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Psychoeducational Intervention for ICD Patients (PEACE)

Primary Purpose

Heart Failure, Ventricular Arrhythmias

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychoeducational Telephone counseling (TC)
Psychoeducational Intervention by Group (SG)
Usual Care
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure focused on measuring Heart failure, Ventricular arrhythmias, ICD, Psychoeducational intervention

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Crawford Long Hospital
  • Piedmont Hospital
  • Emory University Hospital
  • St. Joseph's Hospital
  • Atlanta VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Usual Care (UC)

Psychoeducational Telephone CounselingTC

Psychoeducation through Groups (SG)

Arm Description

Usual Care provided by providers

Education and Counseling for ICD patients provided through Telephone Contact

Education and Counseling for ICD patients provided in a group setting with other ICD Patients

Outcomes

Primary Outcome Measures

Anxiety
State-Trait Anxiety Inventory (STAI)
Depression
Beck Depression Inventory II
Functional status
Duke Activity Status Index

Secondary Outcome Measures

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

Full Information

First Posted
September 2, 2005
Last Updated
September 6, 2013
Sponsor
Emory University
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00146679
Brief Title
Psychoeducational Intervention for ICD Patients (PEACE)
Official Title
Psychoeducational Intervention for ICD Patients (PEACE)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
February 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Ventricular Arrhythmias
Keywords
Heart failure, Ventricular arrhythmias, ICD, Psychoeducational intervention

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
246 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care (UC)
Arm Type
Placebo Comparator
Arm Description
Usual Care provided by providers
Arm Title
Psychoeducational Telephone CounselingTC
Arm Type
Active Comparator
Arm Description
Education and Counseling for ICD patients provided through Telephone Contact
Arm Title
Psychoeducation through Groups (SG)
Arm Type
Active Comparator
Arm Description
Education and Counseling for ICD patients provided in a group setting with other ICD Patients
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducational Telephone counseling (TC)
Other Intervention Name(s)
TC
Intervention Description
Educational and Counseling, symptom management training and cognitive behavioral intervention to teach coping skills provided through telephone sessions
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducational Intervention by Group (SG)
Other Intervention Name(s)
SG
Intervention Description
Educational and Counseling, symptom management training and cognitive behavioral intervention to teach coping skills provided in 4 group sessions
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Other Intervention Name(s)
UC
Intervention Description
Usual Care provided by providers
Primary Outcome Measure Information:
Title
Anxiety
Description
State-Trait Anxiety Inventory (STAI)
Time Frame
3, 6, 12 months
Title
Depression
Description
Beck Depression Inventory II
Time Frame
3, 6, 12 months
Title
Functional status
Description
Duke Activity Status Index
Time Frame
3, 6, 12 months
Secondary Outcome Measure Information:
Title
Subsequent arrhythmia events documented by ICD therapy
Description
Arrhythmia events log
Time Frame
3, 6, 12 months
Title
Patterns of health resource utilization (re-hospitalization, scheduled and unscheduled outpatient visits and contacts, disability days)
Description
Health Resource Use Questionnaire (HRUQ)
Time Frame
3, 6, 12 months
Title
Coping
Description
Jalowiec Coping Scale
Time Frame
3, 6 12 months
Title
Symptoms
Description
Brief Pain Inventory and Pittsburgh Sleep Quality Inventory
Time Frame
3,6, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra B. Dunbar, RN, DSN
Organizational Affiliation
Emory University School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Crawford Long Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
St. Joseph's Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Atlanta VA Medical Center
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15980420
Citation
Dunbar SB. Psychosocial issues of patients with implantable cardioverter defibrillators. Am J Crit Care. 2005 Jul;14(4):294-303.
Results Reference
background
PubMed Identifier
15749396
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. doi: 10.1016/j.ccell.2004.09.002.
Results Reference
background
PubMed Identifier
15495892
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. doi: 10.1097/00005082-200409000-00007.
Results Reference
background
PubMed Identifier
22303998
Citation
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: 10.1111/j.1540-8159.2011.03328.x. Epub 2012 Feb 3.
Results Reference
result
PubMed Identifier
19796343
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 Electrophysiol. 2009 Oct;32(10):1259-71. doi: 10.1111/j.1540-8159.2009.02495.x.
Results Reference
result
PubMed Identifier
16760689
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. doi: 10.1111/j.0889-7204.2006.04843.x.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/22303998
Description
LInk to PubMed reference site for Berg, SK et al 2012
URL
http://www.ncbi.nlm.nih.gov/pubmed/19796343
Description
link to PubMed reference for study results by Dunbar, SB et al 2009

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Psychoeducational Intervention for ICD Patients (PEACE)

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