An interventional study of Intervention in Arrhythmia, sponsored by East Carolina University. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-26.
Sponsored by East Carolina University · Not applicable, Interventional, and Treatment
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.
885 studies on the registry are indexed under Arrhythmias, Cardiac; 235 are open to participants now.
This study's enrollment of 62 is below the median of 99 across 429 interventional studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →East Carolina University is the lead sponsor of 83 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
Received the current standard of care as operationally defined by the investigators- Q\&A session + Video
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.
Score on measure assessing construct of quality of life
Quality of life will be obtained via participants scores from the Medical Outcomes Survey Short Form-12 (SF-12) measure of quality of life.
Time frame: Up to 8 months after enrollment
Score on measure assessing depression
Depression will be assessed via participant's self-reported scores on the depression subscale of the Hospital Anxiety and Depression Scale (HADS).
Time frame: Up to 8 months after enrollment
score on measure assessing construct of patient acceptance of device
The Florida Patient Acceptance Scale measures patient's self-reported acceptance of the implantable cardioverter defibrillator.
Time frame: up to 8 months after enrollment
score on measure assessing anxiety
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.
Time frame: Up to 8 months after enrollment
This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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East Carolina University