Development, Demonstration and Evaluation of Model of Cardiovascular and Cerebrovascular "Co-Prevention and Co-Management" Based on Internet+

Nanfang Hospital, Southern Medical University1 个研究点分布在 1 个国家目标入组 8,840 人开始时间: 2020年5月20日最近更新: 2020年6月1日

适应症

干预措施

试验速览

阶段: 不适用
发起方: Nanfang Hospital, Southern Medical University
入组人数: 8,840
试验地点: 1
主要终点: Rate of Atherosclerotic Cardio-cerebrovascular Events

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Coronary heart disease and stroke are belong to the atherosclerotic vascular disease (ASCVD). When both occur at the same time, the mortality rate is 19%-37%. Especially when ischemic stroke occurs in patients with acute myocardial infarction, the mortality rate is as high as 36.5%. At present, there is a lack of co-management for the cardio-cerebrovascular diseases. Some studies have explored the disease management based on Internet +, but there are still challenges in personalized management and improving adherence. Based on Internet + 's "co-prevention and co-management" model of cardio-cerebrovascular diseases, this study plans to provide personalized intervention by smartphone App to improve the patients' self-management, in order to reduce the incidence and mortality of atherosclerotic cardio-cerebrovascular events in the high-risk population of cardio-cerebrovascular diseases.

详细描述

The open label, cluster randomized, controlled clinical trial to evaluate the efficacy of smartphone App in the management of the high-risk population of cardio-cerebrovascular diseases. The trial with 2 main objectives: (1) to provide personalized intervention by smartphone App to improve the patients' self-management at least 6 months and (2) to determine whether the "co-prevention and co-management" model based on Internet + for at least 3 years is superior to routine management model at least 3 years on the outcomes of the incidence and mortality of atherosclerotic cardio-cerebrovascular events in the high-risk population of cardio-cerebrovascular diseases.

The trial plans to enroll around 8840 patients in four family physician teams. The four teams will be randomly assigned at 1:1 to the intervention group or the control group. Patients are assigned related group according to their family physician. All patients need to complete the questionnaire and clinical examination. Family physicians and patients in the intervention group need to use the smartphone App of this study, doctors use App to provide personalized health education, risk assessment, follow-up and reminders to patients. At the same time, patients could upload self-test data (such as blood pressure, blood glucose, heart rate and weight) and medical institution examination data (such as blood lipids, ECG, echocardiography, etc.) through App, while receiving routine treatment. Patients in the control group just receive routine treatment and routine management.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Health Services Research
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

•Family physician teams:
•The number of residents served is more than 30,000;
•The proportion of high-risk population of cardio-cerebrovascular diseases is more than 8%;
•manage the health records of residents;
•have a health examination for the residents once a year;
•Family doctors have smartphones.
•Participants:
•Aged ≥18 years;
•Meet any of the following indicators:
•LDL-C>4.9mmol/L or TC>7.2mmol/L; 2) Diabetic patients (age >40 years old): 1.8mmol/L≤LDL-C<4.9mmol/L（or）3.1mmol/L≤TC<7.2mmol/L; 3) The predicted risks measured by China-PAR model of ≥10%; 4) Patients with predicted risks measured by China-PAR model of ≥5% and <10%, and meet with two or more risk factors as following:
•Systolic Blood Pressure ≥ 160mmHg or Diastolic Blood Pressure ≥ 100mmHg,
•BMI≥28kg/m2,
•Non- HDL-C≥5.2mmol/L,
•HDL-C<1.0mmol/L. (3) Local permanent residents (more than 5 years); (4) No severe physical disability, clear consciousness and normal communication; (5) The participants in the intervention group or their families have smartphones; (6) Disease and death are under the management of the local health department; (7) Sign the informed consent form voluntarily.

排除标准

•Family physician teams:
•The establishment of residents' health records is incomplete;
•The main population served are temporary residents and floating population.
•Participants:
•Temporary residents and floating population;
•Those who have serious health conditions and are unable to participate in this study;
•Those who are unwilling to accept the follow-up inspection;
•According to the judgment of the researchers, it is not suitable to participate.