Psychoeducational Intervention for ICD Patients (PEACE)

Study Overview
=================
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.

Official Title
-----------------
Psychoeducational Intervention for ICD Patients (PEACE)

Conditions
-----------------
Heart Failure, Ventricular Arrhythmias

Intervention / Treatment
-----------------
* Behavioral: Psychoeducational Telephone counseling (TC)
* Behavioral: Psychoeducational Intervention by Group (SG)
* Behavioral: Usual Care


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Usual Care (UC)<br>Usual Care provided by providers | Behavioral: Usual Care<br>* Usual Care provided by providers<br>* Other names: UC;|
| Active Comparator: Psychoeducational Telephone CounselingTC<br>Education and Counseling for ICD patients provided through Telephone Contact | Behavioral: Psychoeducational Telephone counseling (TC)<br>* Educational and Counseling, symptom management training and cognitive behavioral intervention to teach coping skills provided through telephone sessions<br>* Other names: TC;|
| Active Comparator: Psychoeducation through Groups (SG)<br>Education and Counseling for ICD patients provided in a group setting with other ICD Patients | Behavioral: Psychoeducational Intervention by Group (SG)<br>* Educational and Counseling, symptom management training and cognitive behavioral intervention to teach coping skills provided in 4 group sessions<br>* Other names: SG;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart failure, Ventricular arrhythmias, ICD, Psychoeducational intervention