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AzTrials

Acute Ischemic StrokeNCT06904664

An Application That Can Provide Early Warning of Temperature Health Risks and Give Protective Suggestions or Personalized Suggestions Based on Patients' Own Secondary Prevention Risk Factors Was Applied to Intervene, and the Intervention Effect of APP on Stroke Recurrence Risk Was Analyzed

A study testing Individualized temperature health risk early warning and risk factor management, Temperature health risk early warning and Risk factor management in people with Acute Ischemic Stroke, run by Xuanwu Hospital, Beijing.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study employs individualized temperature health risk early warning and risk factor management interventions for stroke, and explores their actual intervention effects. This enables patients to promptly understand their own risk levels and take corresponding protective measures, thereby enhancing the management… Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Acute Ischemic Stroke
What is being tested?
Individualized temperature health risk early warning and risk factor management, Temperature health risk early warning and Risk factor management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10,184 participants
Where
No sites listed yet
Study dates
1 Sep 2025to 31 Aug 2028
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 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 40 to 80, with no gender restrictions;
  • Acute ischemic stroke inpatients within 2 weeks of onset, where the onset time is the time when stroke symptoms appear or the last known normal time of the patient (when it is an onset during sleep or the symptom onset time cannot be accurately obtained due to aphasia, impaired consciousness, etc.); ③ Confirmed diagnosis of ischemic stroke by CT or MRI of the brain within 2 weeks after symptom onset;
  • Local residents (residing for ≥6 months); ⑤ Patients who voluntarily participate in the study, have high compliance, and can sign the informed consent form;
  • Patients who own a smartphone or other smart devices.

Who cannot join

  • Patients diagnosed with other cerebrovascular diseases (hemorrhagic stroke, transient ischemic attack, cerebral venous sinus thrombosis, etc.) or non-cerebrovascular diseases;
  • Known pregnant or lactating women, or those who tested positive on a pregnancy test before cluster randomization;
  • Patients with other conditions that may affect participation in the trial (e.g., refractory hypertension, severe aphasia, etc.);
  • Patients undergoing psychiatric/psychological treatment that may contaminate the results; ⑤ Patients with a life expectancy of less than one year (e.g., coexisting malignant tumors, severe cardiopulmonary diseases, etc.); ⑥ Patients already participating in other interventional clinical studies that may influence the outcome assessment; ⑦ Patients for whom the investigator deems unsuitable for participation in this study or who may pose significant risks to the patients (e.g., cognitive impairment preventing understanding and/or compliance with the study procedures and/or follow-up).

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Junwei Hao contact

010-83198277

haojunwei@vip.163.com

About this study

Official title: Individualized Temperature Health Risk Early Warning and Risk Factor Management App for Reducing the Recurrence Risk of Stroke: A Multicenter, Randomized Controlled Trial Study

This study employs individualized temperature health risk early warning and risk factor management interventions for stroke, and explores their actual intervention effects. This enables patients to promptly understand their own risk levels and take corresponding protective measures, thereby enhancing the management outcomes and quality of life. The study also promotes the interdisciplinary integration of environmental epidemiology and clinical intervention management, providing new ideas and methodological support for future relevant research.

Being tested
Individualized temperature health risk early warning and risk factor management, Temperature health risk early warning, Risk factor management
Medical subject headings
Ischemic Stroke

What participants receive

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

  • Individualized temperature health risk early warning and risk factor managementOther

    Receive individualized temperature health risk warning and prevention risk factor management information for stroke through the application

  • Temperature health risk early warningOther

    Receive individualized temperature health risk warning through the application

  • Risk factor managementOther

    Receive individualized prevention risk factor management information for stroke through the application

Study groups in NCT06904664
Study groupRoleWhat they receive
Enhanced intervention groupExperimentalReceive individualized temperature health risk warning and prevention risk factor management information for stroke through the application
Receives: Other: Individualized temperature health risk early warning and risk factor management
Temperature health risk early warning groupExperimentalReceive individualized temperature health risk warning through the application
Receives: Other: Temperature health risk early warning
Risk factor management groupExperimentalReceive individualized prevention risk factor management information for stroke through the application
Receives: Other: Risk factor management
Routine education groupNo interventionOnly receive routine health education, without receiving individualized temperature health risk warning or prevention risk factor management information for stroke through the application

What is being measured

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

  1. 1-year recurrence rate of stroke

    Measured: Intervention at the 1-year

Secondary outcomes (10)

  1. 3-month, 6-month, 9-month recurrence rate of stroke

    Measured: Intervention at 3-month, 6-month, 9-month

  2. Cardiovascular system function indicators

    Such as blood pressure, various electrocardiogram indicators and other examination results that can reflect cardiovascular function

    Measured: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year

  3. Laboratory examination

    Such as results of laboratory tests including lipid profiles, blood glucose, coagulation, and other laboratory indicators.

    Measured: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year

  4. Modified Rankin Scale

    The Modified Rankin Scale (mRS) is a scale used to assess the neurological recovery status and disability level in stroke patients. The scale ranges from zero to six, divided into seven levels, with higher grades indicating worse conditions.

    Measured: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year

  5. European five-dimensional five-level Health Scale score

    The scale includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with each dimension containing five levels. It also includes a 0-100 scale, where a lower score indicates worse condition.

    Measured: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year

  6. Risk perception scale of stroke recurrence

    The scale uses a Likert three-point scoring method, assigning values of 1, 2, and 3 for the responses "disagree," "uncertain," and "agree," respectively. A higher score indicates a higher level of perceived ability.

    Measured: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year

  7. Environmental temperature health risk perception assessment 1uestionnaire

    Here are multiple questions related to environmental risk factors and health risks, each using a 0-100 scale where a higher score indicates greater understanding

    Measured: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year

  8. Stroke health literacy score

    The scale uses a five-point scoring method, with a higher score indicating a higher level of stroke health literacy.

    Measured: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year

  9. Health status score

    Such as barthel index (BI) and other scoring scales for evaluating patients' disease recovery, physical condition and other abilities

    Measured: Baseline; Intervention at 3-month, 6-month, 9-month and 1-year

  10. System usability scale

    Measured: Intervention at 3-month, 6-month, 9-month and 1-year

Timeline

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

  1. First posted1 Apr 2025
  2. Study start1 Sep 2025 (estimated)
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Aug 2028 (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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
10,184 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06904664
Sponsor's protocol ID
[2024]444-003-1-3
Status last verified
Sep 2025
First submitted
18 Mar 2025
Last updated
5 Sep 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Individualized temperature health risk early warning and risk factor management, Temperature health risk early warning and Risk factor management in people with Acute Ischemic Stroke, run by Xuanwu Hospital, Beijing.

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 4 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 5 Sep 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?

Contact Junwei Hao (010-83198277, haojunwei@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1-year recurrence rate of stroke (time frame: Intervention at the 1-year). 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 NCT06904664.

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 5 Sep 2025.

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