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Establishing a Standard for Peri-operative Implantable Cardioverter Defibrillator (ICD) Patient Education

This study has been completed.
Sponsor:
Collaborators:
Aurora Denver Cardiology Associates
Medtronic
Information provided by (Responsible Party):
Samuel F. Sears, East Carolina University
ClinicalTrials.gov Identifier:
NCT00845234
First received: February 17, 2009
Last updated: February 25, 2013
Last verified: February 2013
History of Changes
  Purpose

An implantable cardioverter defibrillator (ICD) administers a shock to terminate potentially life-threatening cardiac arrhythmias. The device saves lives, but presents psychological challenges for patients. At present, there is a paucity of brief interventions for ICD patients designed for administration in a clinic setting that considers issues of cost, time, and available resources. The present study examined the impact of a brief cognitive behavioral (CBT) educational intervention on primary endpoints of patient acceptance and quality of life and secondary endpoints of depression and anxiety. It was hypothesized that the intervention would result in significant improvements primary and secondary endpoints for participants in the intervention group.


Condition Intervention
Arrhythmia
 Behavioral: Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Establishing a Standard for Peri-operative ICD Patient Education: A Demonstration Project

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by East Carolina University:

Primary Outcome Measures:
  • Score on measure assessing construct of quality of life [ Time Frame: Up to 8 months after enrollment ] [ Designated as safety issue: No ]
    Quality of life will be obtained via participants scores from the Medical Outcomes Survey Short Form-12 (SF-12) measure of quality of life.


Secondary Outcome Measures:
  • Score on measure assessing depression [ Time Frame: Up to 8 months after enrollment ] [ Designated as safety issue: No ]
    Depression will be assessed via participant's self-reported scores on the depression subscale of the Hospital Anxiety and Depression Scale (HADS).

  • score on measure assessing construct of patient acceptance of device [ Time Frame: up to 8 months after enrollment ] [ Designated as safety issue: No ]
    The Florida Patient Acceptance Scale measures patient's self-reported acceptance of the implantable cardioverter defibrillator.

  • score on measure assessing anxiety [ Time Frame: Up to 8 months after enrollment ] [ Designated as safety issue: No ]
    The Hospital Anxiety and Depression Scale is comprised of two subscales- anxiety and depression. It is a self-report measure that generates a score on the patient's current level of anxiety.


Enrollment: 62
Study Start Date: July 2008
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard of Care Group
Received the current standard of care as operationally defined by the investigators- Q&A session + Video
Experimental: Intervention Group
Intervention group- Patients will receive the brief educational CBT intervention + video and Q&A session
 Behavioral: Intervention
Intervention consisted of a brief, educational CBT intervention and included the following domain areas: ICD knowledge and post-discharge care, understanding shock, stress management, family and relationships, device recall, and survivorship. The intervention was provided at baseline (0 weeks). Intervention was led by investigator and lasted 15 minutes in duration.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18+ years old
  • literate
  • newly implanted with an implantable cardioverter defibrillator (ICD)

Exclusion Criteria:

  • documented neurological sequelae associated with CVA or dementia
  • documented cognitive impairment
  • reported illiteracy
  • previously implanted ICD
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00845234

Locations
United States, Colorado
Aurora Denver Cardiology Associates
Aurora, Colorado, United States, 80012
Aurora Denver Cardiology Associates
Lone Tree, Colorado, United States, 80124
United States, North Carolina
East Carolina Heart Institute
Greenville, North Carolina, United States, 27834
Sponsors and Collaborators
East Carolina University
Aurora Denver Cardiology Associates
Medtronic
Investigators
Principal Investigator: Samuel F Sears, Ph.D. East Carolina University
  More Information

No publications provided

Responsible Party: Samuel F. Sears, Professor, East Carolina University
ClinicalTrials.gov Identifier: NCT00845234     History of Changes
Other Study ID Numbers: 00293-2008-0356-1
Study First Received: February 17, 2009
Last Updated: February 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by East Carolina University:
behavioral intervention
implantable cardioverter defibrillator
psychosocial education
anxiety
depression

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

ClinicalTrials.gov processed this record on May 16, 2013