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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00845234
First Posted: February 18, 2009
Last Update Posted: February 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Aurora Denver Cardiology Associates
Medtronic
Information provided by (Responsible Party):
Samuel F. Sears, East Carolina University
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Establishing a Standard for Peri-operative ICD Patient Education: A Demonstration Project

Further study details as provided by Samuel F. Sears, East Carolina University:

Primary Outcome Measures:
  • Score on measure assessing construct of quality of life [ Time Frame: Up to 8 months after enrollment ]
    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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Samuel F. Sears, Professor, East Carolina University
ClinicalTrials.gov Identifier: NCT00845234     History of Changes
Other Study ID Numbers: 00293-2008-0356-1
First Submitted: February 17, 2009
First Posted: February 18, 2009
Last Update Posted: February 26, 2013
Last Verified: February 2013

Keywords provided by Samuel F. Sears, East Carolina University:
behavioral intervention
implantable cardioverter defibrillator
psychosocial education
anxiety
depression