Trials / Completed
CompletedNCT00845234
Establishing a Standard for Peri-operative Implantable Cardioverter Defibrillator (ICD) Patient Education
Establishing a Standard for Peri-operative ICD Patient Education: A Demonstration Project
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 62 (actual)
- Sponsor
- East Carolina University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2008-07-01
- Primary completion
- 2011-01-01
- Completion
- 2011-01-01
- First posted
- 2009-02-18
- Last updated
- 2013-02-26
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00845234. Inclusion in this directory is not an endorsement.