Stroke Clinical Trial
Official title:
Development, Demonstration and Evaluation of Model of Cardiovascular and Cerebrovascular "Co-Prevention and Co-Management" Based on Internet+
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.
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.
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