- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04409210
Cardio-Cerebrovascular Co-Prevention and Co-Management Based on Internet+ (DEMO-CoCo)
Development, Demonstration and Evaluation of Model of Cardiovascular and Cerebrovascular "Co-Prevention and Co-Management" Based on Internet+
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jiancheng Xiu, MD
- Phone Number: 86-13903064940
- Email: xiujc@126.com
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510515
- Nanfang Hospital, Southern Medical University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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:
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:
- 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.
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group
The intervention group will receive establishment of individual health records, cardiovascular risk assessment, popularization of medical knowledge, personalized reminders and routine treatment.
|
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.
Other Names:
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.
Other Names:
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.
Other Names:
Other Names:
Family physicians conduct the corresponding treatment and management according to the diagnosis and conditions of the patients.
Other Names:
|
Other: Control Group
The control group just receive routine treatment and routine management.
|
Family physicians conduct the corresponding treatment and management according to the diagnosis and conditions of the patients.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Atherosclerotic Cardio-cerebrovascular Events
Time Frame: 3 years
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Atherosclerotic Cardio-cerebrovascular Event is defined as nonfatal acute myocardial infarction or coronary heart disease death or fatal or nonfatal stroke.
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3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of New Acquired High Risk Factors of Cardiovascular and Cerebrovascular Diseases.
Time Frame: 3 years
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Such as hypertension, type 2 diabetes and dyslipidemia and so on.
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3 years
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Number of Subjects with Major Adverse Cardiovascular Events.
Time Frame: 3 years
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All-cause mortality, acute heart failure, recurrent myocardial infarction, cardiac death and cerebrovascular death.
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3 years
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Health-related Quality of Life
Time Frame: 6 months
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Health-related quality of life will be measured by EuroQol- 5 Dimension (EQ-5D) scale.
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6 months
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Medication Adherence
Time Frame: 6 months
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It will be measured by the eight-item Morisky Medication Adherence Scale (MMAS-8).
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6 months
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Number of Subjects with New-onset Atrial Fibrillation or Atrial Flutter
Time Frame: 3 years
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Atrial fibrillation or atrial flutter diagnosed by electrocardiogram during follow-up.
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3 years
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Number of Subjects with Peripheral artery disease
Time Frame: 3 years
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Including aortic dissection, aortic aneurysm, and significant stenosis of carotid or other peripheral arteries requiring revascularization.
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3 years
|
Dementia or mild cognitive impairment
Time Frame: 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. |
3 years
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Consumption of Medical Resources
Time Frame: 3 years
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The incremental cost-effectiveness ratio of the two groups was calculated to compare the cost-effectiveness of the intervention group and the control group.
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3 years
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Newly diagnosed malignant tumor
Time Frame: 3 years
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Malignant tumors confirmed by pathology during follow-up.
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3 years
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Collaborators and Investigators
Investigators
- Study Chair: Jiancheng Xiu, MD, Department of Cardiology, Nanfang Hospital, Southern Medical University
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NFEC-2020-072
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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