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

Stroke Clinical Trial

— DEMO-CoCo  

Official title:

Development, Demonstration and Evaluation of Model of Cardiovascular and Cerebrovascular "Co-Prevention and Co-Management" Based on Internet+

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04409210
• Other study ID #: NFEC-2020-072
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 20, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2020
• Source: Nanfang Hospital of Southern Medical University
• Contact: Jiancheng Xiu, MD
• Phone: 86-13903064940
• Email: xiujc[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 8840
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cerebrovascular Disorders
• Internet-Based Intervention
• Ischemia
• Myocardial Ischemia
• Stroke

Intervention

Behavioral:
• Establishment of individual health records
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. AND then the App can automatically generate health reports to reflect the dynamic changes of the data in the form of charts and whether the data is normal or not. It is convenient for patients to have a clear understanding of their health management, and if there are outliers, they can intervene in time.
• Cardiovascular risk assessment
The China-PAR risk prediction tool can be used to stratify the 10-years atherosclerotic cardiovascular disease (ASCVD) risk. Those with predicted risks of <5%, 5-10%, and =10% could be classified into categories of low-, moderate-, and high-risk for ASCVD, respectively. It is a risk prediction tool for Chinese developed by the team of Professor Gu Dongfeng of Fuwai Hospital of the Chinese Academy of Medical Sciences. When patients are aware of their risk of cardio-cerebrovascular diseases, it is helpful for patients to take the initiative to manage their cardio-cerebrovascular health.
• Popularization of medical knowledge
Health education is divided into nine modules, such as introduction of cardio-cerebrovascular diseases, diet, exercise, sleep, psychology, medicine, cardiopulmonary resuscitation and cardiac self-rescue technology. The presentation of health education includes three modules: text, video and voice. Video and voice modules are more suitable for illiterates or people are inconvenient to read text. It mainly takes into account the fact that most of the high-risk population of cardio-cerebrovascular diseases are the elderly.
• Personalized Reminders
Abnormal data reminder App can automatically judge whether the data is normal. If abnormal data is found, it will inform the patient in red font and remind the patient to consult the doctor in time. Patients can consult their family doctors directly online through App or go to the hospital. Medication reminder After patients upload their own medication information, the App will automatically generate a medication alarm clock to remind patients to take the drugs. Follow-up reminder According to the clinical diagnosis and conditions of patients, make personalized follow-up time. Family physicians could use the App to remind patients to fill in the follow-up form or go to the hospital.

Drug:
• Routine treatment
Family physicians conduct the corresponding treatment and management according to the diagnosis and conditions of the patients.

Locations

Country	Name	City	State
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	Nanhai Hospital, Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Atherosclerotic Cardio-cerebrovascular Events	Atherosclerotic Cardio-cerebrovascular Event is defined as nonfatal acute myocardial infarction or coronary heart disease death or fatal or nonfatal stroke.	3 years
Secondary	Number of New Acquired High Risk Factors of Cardiovascular and Cerebrovascular Diseases.	Such as hypertension, type 2 diabetes and dyslipidemia and so on.	3 years
Secondary	Number of Subjects with Major Adverse Cardiovascular Events.	All-cause mortality, acute heart failure, recurrent myocardial infarction, cardiac death and cerebrovascular death.	3 years
Secondary	Health-related Quality of Life	Health-related quality of life will be measured by EuroQol- 5 Dimension (EQ-5D) scale.	6 months
Secondary	Medication Adherence	It will be measured by the eight-item Morisky Medication Adherence Scale (MMAS-8).	6 months
Secondary	Number of Subjects with New-onset Atrial Fibrillation or Atrial Flutter	Atrial fibrillation or atrial flutter diagnosed by electrocardiogram during follow-up.	3 years
Secondary	Number of Subjects with Peripheral artery disease	Including aortic dissection, aortic aneurysm, and significant stenosis of carotid or other peripheral arteries requiring revascularization.	3 years
Secondary	Dementia or mild cognitive impairment	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.	3 years
Secondary	Consumption of Medical Resources	The incremental cost-effectiveness ratio of the two groups was calculated to compare the cost-effectiveness of the intervention group and the control group.	3 years
Secondary	Newly diagnosed malignant tumor	Malignant tumors confirmed by pathology during follow-up.	3 years