Establishing a Standard for Peri-operative Implantable Cardioverter Defibrillator (ICD) Patient Education
February 25, 2013 updated by: Samuel F. Sears, East Carolina University
Establishing a Standard for Peri-operative ICD Patient Education: A Demonstration Project
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
62
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Colorado
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Aurora, Colorado, United States, 80012
- Aurora Denver Cardiology Associates
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Lone Tree, Colorado, United States, 80124
- Aurora Denver Cardiology Associates
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North Carolina
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Greenville, North Carolina, United States, 27834
- East Carolina Heart Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Standard of Care Group
Received the current standard of care as operationally defined by the investigators- Q&A session + Video
|
|
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Experimental: Intervention Group
Intervention group- Patients will receive the brief educational CBT intervention + video and Q&A session
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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Up to 8 months after enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
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Up to 8 months after enrollment
|
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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.
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up to 8 months after enrollment
|
|
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.
|
Up to 8 months after enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Samuel F Sears, Ph.D., East Carolina University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2008
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
January 1, 2011
Study Registration Dates
First Submitted
February 17, 2009
First Submitted That Met QC Criteria
February 17, 2009
First Posted (Estimate)
February 18, 2009
Study Record Updates
Last Update Posted (Estimate)
February 26, 2013
Last Update Submitted That Met QC Criteria
February 25, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00293-2008-0356-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.