Clinical trial NCT00146679: Psychoeducational Intervention for ICD Patients (PEACE)
Official title: Psychoeducational Intervention for ICD Patients (PEACE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Ventricular Arrhythmias
Keywords: Heart failure
Ventricular arrhythmias
ICD
Psychoeducational intervention
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2005-09-07
Enrollment: 246
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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). This study will test the effect of a psycho educational intervention on psychological and physical outcomes in the first 12 months after ICD implantation. Primary outcome measures are anxiety, depression, and functional status. The effect of the intervention on variables that mediate adaptation and outcomes (symptoms, illness appraisal, and coping behaviors) will also be examined. Secondary aims will examine subsequent arrhythmia events (ICD delivered therapy) and health resource utilization in relation to the main outcomes. The intervention and study variables are based on stress and coping theory and previous research with ICD patients, which documented negative outcomes of ineffective coping and compelling relationships between increased emotional distress and subsequent arrhythmia events.

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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Anxiety
timeFrame: 3, 6, 12 months
measure: Depression
timeFrame: 3, 6, 12 months
measure: Functional status
timeFrame: 3, 6, 12 months
Secondary outcomes:
measure: Subsequent arrhythmia events documented by ICD therapy
timeFrame: 3, 6, 12 months
measure: Patterns of health resource utilization (re-hospitalization, scheduled and unscheduled outpatient visits and contacts, disability days)
timeFrame: 3, 6, 12 months
measure: Coping
timeFrame: 3, 6 12 months
measure: Symptoms
timeFrame: 3,6, 12 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Crawford Long Hospital
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Atlanta
country: United States
facility: St. Joseph's Hospital
state: Georgia
city: Decatur
country: United States
facility: Atlanta VA Medical Center
state: Georgia
Study officials:
affiliation: Emory University School of Nursing
name: Sandra B. Dunbar, RN, DSN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dunbar SB. Psychosocial issues of patients with implantable cardioverter defibrillators. Am J Crit Care. 2005 Jul;14(4):294-303.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.