Arrhythmia
Conditions
Keywords
behavioral intervention, implantable cardioverter defibrillator, psychosocial education, anxiety, depression
Brief summary
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.
Interventions
BEHAVIORALIntervention
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.
Sponsors
Aurora Denver Cardiology Associates
Medtronic
East Carolina University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score on measure assessing construct of quality of life | 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
| Measure | Time frame | Description |
|---|---|---|
| Score on measure assessing depression | 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 | 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 | 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. |
Countries
United States
Outcome results
None listed