Clinical trial NCT04409210: Cardio-Cerebrovascular Co-Prevention and Co-Management Based on Internet+
Official title: Development, Demonstration and Evaluation of Model of Cardiovascular and Cerebrovascular "Co-Prevention and Co-Management" Based on Internet+
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Diseases
Myocardial Ischemia
Cerebrovascular Disorders
Stroke
Internet-Based Intervention
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: The Seventh Affiliated Hospital, Southern Medical University
First posted: 2020-06-01
Enrollment: 8840
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization will be performed using a computerized randomization program in a uniform 1:1 allocation ratio for the family physician teams. Patients managed by the same family physician team will be assigned to the same group.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of Atherosclerotic Cardio-cerebrovascular Events
timeFrame: 3 years
Secondary outcomes:
measure: Number of New Acquired High Risk Factors of Cardiovascular and Cerebrovascular Diseases.
timeFrame: 3 years
measure: Number of Subjects with Major Adverse Cardiovascular Events.
timeFrame: 3 years
measure: Health-related Quality of Life
timeFrame: 6 months
measure: Medication Adherence
timeFrame: 6 months
measure: Number of Subjects with New-onset Atrial Fibrillation or Atrial Flutter
timeFrame: 3 years
measure: Number of Subjects with Peripheral artery disease
timeFrame: 3 years
measure: Dementia or mild cognitive impairment
timeFrame: 3 years
measure: Consumption of Medical Resources
timeFrame: 3 years
measure: Newly diagnosed malignant tumor
timeFrame: 3 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Department of Cardiology, Nanfang Hospital, Southern Medical University
name: Jiancheng Xiu, MD
role: STUDY_CHAIR
References:
citation: Dibben G, Faulkner J, Oldridge N, Rees K, Thompson DR, Zwisler AD, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2021 Nov 6;11(11):CD001800. doi: 10.1002/14651858.CD001800.pub4.
citation: Palmer MJ, Machiyama K, Woodd S, Gubijev A, Barnard S, Russell S, Perel P, Free C. Mobile phone-based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults. Cochrane Database Syst Rev. 2021 Mar 26;3(3):CD012675. doi: 10.1002/14651858.CD012675.pub3.