Psychoeducational Intervention for ICD Patients (PEACE)

Heart Failure Clinical Trial

Official title:

Psychoeducational Intervention for ICD Patients (PEACE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00146679
• Other study ID #: 0430-1999
• Secondary ID: SR01 NR 5187-03
• Status: Completed
• Phase: N/A
• First received: September 2, 2005
• Last updated: September 6, 2013
• Start date: March 2001
• Est. completion date: February 2006

Study information

• Verified date: September 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: February 2006
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Heart Failure
• Ventricular Arrhythmias

Intervention

Behavioral:
• Psychoeducational Telephone counseling (TC)
Educational and Counseling, symptom management training and cognitive behavioral intervention to teach coping skills provided through telephone sessions
• Psychoeducational Intervention by Group (SG)
Educational and Counseling, symptom management training and cognitive behavioral intervention to teach coping skills provided in 4 group sessions
• Usual Care
Usual Care provided by providers

Locations

Country	Name	City	State
United States	Crawford Long Hospital	Atlanta	Georgia
United States	Emory University Hospital	Atlanta	Georgia
United States	Piedmont Hospital	Atlanta	Georgia
United States	St. Joseph's Hospital	Atlanta	Georgia
United States	Atlanta VA Medical Center	Decatur	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. Review. — View 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 El — View Citation

Dunbar SB. Psychosocial issues of patients with implantable cardioverter defibrillators. Am J Crit Care. 2005 Jul;14(4):294-303. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety	State-Trait Anxiety Inventory (STAI)	3, 6, 12 months	No
Primary	Depression	Beck Depression Inventory II	3, 6, 12 months	No
Primary	Functional status	Duke Activity Status Index	3, 6, 12 months	No
Secondary	Subsequent arrhythmia events documented by ICD therapy	Arrhythmia events log	3, 6, 12 months	No
Secondary	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	No
Secondary	Coping	Jalowiec Coping Scale	3, 6 12 months	No
Secondary	Symptoms	Brief Pain Inventory and Pittsburgh Sleep Quality Inventory	3,6, 12 months	No

External Links

•   link to PubMed reference for study results by Dunbar, SB et al 2009
•   LInk to PubMed reference site for Berg, SK et al 2012