Psychoeducational Intervention for ICD Patients (PEACE)

Not Applicable

Completed

• Conditions: Heart Failure; Ventricular Arrhythmias
• Interventions: Behavioral: Usual Care; Behavioral: Psychoeducational Telephone counseling (TC); Behavioral: Psychoeducational Intervention by Group (SG)

• Registration Number: NCT00146679
• Lead Sponsor: Emory University

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.

Study Timeline

• Study Start: 2001-03
• Primary Completion: 2005-06
• Study First Submitted: 2005-09-02
• Study First Submitted QC: 2005-09-06
• Study First Posted: 2005-09-07
• Study Completion: 2006-02
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-06
• Last Update Posted: 2013-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 246

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care (UC)	Usual Care	Usual Care provided by providers
Psychoeducational Telephone CounselingTC	Psychoeducational Telephone counseling (TC)	Education and Counseling for ICD patients provided through Telephone Contact
Psychoeducation through Groups (SG)	Psychoeducational Intervention by Group (SG)	Education and Counseling for ICD patients provided in a group setting with other ICD Patients

Primary Outcome Measures

Name	Time	Method
Anxiety	3, 6, 12 months	State-Trait Anxiety Inventory (STAI)
Depression	3, 6, 12 months	Beck Depression Inventory II
Functional status	3, 6, 12 months	Duke Activity Status Index

Secondary Outcome Measures

Name	Time	Method
Subsequent arrhythmia events documented by ICD therapy	3, 6, 12 months	Arrhythmia events log
Patterns of health resource utilization (re-hospitalization, scheduled and unscheduled outpatient visits and contacts, disability days)	3, 6, 12 months	Health Resource Use Questionnaire (HRUQ)
Coping	3, 6 12 months	Jalowiec Coping Scale
Symptoms	3,6, 12 months	Brief Pain Inventory and Pittsburgh Sleep Quality Inventory

Trial Locations

Locations (5)

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