NCT Number: NCT00845234
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Aurora Denver Cardiology Associates, Aurora, Colorado, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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).
Time frame: up to 8 months after enrollment
The Florida Patient Acceptance Scale measures patient's self-reported acceptance of the implantable cardioverter defibrillator.
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.
East Carolina University
Other
Establishing a Standard for Peri-operative ICD Patient Education: A Demonstration Project
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT00847132
Arrhythmia, Arrhythmias, Cardiac
Boston, Massachusetts, United States
View Trial DetailsNCT00006311
Arrhythmia, Arrhythmias, Cardiac
View Trial DetailsNCT07728552
Arrhythmia, Arrhythmias, Cardiac
Seoul, South Korea
View Trial DetailsNCT06381245
Arrhythmia, Arrhythmias, Cardiac
Warsaw, Poland
View Trial Details