Back to resultsCardio-Cerebrovascular Co-Prevention and Co-Management Based on Internet+ (DEMO-CoCo)
Primary Purpose
Cardiovascular Diseases, Myocardial Ischemia, Cerebrovascular Disorders
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Establishment of individual health records
Cardiovascular risk assessment
Popularization of medical knowledge
Personalized Reminders
Routine treatment
Sponsored by
About this trial
This is an interventional health services research trial for Cardiovascular Diseases
Eligibility Criteria
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.
Sites / Locations
- Nanfang Hospital, Southern Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention Group
Control Group
Arm Description
The intervention group will receive establishment of individual health records, cardiovascular risk assessment, popularization of medical knowledge, personalized reminders and routine treatment.
The control group just receive routine treatment and routine management.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of New Acquired High Risk Factors of Cardiovascular and Cerebrovascular Diseases.
Such as hypertension, type 2 diabetes and dyslipidemia and so on.
Number of Subjects with Major Adverse Cardiovascular Events.
All-cause mortality, acute heart failure, recurrent myocardial infarction, cardiac death and cerebrovascular death.
Health-related Quality of Life
Health-related quality of life will be measured by EuroQol- 5 Dimension (EQ-5D) scale.
Medication Adherence
It will be measured by the eight-item Morisky Medication Adherence Scale (MMAS-8).
Number of Subjects with New-onset Atrial Fibrillation or Atrial Flutter
Atrial fibrillation or atrial flutter diagnosed by electrocardiogram during follow-up.
Number of Subjects with Peripheral artery disease
Including aortic dissection, aortic aneurysm, and significant stenosis of carotid or other peripheral arteries requiring revascularization.
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.
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.
Newly diagnosed malignant tumor
Malignant tumors confirmed by pathology during follow-up.
Full Information
NCT ID
NCT04409210
First Posted
May 27, 2020
Last Updated
May 27, 2020
Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
The Seventh Affiliated Hospital, Southern Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04409210
Brief Title
Cardio-Cerebrovascular Co-Prevention and Co-Management Based on Internet+
Acronym
DEMO-CoCo
Official Title
Development, Demonstration and Evaluation of Model of Cardiovascular and Cerebrovascular "Co-Prevention and Co-Management" Based on Internet+
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 20, 2020 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
The Seventh Affiliated Hospital, Southern Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Myocardial Ischemia, Cerebrovascular Disorders, Stroke, Internet-Based Intervention
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8840 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
The intervention group will receive establishment of individual health records, cardiovascular risk assessment, popularization of medical knowledge, personalized reminders and routine treatment.
Arm Title
Control Group
Arm Type
Other
Arm Description
The control group just receive routine treatment and routine management.
Intervention Type
Behavioral
Intervention Name(s)
Establishment of individual health records
Other Intervention Name(s)
Establishment
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cardiovascular risk assessment
Other Intervention Name(s)
Assessment
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Popularization of medical knowledge
Other Intervention Name(s)
Popularization
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Personalized Reminders
Other Intervention Name(s)
Reminder
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Routine treatment
Other Intervention Name(s)
Treatment
Intervention Description
Family physicians conduct the corresponding treatment and management according to the diagnosis and conditions of the patients.
Primary Outcome Measure Information:
Title
Rate of Atherosclerotic Cardio-cerebrovascular Events
Description
Atherosclerotic Cardio-cerebrovascular Event is defined as nonfatal acute myocardial infarction or coronary heart disease death or fatal or nonfatal stroke.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Number of New Acquired High Risk Factors of Cardiovascular and Cerebrovascular Diseases.
Description
Such as hypertension, type 2 diabetes and dyslipidemia and so on.
Time Frame
3 years
Title
Number of Subjects with Major Adverse Cardiovascular Events.
Description
All-cause mortality, acute heart failure, recurrent myocardial infarction, cardiac death and cerebrovascular death.
Time Frame
3 years
Title
Health-related Quality of Life
Description
Health-related quality of life will be measured by EuroQol- 5 Dimension (EQ-5D) scale.
Time Frame
6 months
Title
Medication Adherence
Description
It will be measured by the eight-item Morisky Medication Adherence Scale (MMAS-8).
Time Frame
6 months
Title
Number of Subjects with New-onset Atrial Fibrillation or Atrial Flutter
Description
Atrial fibrillation or atrial flutter diagnosed by electrocardiogram during follow-up.
Time Frame
3 years
Title
Number of Subjects with Peripheral artery disease
Description
Including aortic dissection, aortic aneurysm, and significant stenosis of carotid or other peripheral arteries requiring revascularization.
Time Frame
3 years
Title
Dementia or mild cognitive impairment
Description
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.
Time Frame
3 years
Title
Consumption of Medical Resources
Description
The incremental cost-effectiveness ratio of the two groups was calculated to compare the cost-effectiveness of the intervention group and the control group.
Time Frame
3 years
Title
Newly diagnosed malignant tumor
Description
Malignant tumors confirmed by pathology during follow-up.
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiancheng Xiu, MD
Phone
86-13903064940
Email
xiujc@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiancheng Xiu, MD
Organizational Affiliation
Department of Cardiology, Nanfang Hospital, Southern Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34741536
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.
Results Reference
derived
PubMed Identifier
33769555
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.
Results Reference
derived
Learn more about this trial
Cardio-Cerebrovascular Co-Prevention and Co-Management Based on Internet+
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