms of pain, sleep disturbances and ICD shocks. The four cognitive behavioral sessions by group or telephone format will begin 6-8 weeks after hospitalization and will focus on illness reappraisal and coping skill training. Thus the intervention is designed to bridge the acute and outpatient continuum of care. A booster intervention will be provided at 4 months after implantation. Timeframes for evaluations are baseline, 1, 3, 6, and 12 months after implantation. This study will test whether a cost-effective, accessible, theoretically based, nurse-managed, psycho educational intervention provides an incremental effect over usual care in improving psychological and physical outcomes in ICD patients. This study will provide data upon which future clinical practice guidelines can be based and will establish priorities for patient care according to which interventions are linked to improved adaptive processes and patient outcomes. Greater understanding of the relationships among psychological and physical outcomes, arrhythmia events, and health resource utilization are important for future studies and evaluation of clinical practice with ICD patients.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Usual Care (UC)
Usual Care provided by providers
Usual Care
Usual Care provided by providers
Psychoeducational Telephone CounselingTC
Education and Counseling for ICD patients provided through Telephone Contact
Psychoeducational Telephone counseling (TC)
Educational and Counseling, symptom management training and cognitive behavioral intervention to teach coping skills provided through telephone sessions
Psychoeducation through Groups (SG)
Education and Counseling for ICD patients provided in a group setting with other ICD Patients
Psychoeducational Intervention by Group (SG)
Educational and Counseling, symptom management training and cognitive behavioral intervention to teach coping skills provided in 4 group sessions
Interventions
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Psychoeducational Telephone counseling (TC)
Educational and Counseling, symptom management training and cognitive behavioral intervention to teach coping skills provided through telephone sessions
Psychoeducational Intervention by Group (SG)
Educational and Counseling, symptom management training and cognitive behavioral intervention to teach coping skills provided in 4 group sessions
Usual Care
Usual Care provided by providers
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
21 Years
75 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
Emory University
OTHER
Responsible Party
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Sandra B. Dunbar, RN
Professor
Principal Investigators
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Sandra B. Dunbar, RN, DSN
Role: PRINCIPAL_INVESTIGATOR
Emory University School of Nursing
Locations
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Crawford Long Hospital
Atlanta, Georgia, United States
Piedmont Hospital
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
St. Joseph's Hospital
Atlanta, Georgia, United States
Atlanta VA Medical Center
Decatur, Georgia, United States
Countries
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References
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Dunbar SB. Psychosocial issues of patients with implantable cardioverter defibrillators. Am J Crit Care. 2005 Jul;14(4):294-303.
O'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.
Dunbar 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.
Berg 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.
Dunbar 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.
Smith 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.
Related Links
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LInk to PubMed reference site for Berg, SK et al 2012
link to PubMed reference for study results by Dunbar, SB et al 2009
Other Identifiers
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SR01 NR 5187-03
Identifier Type: -
Identifier Source: secondary_id
0430-1999
Identifier Type: -
Identifier Source: org_study_id