WEB-based Distress Management Program for Implantable CARdioverter dEfibrillator Patients (WEBCARE) Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 350
- 试验地点
- 11
- 主要终点
- Anxiety
研究概览
简要总结
The implantable cardioverter defibrillator (ICD) is generally well-accepted by patients, but a subgroup experiences increased anxiety and poor quality of life. A web-based behavioral intervention may comprise a novel approach to reduce anxiety and enhance well-being in ICD patients, which may be equally effective and have advantages over more traditional forms of therapy, due to its low-threshold accessibility via the internet.
The purpose of this study is to determine whether patients receiving a behavioral intervention via the internet experience less anxiety and device concerns and improved quality of life compared to patients receiving usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients implanted with a cardioverter-defibrillator (ICD)
- •between 18-75 years of age
- •speaking and understanding Dutch
- •with access to the internet and ability to use the internet
- •providing written informed consent
排除标准
- •a life expectancy less than 1 year
- •a history of psychiatric illness other than affective/anxiety disorders
- •on the waiting list for heart transplantation
- •with insufficient knowledge of the Dutch language
研究组 & 干预措施
Web-based behavioral intervention
干预措施: web-based multifactorial intervention (Behavioral)
Usual care
干预措施: web-based multifactorial intervention (Behavioral)
结局指标
主要结局
Anxiety
时间窗: 52 weeks
Anxiet
时间窗: 26 weeks
次要结局
- Cortisol awakening response(52 weeks)
研究者
Dr. SS Pedersen
Professor of cardiac psychology
Tilburg University