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| Name | Class |
|---|---|
| Aurora Denver Cardiology Associates | UNKNOWN |
| Medtronic | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care Group | No Intervention | Received the current standard of care as operationally defined by the investigators- Q&A session + Video | |
| Intervention Group | Experimental | Intervention group- Patients will receive the brief educational CBT intervention + video and Q&A session |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 8 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Up to 8 months after enrollment |
| score on measure assessing construct of patient acceptance of device |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel F Sears, Ph.D. | East Carolina University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aurora Denver Cardiology Associates | Aurora | Colorado | 80012 | United States | ||
| Aurora Denver Cardiology Associates |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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|
The Florida Patient Acceptance Scale measures patient's self-reported acceptance of the implantable cardioverter defibrillator. |
| 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. | Up to 8 months after enrollment |
| Lone Tree |
| Colorado |
| 80124 |
| United States |
| East Carolina Heart Institute | Greenville | North Carolina | 27834 | United States |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |