Psychoeducational Intervention for ICD Patients (PEACE)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sandra B. Dunbar, RN, Emory University
ClinicalTrials.gov Identifier:
NCT00146679
First received: September 2, 2005
Last updated: September 6, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Heart Failure
Ventricular Arrhythmias
Behavioral: Psychoeducational Telephone counseling (TC)
Behavioral: Psychoeducational Intervention by Group (SG)
Behavioral: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Psychoeducational Intervention for ICD Patients (PEACE)

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Anxiety [ Time Frame: 3, 6, 12 months ] [ Designated as safety issue: No ]
    State-Trait Anxiety Inventory (STAI)

  • Depression [ Time Frame: 3, 6, 12 months ] [ Designated as safety issue: No ]
    Beck Depression Inventory II

  • Functional status [ Time Frame: 3, 6, 12 months ] [ Designated as safety issue: No ]
    Duke Activity Status Index


Secondary Outcome Measures:
  • Subsequent arrhythmia events documented by ICD therapy [ Time Frame: 3, 6, 12 months ] [ Designated as safety issue: No ]
    Arrhythmia events log

  • Patterns of health resource utilization (re-hospitalization, scheduled and unscheduled outpatient visits and contacts, disability days) [ Time Frame: 3, 6, 12 months ] [ Designated as safety issue: No ]
    Health Resource Use Questionnaire (HRUQ)

  • Coping [ Time Frame: 3, 6 12 months ] [ Designated as safety issue: No ]
    Jalowiec Coping Scale

  • Symptoms [ Time Frame: 3,6, 12 months ] [ Designated as safety issue: No ]
    Brief Pain Inventory and Pittsburgh Sleep Quality Inventory


Enrollment: 246
Study Start Date: March 2001
Study Completion Date: February 2006
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Usual Care (UC)
Usual Care provided by providers
Behavioral: Usual Care
Usual Care provided by providers
Other Name: 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 Name: 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 Name: SG

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

Ages Eligible for Study:   21 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146679

Locations
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Crawford Long Hospital
Atlanta, Georgia, United States, 30308
St. Joseph's Hospital
Atlanta, Georgia, United States, 30342
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Atlanta VA Medical Center
Decatur, Georgia, United States, 30033
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Sandra B. Dunbar, RN, DSN Emory University School of Nursing
  More Information

Additional Information:
Publications:
Responsible Party: Sandra B. Dunbar, RN, Professor, Emory University
ClinicalTrials.gov Identifier: NCT00146679     History of Changes
Other Study ID Numbers: 0430-1999, SR01 NR 5187-03
Study First Received: September 2, 2005
Last Updated: September 6, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
Heart failure
Ventricular arrhythmias
ICD
Psychoeducational intervention

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Failure
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014