High-Risk Stroke PopulationSEEDNCT06816238
Smart Education for MACE Prevention and Early Detection
A study testing Interactive education and Traditional health education in people with High-Risk Stroke Population, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
With its high incidence, recurrence, disability, and mortality, stroke has become a significant health challenge in society today. However, "stroke can be prevented and treated," and high-risk groups for stroke are the primary beneficiaries of stroke prevention and control measures. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- High-Risk Stroke Population
- What is being tested?
- Interactive education and Traditional health education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87,376 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2025to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Individuals who meet the definition of a stroke risk group, including those with hypertension, dyslipidemia, diabetes, atrial fibrillation, valvular heart disease, a history of smoking, significant overweight or obesity, physical inactivity, a family history of stroke, or any combination of 8 or more stroke risk factors.
- Individuals with a history of one or more transient ischemic attacks (TIAs) or a previous stroke.
- Legal capacity to provide informed consent. Permanent residents of Zhejiang Province with Zhejiang Provincial household registration.
- Ownership of a smartphone and access to the Alipay app. Voluntary participation and adherence to the principles of informed consent.
Who cannot join
- Illiteracy or difficulty with reading/communication. Medical personnel. Inability to complete the study questionnaire due to physical or cognitive limitations.
About this study
Official title: Smart Education for Major Adverse Cardiovascular Events Prevention and Early Detection
With its high incidence, recurrence, disability, and mortality, stroke has become a significant health challenge in society today. However, "stroke can be prevented and treated," and high-risk groups for stroke are the primary beneficiaries of stroke prevention and control measures. Yet, these populations often have low awareness of proper stroke prevention and treatment knowledge. The reasons for this may include limited coverage, lack of accessibility, inadequate relevance, and uneven content quality in traditional health education measures.
To address these issues, innovative intervention strategies are needed to explore more effective health education methods. The occurrence of Major Adverse Cardiovascular Events (MACE), such as stroke, can be reduced by improving the knowledge and practical abilities of high-risk populations regarding scientific stroke prevention and treatment. One such strategy is the use of smartphone-based information software, which can break the constraints of time and space, delivering health education knowledge to a broader audience. To enhance accessibility, key knowledge points can be repeatedly delivered to the target population through one-way push notifications and interactive Q\&A, allowing for more engaging and flexible learning. In terms of improving pertinence, it is essential to tailor health education delivery to the individual needs of the educatees, considering factors such as age, education level, and risk factors. Furthermore, the quality of health education content must be authoritative, scientifically accurate, easy to understand, and practically applicable. The content should be based on the latest scientific research and professional medical practice, reviewed by authoritative institutions or experts, and should align with the needs of the educated populations for self-health management. Additionally, human and financial costs should be considered when designing such interventions.
In this study, a large-scale medical model based on a stroke prevention and treatment knowledge base, integrated with an intelligent medical system and interactive Q\&A, is employed. This approach ensures content quality while minimizing the need for additional manpower in education and Q\&A, making the intervention more cost-effective and scalable for widespread use. The purpose of this study is to explore whether the incidence of MACE in a high-risk stroke population receiving interactive medical model education-based on a stroke prevention and treatment knowledge base-is lower than in a group without such interactive education.
Read the detailed description
With its high incidence, recurrence, disability and mortality, stroke has become an important health challenge facing the society at present. However, "stroke can be prevented and treated," and high-risk groups of stroke are the main beneficiaries of stroke prevention and control and the intervention targets of "health education" measures. Yet, their awareness of correct stroke prevention and treatment knowledge is low. The reasons may be related to the limited coverage, lack of accessibility, lack of pertinence, and uneven content quality of traditional health education measures.
Therefore, we need to adopt innovative intervention strategies to overcome these constraints and explore effective ways of health education. The occurrence of Major Adverse Cardiovascular Events (MACE), such as stroke, can be reduced by improving the knowledge level and practical ability of scientific stroke prevention and treatment in high-risk populations. In this study, the intervention is based on a large medical model using a medical intelligent agent for interactive Q\&A. This approach is designed to enhance popularization, accessibility, pertinence, and content quality.
Popularization: The use of smartphone-based information software can break through the limitations of time and space, conveying health education knowledge to a wider audience.
Accessibility: Key knowledge points can be repeatedly delivered to the target audience through one-way pushes of health education content, complemented by interactive Q\&A with intelligent medical agents.
Pertinence: Health education content is personalized based on the individual's age, education level, risk factors, and other personal characteristics, ensuring relevance to each educatee.
Content Quality: The educational content is authoritative, scientifically accurate, easy to understand, and practical, drawing from the latest scientific research and professional medical practices, reviewed by authoritative experts and institutions. The intervention ensures that the educated's needs for self-health management are fully considered.
This model leverages the large medical knowledge base and intelligent medical agents to provide personalized, scalable, and cost-effective education, which eliminates the need for additional manpower in education and Q\&A. This approach helps reduce costs while enabling large-scale implementation.
The purpose of this study was to explore whether the incidence of MACE in high-risk stroke populations receiving interactive education based on a medical knowledge model and intelligent Q\&A is lower than that in a group without such education.
- Conditions
- High-Risk Stroke Population
- Being tested
- Interactive education, Traditional health education
- Keywords
- Stroke Prevention, Interactive Education, Medical Knowledge Model, Intelligent Medical Agents, MACE Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive educationOther
interactive education based on a medical knowledge model, utilizing intelligent medical agents and interactive Q\&A
Traditional health educationOther
traditional health education methods without the use of the interactive medical model and intelligent Q\&A system
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | High-risk stroke population receiving interactive education based on a medical knowledge model, utilizing intelligent medical agents and interactive Q\&A. The educational content will cover stroke prevention and treatment, tailored to individual risk factors and needs. Receives: Other: Interactive education |
| Control Group | Active comparator | High-risk stroke population receiving traditional health education methods without the use of the interactive medical model and intelligent Q\&A system. Receives: Other: Traditional health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE Incidence
The occurrence of major adverse cardiovascular events (MACE), including stroke (ischemic or hemorrhagic), myocardial infarction, heart failure, or cardiovascular death, in participants over the 1-year follow-up period. MACE is a composite outcome that captures the broad range of adverse cardiovascular events.
Measured: 1 year from enrollment
Secondary outcomes (10)
Stroke Incidence
The occurrence of new stroke events (ischemic or hemorrhagic) in participants during the 1-year follow-up period.
Measured: 1 year from enrollment
Hospitalization Due to Cardiovascular Events
The number of hospital admissions related to cardiovascular events, including stroke, myocardial infarction, heart failure, or other significant cardiovascular conditions.
Measured: 1 year from enrollment
Stroke Prevention and Treatment Knowledge
Participants' knowledge of stroke prevention and treatment, assessed via surveys or questionnaires.
Measured: 1 year from enrollment
Blood Pressure Control
Proportion of participants maintaining blood pressure within recommended levels (e.g., <140/90 mmHg) as part of stroke and cardiovascular risk management.
Measured: 1 year from enrollment
Physical Function and Quality of Life (QoL)
Assessment of physical function and overall quality of life, measured using standardized scales like the EQ-5D or the SF-36, to understand the impact of the intervention on the participant's daily living and wellbeing.
Measured: 1 year from enrollment
Adherence to Stroke Prevention Medications
Proportion of participants adhering to prescribed medications (e.g., antihypertensives, antiplatelets) for stroke prevention, measured via self-reports or pharmacy refill data.
Measured: 1 year from enrollment
Smoking Cessation (for smokers)
Proportion of smokers who quit smoking within 3 months of the intervention, as assessed by self-report and/or biochemical validation (e.g., carbon monoxide levels, cotinine levels).
Measured: 1 year from enrollment
Weight Loss (for overweight participants)
Proportion of overweight participants who lose at least 5% of their body weight within 3 months, measured via weight records.
Measured: 1 year from enrollment
Sense of First Aid for Stroke
Improvement in participants' knowledge and confidence in providing first aid in the event of a stroke, measured through a standardized questionnaire or skills assessment.
Measured: 1 year from enrollment
Thrombolysis Use in Ischemic Stroke
Proportion of ischemic stroke patients who receive thrombolysis treatment (IV tPA or intra-arterial therapy) within the recommended time window.
Measured: 1 year from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-Risk Stroke PopulationStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87,376 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06816238
- Sponsor's protocol ID
- SEED
- Acronym
- SEED
- Status last verified
- Jan 2025
- First submitted
- 4 Feb 2025
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Education for Major Adverse Cardiovascular Events Prevention and Early Detection
- ClinicalTrials.gov ID
- NCT06816238
- Acronym / sponsor ID
- SEED / SEED
- Conditions
- High-Risk Stroke Population
- Keywords
- Stroke Prevention, Interactive Education, Medical Knowledge Model, Intelligent Medical Agents, MACE Reduction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 87,376 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With its high incidence, recurrence, disability, and mortality, stroke has become a significant health challenge in society today. However, "stroke can be prevented and treated," and high-risk groups for stroke are the primary beneficiaries of stroke prevention and control measures. Yet, these populations often have low awareness of proper stroke prevention and treatment knowledge. The reasons for this may include limited coverage, lack of accessibility, inadequate relevance, and uneven content quality in traditional health education measures.
To address these issues, innovative intervention strategies are needed to explore more effective health education methods. The occurrence of Major Adverse Cardiovascular Events (MACE), such as stroke, can be reduced by improving the knowledge and practical abilities of high-risk populations regarding scientific stroke prevention and treatment. One such strategy is the use of smartphone-based information software, which can break the constraints of time and space, delivering health education knowledge to a broader audience. To enhance accessibility, key knowledge points can be repeatedly delivered to the target population through one-way push notifications and interactive Q\&A, allowing for more engaging and flexible learning. In terms of improving pertinence, it is essential to tailor health education delivery to the individual needs of the educatees, considering factors such as age, education level, and risk factors. Furthermore, the quality of health education content must be authoritative, scientifically accurate, easy to understand, and practically applicable. The content should be based on the latest scientific research and professional medical practice, reviewed by authoritative institutions or experts, and should align with the needs of the educated populations for self-health management. Additionally, human and financial costs should be considered when designing such interventions.
In this study, a large-scale medical model based on a stroke prevention and treatment knowledge base, integrated with an intelligent medical system and interactive Q\&A, is employed. This approach ensures content quality while minimizing the need for additional manpower in education and Q\&A, making the intervention more cost-effective and scalable for widespread use. The purpose of this study is to explore whether the incidence of MACE in a high-risk stroke population receiving interactive medical model education-based on a stroke prevention and treatment knowledge base-is lower than in a group without such interactive education.
Detailed description
With its high incidence, recurrence, disability and mortality, stroke has become an important health challenge facing the society at present. However, "stroke can be prevented and treated," and high-risk groups of stroke are the main beneficiaries of stroke prevention and control and the intervention targets of "health education" measures. Yet, their awareness of correct stroke prevention and treatment knowledge is low. The reasons may be related to the limited coverage, lack of accessibility, lack of pertinence, and uneven content quality of traditional health education measures.
Therefore, we need to adopt innovative intervention strategies to overcome these constraints and explore effective ways of health education. The occurrence of Major Adverse Cardiovascular Events (MACE), such as stroke, can be reduced by improving the knowledge level and practical ability of scientific stroke prevention and treatment in high-risk populations. In this study, the intervention is based on a large medical model using a medical intelligent agent for interactive Q\&A. This approach is designed to enhance popularization, accessibility, pertinence, and content quality.
Popularization: The use of smartphone-based information software can break through the limitations of time and space, conveying health education knowledge to a wider audience.
Accessibility: Key knowledge points can be repeatedly delivered to the target audience through one-way pushes of health education content, complemented by interactive Q\&A with intelligent medical agents.
Pertinence: Health education content is personalized based on the individual's age, education level, risk factors, and other personal characteristics, ensuring relevance to each educatee.
Content Quality: The educational content is authoritative, scientifically accurate, easy to understand, and practical, drawing from the latest scientific research and professional medical practices, reviewed by authoritative experts and institutions. The intervention ensures that the educated's needs for self-health management are fully considered.
This model leverages the large medical knowledge base and intelligent medical agents to provide personalized, scalable, and cost-effective education, which eliminates the need for additional manpower in education and Q\&A. This approach helps reduce costs while enabling large-scale implementation.
The purpose of this study was to explore whether the incidence of MACE in high-risk stroke populations receiving interactive education based on a medical knowledge model and intelligent Q\&A is lower than that in a group without such education.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Interactive educationHigh-risk stroke population receiving interactive education based on a medical knowledge model, utilizing intelligent medical agents and interactive Q\&A. The educational content will cover stroke prevention and treatment, tailored to individual risk factors and needs. |
| Control Group | Active comparator | Other: Traditional health educationHigh-risk stroke population receiving traditional health education methods without the use of the interactive medical model and intelligent Q\&A system. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals who meet the definition of a stroke risk group, including those with hypertension, dyslipidemia, diabetes, atrial fibrillation, valvular heart disease, a history of smoking, significant overweight or obesity, physical inactivity, a family history of stroke, or any combination of 8 or more stroke risk factors.
- Individuals with a history of one or more transient ischemic attacks (TIAs) or a previous stroke.
- Legal capacity to provide informed consent. Permanent residents of Zhejiang Province with Zhejiang Provincial household registration.
- Ownership of a smartphone and access to the Alipay app. Voluntary participation and adherence to the principles of informed consent.
Key exclusion criteria (1 listed)
- Illiteracy or difficulty with reading/communication. Medical personnel. Inability to complete the study questionnaire due to physical or cognitive limitations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive educationinteractive education based on a medical knowledge model, utilizing intelligent medical agents and interactive Q\&A | Other | Intervention Group |
| Traditional health educationtraditional health education methods without the use of the interactive medical model and intelligent Q\&A system | Other | Control Group |
Primary outcome
MACE Incidence
Time frame: 1 year from enrollment
The occurrence of major adverse cardiovascular events (MACE), including stroke (ischemic or hemorrhagic), myocardial infarction, heart failure, or cardiovascular death, in participants over the 1-year follow-up period. MACE is a composite outcome that captures the broad range of adverse cardiovascular events.
10 secondary outcomes
Stroke Incidence
Time frame: 1 year from enrollment
Hospitalization Due to Cardiovascular Events
Time frame: 1 year from enrollment
Stroke Prevention and Treatment Knowledge
Time frame: 1 year from enrollment
Blood Pressure Control
Time frame: 1 year from enrollment
Physical Function and Quality of Life (QoL)
Time frame: 1 year from enrollment
Adherence to Stroke Prevention Medications
Time frame: 1 year from enrollment
Smoking Cessation (for smokers)
Time frame: 1 year from enrollment
Weight Loss (for overweight participants)
Time frame: 1 year from enrollment
Sense of First Aid for Stroke
Time frame: 1 year from enrollment
Thrombolysis Use in Ischemic Stroke
Time frame: 1 year from enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive education and Traditional health education in people with High-Risk Stroke Population, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 4 inclusion and 1 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: opening soon, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE Incidence (time frame: 1 year from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2025.