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NCT Number: NCT07098143

An Application Provides Personalized Suggestions Based on Secondary Prevention Risk Factors to Stroke Patients

This study applied an application that provides personalized suggestions and explore the effect of this actual intervention on reducing the risk of stroke recurrence

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

This study applied an application that provides personalized suggestions based on participant's own secondary prevention risk factors status to stroke patients, enabling them to promptly take protective measures. And explore the effect of this actual intervention on reducing the risk of stroke recurrence after one year, as well as changes in other health-related indicators.

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.);
  • Confirmed diagnosis of ischemic stroke by CT or MRI of the brain within 2 weeks after symptom onset; ④ 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.);
  • 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

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. Health literacy scale score

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

    It is used to assess patients' understanding about secondary prevention risk factors. The lower the score, the less they understand or are concerned about it

  3. System usability scale score

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

    It is used to understand the subjects' satisfaction and usability evaluation of the intelligent program. The higher the score, the better the evaluation

  4. Blood pressure

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

    Systolic and diastolic blood pressure will be measured using a standard automated sphygmomanometer

  5. Electrocardiogram (ECG) parameters

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

    Electrocardiogram (ECG) will be performed to assess cardiac electrical activity. Specific parameters will be analyzed, such as heart rate (beats per minute (bpm)), QT interval (milliseconds (ms)), PR interval (milliseconds (ms)), QRS duration (milliseconds (ms))

  6. Fasting blood glucose

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

    Fasting plasma glucose levels will be measured to assess glycemic control

  7. Prothrombin time

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

    Prothrombin time (PT) will be assessed using standard coagulation tests, it reflects the coagulation function, with a reference range of 11.0 to 13.0 seconds

  8. C-reactive protein

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

    Blood samples will be analyzed using immunoassay techniques on automated analyzers

  9. Modified rankin scale score

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

    The functional recovery of patients was evaluated using the modified rankin scale. The higher the score, the more serious it is

  10. NIH stroke scale score

    Time frame: Baseline

    The neurological deficits on the NIHSS scale indicate that the higher the score, the more severe the stroke

  11. European five-dimensional five-level health scale score

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

    It is used to assess an individual's health-related quality of life, consisting of two parts: a questionnaire and a visual analog scale (VAS). The questionnaire includes five dimensions, where higher scores indicate worse health status. The visual analog scale asks respondents to rate their overall health on a 0-100 scale, with higher scores reflecting better self-rated health status.

  12. Minimum mental state examination

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

    It is used to screen patients' cognitive conditions. The lower the score, the worse the cognition

  13. Social support rate scale score

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

    It is used to understand the support that patients receive in society, and the higher the score, the more support they receive

  14. Depression anxiety stress scales - 21 score

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

    It is used to understand the patient's emotional state. The higher the score, the worse the mood

  15. Activated partial thromboplastin time

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

    Activated partial thromboplastin time (aPTT) will be assessed using standard coagulation tests, it reflects the coagulation function, with a reference range of 26.0 to 36.0 seconds, and may vary slightly depending on the reagents or testing techniques used.

  16. International normalized ratio

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

    International normalized ratio (INR) will be assessed using standard coagulation tests, it reflects the coagulation function, ,、 and the reference range for healthy people is 0.8 to 1.2, and may vary slightly depending on the medication or disease status.

  17. Platelet count

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

    Platelet count will be assessed using standard coagulation tests, it reflects the coagulation function, with a reference range of (100～300）×10^9/L.

  18. D-dimer

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

    D-dimer will be assessed using standard coagulation tests, it reflects the coagulation function, with a reference range of <0.3mg/L, and may vary slightly depending on the reagents or testing techniques used.

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 Risk Factor Management Application 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
Aug 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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