Development, Demonstration and Evaluation of Model of Cardiovascular and Cerebrovascular "Co-Prevention and Co-Management" Based on Internet+
Overview
- Phase
- Not Applicable
- Intervention
- Establishment of individual health records
- Conditions
- Cardiovascular Diseases
- Sponsor
- Nanfang Hospital, Southern Medical University
- Enrollment
- 8840
- Locations
- 1
- Primary Endpoint
- Rate of Atherosclerotic Cardio-cerebrovascular Events
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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:
Exclusion Criteria
- •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.
Arms & Interventions
Intervention Group
The intervention group will receive establishment of individual health records, cardiovascular risk assessment, popularization of medical knowledge, personalized reminders and routine treatment.
Intervention: Establishment of individual health records
Intervention Group
The intervention group will receive establishment of individual health records, cardiovascular risk assessment, popularization of medical knowledge, personalized reminders and routine treatment.
Intervention: Cardiovascular risk assessment
Intervention Group
The intervention group will receive establishment of individual health records, cardiovascular risk assessment, popularization of medical knowledge, personalized reminders and routine treatment.
Intervention: Popularization of medical knowledge
Intervention Group
The intervention group will receive establishment of individual health records, cardiovascular risk assessment, popularization of medical knowledge, personalized reminders and routine treatment.
Intervention: Personalized Reminders
Intervention Group
The intervention group will receive establishment of individual health records, cardiovascular risk assessment, popularization of medical knowledge, personalized reminders and routine treatment.
Intervention: Routine treatment
Control Group
The control group just receive routine treatment and routine management.
Intervention: Routine treatment
Outcomes
Primary Outcomes
Rate of Atherosclerotic Cardio-cerebrovascular Events
Time Frame: 3 years
Atherosclerotic Cardio-cerebrovascular Event is defined as nonfatal acute myocardial infarction or coronary heart disease death or fatal or nonfatal stroke.
Secondary Outcomes
- Number of Subjects with Major Adverse Cardiovascular Events.(3 years)
- Health-related Quality of Life(6 months)
- Medication Adherence(6 months)
- Number of Subjects with Peripheral artery disease(3 years)
- Newly diagnosed malignant tumor(3 years)
- Number of New Acquired High Risk Factors of Cardiovascular and Cerebrovascular Diseases.(3 years)
- Number of Subjects with New-onset Atrial Fibrillation or Atrial Flutter(3 years)
- Dementia or mild cognitive impairment(3 years)
- Consumption of Medical Resources(3 years)