The Effects of a CONCOR Smartphone Application on Arrhythmia, Heart Failure Events and Quality of Life in Patients With Congenital Heart Disease: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Composite of arrhythmia and heart failure events
研究概览
简要总结
Life expectancy of children with congenital heart disease (CHD) has increased dramatically during the past years, due to the successes of cardiac surgery. Nearly all of these children with CHD can be operated at young age and more than 90% reach adulthood. However, many adults with CHD are life-long affected by cardiac events, particularly arrhythmias and heart failure, putting them at risk of premature death. These events have a large impact on quality of life of patients and their families and merit life-long hospital visits in a medical center specialized in adult CHD. Especially for adults with CHD patient care with a smartphone is suited because of their young age and chronic condition. So far, data are lacking on smartphone interventions in patients with CHD.
详细描述
The investigators aim to determine feasibility of CONCOR smartphone application management in adults with CHD. Moreover, during a twelve months follow up period the investigators aim to evaluate whether management with a CONCOR smartphone application results in a lower rate of heart failure events and arrhythmia as well as a better quality of life than usual care, because of increased patient awareness, behavioral stimuli, healthy life style reminders and more precise medical treatment.
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
- None
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
- •Adults with CHD being an Academic Medical Center (AMC) patient and/ or patients registered in the Dutch CONCOR registry
- •Owning a smartphone
排除标准
- •Mental retardation and/ or Down syndrome
结局指标
主要结局
Composite of arrhythmia and heart failure events
时间窗: 1 year
次要结局
- Mortality(1 year)
- Medication adherence questionnaire(1 year)
- Quality of life questionnaire(1 year)
- Usability and learnability questionnaire(1 year)
研究者
Mark Schuuring
MD PhD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)