Psychoeducational Intervention for ICD Patients (PEACE)

September 6, 2013 updated by: Sandra B. Dunbar, RN, Emory University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

246

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
      • Atlanta, Georgia, United States, 30309
        • Piedmont Hospital
      • Atlanta, Georgia, United States, 30308
        • Crawford Long Hospital
      • Atlanta, Georgia, United States, 30342
        • St. Joseph's Hospital
      • Decatur, Georgia, United States, 30033
        • Atlanta VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: 3, 6, 12 months
State-Trait Anxiety Inventory (STAI)
3, 6, 12 months
Depression
Time Frame: 3, 6, 12 months
Beck Depression Inventory II
3, 6, 12 months
Functional status
Time Frame: 3, 6, 12 months
Duke Activity Status Index
3, 6, 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Sandra B. Dunbar, RN, DSN, Emory University School of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2001

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

September 2, 2005

First Submitted That Met QC Criteria

September 6, 2005

First Posted (Estimate)

September 7, 2005

Study Record Updates

Last Update Posted (Estimate)

September 10, 2013

Last Update Submitted That Met QC Criteria

September 6, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0430-1999
  • SR01 NR 5187-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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