Cardio-Cerebrovascular Co-Prevention and Co-Management Based on Internet+ (DEMO-CoCo)

Nanfang Hospital, Southern Medical University

Status: Unknown

Conditions: Myocardial Ischemia; Stroke; Cardiovascular Diseases; Cerebrovascular Disorders; Internet-Based Intervention

Treatments: Behavioral: Establishment of individual health records; Behavioral: Personalized Reminders; Drug: Routine treatment; Behavioral: Popularization of medical knowledge; Behavioral: Cardiovascular risk assessment

Study type: Interventional

Funder types: Other

Identifiers

NCT04409210

NFEC-2020-072

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8,840 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Family physician teams:

1. The number of residents served is more than 30,000;
2. The proportion of high-risk population of cardio-cerebrovascular diseases is more than 8%;
3. manage the health records of residents;
4. have a health examination for the residents once a year;
5. Family doctors have smartphones.

Participants:

1. Aged ≥18 years;
2. Meet any of the following indicators:

1. 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:

1. Systolic Blood Pressure ≥ 160mmHg or Diastolic Blood Pressure ≥ 100mmHg,
2. BMI≥28kg/m2,
3. Non- HDL-C≥5.2mmol/L,
4. Smoking,
5. 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.

Exclusion criteria

Family physician teams:

1. The establishment of residents' health records is incomplete;
2. The main population served are temporary residents and floating population.

Participants:

1. Temporary residents and floating population;
2. Those who have serious health conditions and are unable to participate in this study;
3. Those who are unwilling to accept the follow-up inspection;
4. According to the judgment of the researchers, it is not suitable to participate.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8,840 participants in 2 patient groups

Intervention Group

Experimental group

Description:

The intervention group will receive establishment of individual health records, cardiovascular risk assessment, popularization of medical knowledge, personalized reminders and routine treatment.

Treatment:

Behavioral: Personalized Reminders

Behavioral: Cardiovascular risk assessment

Behavioral: Popularization of medical knowledge

Drug: Routine treatment

Behavioral: Establishment of individual health records

Control Group

Other group

Description:

The control group just receive routine treatment and routine management.

Treatment:

Drug: Routine treatment