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AzTrials

Cardiovascular DiseasesDEMO-CoCoNCT04409210

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

A study testing Establishment of individual health records, Cardiovascular risk assessment and Popularization of medical knowledge in people with Cardiovascular Diseases and Myocardial Ischemia, run by Nanfang Hospital, Southern Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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%. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Establishment of individual health records, Cardiovascular risk assessment and Popularization of medical knowledge
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8,840 participants
Where
1 siteChina
Study dates
20 May 2020to 31 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Jiancheng Xiu, MD contact

86-13903064940

xiujc@126.com

China1 site

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510515

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Establishment of individual health records, Cardiovascular risk assessment, Popularization of medical knowledge, Personalized Reminders, Routine treatment
Medical subject headings
Cardiovascular Diseases, Myocardial Ischemia, Cerebrovascular Disorders, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Establishment of individual health recordsBehavioural

    Also called Establishment

    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 assessmentBehavioural

    Also called 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 knowledgeBehavioural

    Also called Popularization

    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 RemindersBehavioural

    Also called Reminder

    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.

  • Routine treatmentDrug

    Also called Treatment

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

Study groups in NCT04409210
Study groupRoleWhat they receive
Intervention GroupExperimentalThe intervention group will receive establishment of individual health records, cardiovascular risk assessment, popularization of medical knowledge, personalized reminders and routine treatment.
Receives: Behavioral: Establishment of individual health records; Behavioral: Cardiovascular risk assessment; Behavioral: Popularization of medical knowledge; Behavioral: Personalized Reminders; Drug: Routine treatment
Control GroupOtherThe control group just receive routine treatment and routine management.
Receives: Drug: Routine treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 years

Secondary outcomes (9)

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

    Such as hypertension, type 2 diabetes and dyslipidemia and so on.

    Measured: 3 years

  2. Number of Subjects with Major Adverse Cardiovascular Events.

    All-cause mortality, acute heart failure, recurrent myocardial infarction, cardiac death and cerebrovascular death.

    Measured: 3 years

  3. Health-related Quality of Life

    Health-related quality of life will be measured by EuroQol- 5 Dimension (EQ-5D) scale.

    Measured: 6 months

  4. Medication Adherence

    It will be measured by the eight-item Morisky Medication Adherence Scale (MMAS-8).

    Measured: 6 months

  5. Number of Subjects with New-onset Atrial Fibrillation or Atrial Flutter

    Atrial fibrillation or atrial flutter diagnosed by electrocardiogram during follow-up.

    Measured: 3 years

  6. Number of Subjects with Peripheral artery disease

    Including aortic dissection, aortic aneurysm, and significant stenosis of carotid or other peripheral arteries requiring revascularization.

    Measured: 3 years

  7. 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.

    Measured: 3 years

  8. 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.

    Measured: 3 years

  9. Newly diagnosed malignant tumor

    Malignant tumors confirmed by pathology during follow-up.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2020
  2. Study start20 May 2020 (estimated)
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
8,840 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04409210
Sponsor's protocol ID
NFEC-2020-072
Acronym
DEMO-CoCo
Status last verified
May 2020
First submitted
27 May 2020
Last updated
1 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 34741536

  • 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.

    PubMed 33769555

Questions about this trial

What is this clinical trial studying?

A study testing Establishment of individual health records, Cardiovascular risk assessment and Popularization of medical knowledge in people with Cardiovascular Diseases and Myocardial Ischemia, run by Nanfang Hospital, Southern Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jiancheng Xiu, MD (86-13903064940, xiujc@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Atherosclerotic Cardio-cerebrovascular Events (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04409210, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2020.

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