NCT03392259Unknown不适用
Prospective Validation of Usefulness in Cardiovascular Disease (CVD) Management With CVD Management Solution Based on Interconnection to Hospital Examination
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 666
- 试验地点
- 2
- 主要终点
- Change of 10-year ASCVD risk (10-year ASCVD risk at 6 months - 10-year ASCVD risk at baseline)
研究概览
简要总结
We previously developed the smartphone app (Heart4U) which is coupled with electronic medical record system in Seoul National University Bundang Hospital. In this study, we aim to evaluate clinical usefulness of smartphone app regarding the control of conventional risk factors in patients with history of cardiovascular disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with atherosclerotic cardiovascular diseae
- •history of cardiovascular disease (acute myocardial infarction, unstable angina, stable angina)
- •history of revascularization including percutaneous coronary intervention, peripheral angioplasty or bypass surgery
- •history of stroke
- •history of peripheral arterial disease presumed to be of atherosclerotic origin
- •Patients who have smartphone and can use app by themselves
- •Patients who can speak and read Korean language
排除标准
- •Patients with evidences of delirium, confusion or impaired consciousness
- •Patients who are not familiar to smartphone or app
- •Patients who are not supposed to follow the study protocol adequately.
研究组 & 干预措施
App group
Experimental
conventional treatment + use of smartphone app.
干预措施: Smartphone app (Behavioral)
Control group
No Intervention
conventional treatment
结局指标
主要结局
Change of 10-year ASCVD risk (10-year ASCVD risk at 6 months - 10-year ASCVD risk at baseline)
时间窗: 6 months
delta 10-year ASCVD risk between baseline and 6months, %
次要结局
- Systolic blood pressure(3 & 6 months)
- App service satisfaction survey(6 months)
- degree of moderate physical activity(6 months)
- Diastolic blood pressure(3 & 6 months)
- lipid profiles (total cholesterol, LDL, HDL)(6 months)
- body mass index(6 months)
- smoking rate(6 months)
- drug compliance(6 months)
- depression scale questionnaire(6 months)
研究者
Jung-Won Suh
Professor
Seoul National University Hospital
研究点 (2)
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