Northern Jiangsu Province People's Hospital
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- The incidence of ischemic stroke
研究概览
简要总结
Atrial fibrillation (AF) is one of the most common arrhythmias. Its repeated fluctuations in ventricular rate and irregular heart rhythm not only reduce exercise tolerance and quality of life, but also cause hemodynamic changes. The incidence of stroke is increased by 5 times or more compared with the average person. According to statistics, the annual mortality rate from stroke due to atrial fibrillation is about 20%-25%. Of course, like other cardiovascular diseases, atrial fibrillation occurs in a large proportion of the elderly population. According to statistics, 80% of patients with atrial fibrillation are 65 years of age or older. With the aging of the world's population, especially in the 21st century, the proportion of patients with atrial fibrillation has increased year by year. The treatment of atrial fibrillation involves many aspects such as switching to sinus rhythm, controlling heart rate and anticoagulant therapy, which is a long course affecting the adherence of AF patients. AF is a kind of disease that can be preventable and controllable. The out-of-hospital care for AF patients has been proved to reduce the mortality and unexpected readmission rate, but there are still high costs, poor compliance, low management efficiency and etc. Telemedicine was believed to solve these problems to further reduce the mortality of AF patients. The latest ESC Heart Failure Guidelines emphasis the significance of telemedicine in AF, however, it didn't provide a standardized AF remote management system.
详细描述
Subjects with Hospital-Community-Family-Care Management Platform online and those with the clinic follow up. In the program, participants were educated on the use of smart health-tracking devices and mobile application (APP) to collect and upload comprehensive data elements related to the risk of AF self-care management. They were also instructed to send text messages, view notifications, and receive individualized guidance on the mobile APP. The general practitioners viewed index of each participant on mobile APP and provided primary care periodically, and cardiologists in regional central hospital offered remote guidance and management if necessary. Outcomes assessed included accomplishments of the program, usability and satisfaction, engagement with the intervention, and changes of AF-related health behaviors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
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
- •Age ≥ 18 years old;
- •Meeting the diagnostic criteria for atrial fibrillation;
- •Subjects can understand the situation of this study and agree to sign informed consent and continue to follow up.
排除标准
- •Atrial fibrillation caused by reversible causes, including: acute myocardial infarction (MI) within 1 month, acute myocarditis within 1 month, untreated hyperthyroidism, and electrophysiological examination, angiography, atrial fibrillation did not reappear after treatment;
- •There is no recurrence of atrial fibrillation after surgical treatment;
- •Due to other serious diseases, the expected survival time is less than 1 year;
- •Severe liver and kidney disease: serum creatinine>5.0mg/dl; ALT exceeds the reference value by more than 3 times (ALT> 100u/L);
- •Systolic or diastolic blood pressure ≥ 180/110mm Hg (1mm Hg = 0.133kPa), but can be selected after blood pressure control;
- •Diagnosed or suspected blood system diseases (except for mild to moderate anemia) leading to coagulopathy or accompanied by bleeding tendency;
- •Pregnant and lactating women;
- •Reluctance to use remote monitoring equipment (such as depression, dementia, impaired autonomy, lack of communication skills);
- •Participating in other treatment research or remote patient management programs;
- •The investigator consider that it is not suitable for joining the study;
结局指标
主要结局
The incidence of ischemic stroke
时间窗: 2 year
Cardiovascular mortality
时间窗: 2 year
all-cause mortality
时间窗: 2 year
次要结局
- Incidence of severe hemorrhage(2 year)
- Incidence of slight hemorrhage(2 year)
- Usability of the AF telemedicine platform intervention for patients(4 months)
- Incidence of systemic embolism(2 year)
- Incidence of transient ischemic attack(2 year)
- Changes of lifestyles and healthy behaviors(4 months)
- Drug adherence(4 months)
- Engagement of the intervention(4 months)
研究者
Xiang Gu
Director of cardiology
Northern Jiangsu People's Hospital