Establishing a Standard for Peri-operative ICD Patient Education: A Demonstration Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 5
- 主要终点
- Score on measure assessing construct of quality of life
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18+ years old
- •newly implanted with an implantable cardioverter defibrillator (ICD)
排除标准
- •documented neurological sequelae associated with CVA or dementia
- •documented cognitive impairment
- •reported illiteracy
- •previously implanted ICD
结局指标
主要结局
Score on measure assessing construct of quality of life
时间窗: 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.
次要结局
- Score on measure assessing depression(Up to 8 months after enrollment)
- score on measure assessing construct of patient acceptance of device(up to 8 months after enrollment)
- score on measure assessing anxiety(Up to 8 months after enrollment)
研究者
Samuel F. Sears
Professor
East Carolina University