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NCT Number: NCT06904664

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

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Individualized temperature health risk early warning and risk factor management

Other

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

Temperature health risk early warning

Other

Receive individualized temperature health risk warning through the application

risk factor management

Other

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

Primary outcomes

  1. 1-year recurrence rate of stroke

    Time frame: Intervention at the 1-year

Secondary outcomes

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

    Time frame: Intervention at 3-month, 6-month, 9-month

  2. Cardiovascular system function indicators

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

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

  3. Laboratory examination

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

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

  4. Modified Rankin Scale

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

    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.

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

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

    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.

  6. Risk perception scale of stroke recurrence

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

    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.

  7. Environmental temperature health risk perception assessment 1uestionnaire

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

    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

  8. Stroke health literacy score

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

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

  9. Health status score

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

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

  10. System usability scale

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

Other outcomes

  1. Incidence of adverse cerebrovascular events

    Time frame: Intervention at the 1-year

Study contacts

Contact information is provided by the study sponsor or research team.

Junwei Hao

CONTACT

[email protected]

010-83198277

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Apr 1, 2025
Registry last updated
Sep 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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