Remote Blood Pressure Management Clinical Application Research
试验速览
- 阶段
- 不适用
- 入组人数
- 1,050
- 试验地点
- 1
- 主要终点
- Cardiovascular risk assessment
研究概览
简要总结
Recruit patients with essential hypertension and randomly divide them into three groups. For 24 months, observe the patient's blood pressure level and blood pressure compliance rate,Risk assessment, etc.
详细描述
Recruit patients with essential hypertension and randomly divide them into three groups. One group through remote blood pressure management platform realizes functions such as automatic upload of patient measurement data, intelligent analysis, and early warning reminders;One group is distributed a set of electronic sphygmomanometers , and the blood pressure is recorded by themselves following routine community hypertension management; one group follows routine community hypertension management. For 24 months, observe the patient's blood pressure level and blood pressure compliance rate,Risk assessment, etc. The main technical difficulties and problems to be solved: Widely popularize remote blood pressure based on "Cloud Sharing Smart Cabinet" Management mode. Innovation point: Provide primary hospitals with an intelligent, simple and efficient innovative tool for the management of residents chronic diseases, and improve the management level of chronic diseases in my country promotly; adopt intelligent terminal equipment to realize automatic data collection and transmission to ensure patient real blood pressure data timely and continuously, providing data reference and basis for academic research and the prevention and treatment of chronic diseases, and promoting scientific research in the prevention and treatment of chronic diseases in my country.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of primary hypertension
- •Must be aged at ≥18 years old and ≤75 years old
- •Must have a smart phone and have the ability to use smart devices
- •Must be local permanent resident population who volunteered to participate in the study and received a 2-year follow-up
- •Must sign informed consent
排除标准
- •Participated in other clinical trials within 4 weeks before the start of this study
- •The systolic blood pressure in the office was ≥180 mmHg, and/or the diastolic blood pressure was ≥110 mmHg
- •Uremia, creatinine>250umol/l
- •History of acute heart disease in the past three months
- •Terminal diseases such as malignant tumors
- •Severe cognitive impairment
- •Severe diabetes patients (glycated hemoglobin>11%)
- •Severe valvular heart disease, cardiomyopathy, and poor heart function
- •Atrial fibrillation and atrioventricular block
- •Arm circumference >35cm or <26cm
- •Spouse or relatives have been included in this research
- •Pregnant or breastfeeding women
- •Live in an unfixed state
结局指标
主要结局
Cardiovascular risk assessment
时间窗: 2years
Cardiovascular risk assessment
Blood pressure compliance rate(SBP and DBP)
时间窗: 2years
Blood pressure compliance rate(SBP and DBP)
Blood pressure level(SBP and DBP)
时间窗: 2years
Blood pressure level(SBP and DBP)
Economic benefit
时间窗: 2years
Compare economic benefit among the three groups by counting the cost of hypertension treatment and the cost of hospitalization due to complications of hypertension of patients in every group.
improved level of quality of life
时间窗: 2years
Compare improved level of quality of life among the three groups by counting the proportions of patients with improvement of lifestyle and living habits in every group.The content of improvement of lifestyle and living habits mainly including reduction of the frequency and amount of smoking, drinking, high-salt diet and high-fat diet, increase of the frequency and amount of exercise, and so on.
Therapeutic compliance
时间窗: 2years
Compare therapeutic compliance among the three groups by counting the proportions of patients taking medication on time and regularly receiving follow-up at office in every group.
Clinical prognosis assessment
时间窗: 2years
Compare clinical prognosis among the three groups by counting incidence of non-fatal acute myocardial infarction, non-fatal stroke, hospitalization for unstable angina, hospitalization for worsening heart failure in every group.
次要结局
未报告次要终点