Cardio-Cerebrovascular Co-Prevention and Co-Management Based on Internet+

Not Applicable

• Conditions: Cardiovascular Diseases; Stroke; Myocardial Ischemia; Cerebrovascular Disorders; Internet-Based Intervention
• Interventions: Behavioral: Establishment of individual health records; Behavioral: Cardiovascular risk assessment; Behavioral: Popularization of medical knowledge; Behavioral: Personalized Reminders; Drug: Routine treatment

• Registration Number: NCT04409210
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Study Timeline

• Status Verified: 2020-05
• Study Start: 2020-05-20
• Study First Submitted: 2020-05-27
• Study First Submitted QC: 2020-05-27
• Last Update Submitted: 2020-05-27
• Study First Posted: 2020-06-01
• Last Update Posted: 2020-06-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8840

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Establishment of individual health records	The intervention group will receive establishment of individual health records, cardiovascular risk assessment, popularization of medical knowledge, personalized reminders and routine treatment.
Intervention Group	Personalized Reminders	The intervention group will receive establishment of individual health records, cardiovascular risk assessment, popularization of medical knowledge, personalized reminders and routine treatment.
Intervention Group	Routine treatment	The intervention group will receive establishment of individual health records, cardiovascular risk assessment, popularization of medical knowledge, personalized reminders and routine treatment.
Intervention Group	Cardiovascular risk assessment	The intervention group will receive establishment of individual health records, cardiovascular risk assessment, popularization of medical knowledge, personalized reminders and routine treatment.
Control Group	Routine treatment	The control group just receive routine treatment and routine management.
Intervention Group	Popularization of medical knowledge	The intervention group will receive establishment of individual health records, cardiovascular risk assessment, popularization of medical knowledge, personalized reminders and routine treatment.

Primary Outcome Measures

Name	Time	Method
Rate of Atherosclerotic Cardio-cerebrovascular Events	3 years	Atherosclerotic Cardio-cerebrovascular Event is defined as nonfatal acute myocardial infarction or coronary heart disease death or fatal or nonfatal stroke.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects with Major Adverse Cardiovascular Events.	3 years	All-cause mortality, acute heart failure, recurrent myocardial infarction, cardiac death and cerebrovascular death.
Health-related Quality of Life	6 months	Health-related quality of life will be measured by EuroQol- 5 Dimension (EQ-5D) scale.
Medication Adherence	6 months	It will be measured by the eight-item Morisky Medication Adherence Scale (MMAS-8).
Number of Subjects with Peripheral artery disease	3 years	Including aortic dissection, aortic aneurysm, and significant stenosis of carotid or other peripheral arteries requiring revascularization.
Newly diagnosed malignant tumor	3 years	Malignant tumors confirmed by pathology during follow-up.
Number of New Acquired High Risk Factors of Cardiovascular and Cerebrovascular Diseases.	3 years	Such as hypertension, type 2 diabetes and dyslipidemia and so on.
Number of Subjects with New-onset Atrial Fibrillation or Atrial Flutter	3 years	Atrial fibrillation or atrial flutter diagnosed by electrocardiogram during follow-up.
Dementia or mild cognitive impairment	3 years	Dementia is defined as acquired cognitive decline or mental and behavioral abnormalities that affect work ability or daily life, and cannot be explained by delirium or other mental disorders.; Mild cognitive impairment mainly includes the following four indicators: 1) cognitive impairment was reported by patients or insiders, or by experienced physicians; 2) objective evidence of impairment of one or more cognitive domains (from cognitive tests); 3) the complex instrumental ability of daily life can be slightly impaired, but the ability of daily living can be maintained independently; and 4) the diagnosis of dementia has not been reached.
Consumption of Medical Resources	3 years	The incremental cost-effectiveness ratio of the two groups was calculated to compare the cost-effectiveness of the intervention group and the control group.

Trial Locations

Locations (1)

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China