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

NCT04409210 | Unknown

• 1 other identifier: NFEC-2020-072
• Study Type: interventional
• Target: 8,840
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Number of New Acquired High Risk Factors of Cardiovascular and Cerebrovascular Diseases.

  3 years

• 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 New-onset Atrial Fibrillation or Atrial Flutter

  3 years

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

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

Control Group

OTHER

The control group just receive routine treatment and routine management.

Drug: Routine treatment

Interventions

Establishment of individual health records BEHAVIORAL

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.

Also known as: Establishment

Intervention Group

Cardiovascular risk assessment BEHAVIORAL

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.

Also known as: Assessment

Intervention Group

Popularization of medical knowledge BEHAVIORAL

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.

Also known as: Popularization

Intervention Group

Personalized Reminders BEHAVIORAL

1. 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. 2. 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. 3. 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.

Also known as: Reminder

Intervention Group

Routine treatment DRUG

Family physicians conduct the corresponding treatment and management according to the diagnosis and conditions of the patients.

Also known as: Treatment

Control Group; Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Systolic Blood Pressure ≥ 160mmHg or Diastolic Blood Pressure ≥ 100mmHg,
• BMI≥28kg/m2,
• Non- HDL-C≥5.2mmol/L,
• Smoking,
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• The Seventh Affiliated Hospital, Southern Medical University: collaborator

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

Related Publications (2)

• 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.

  PMID: 34741536 DERIVED

• 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.

  PMID: 33769555 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Myocardial Ischemia; Cerebrovascular Disorders; Stroke

Interventions

Restraint, Physical; Therapeutics

Condition Hierarchy (Ancestors)

Heart Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Behavior Control; Immobilization; Investigative Techniques

Study Officials

• Jiancheng Xiu, MD

  Department of Cardiology, Nanfang Hospital, Southern Medical University

  STUDY CHAIR

Central Study Contacts

Jiancheng Xiu, MD

CONTACT

86-13903064940; xiujc@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 1, 2020
• Study Start: May 20, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 1, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)