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Starting soon Not applicable

Prevention of Ischemic Stroke Recurrence Using Digital Technology Application

NCT07825311 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-09-01
Last updated
2026-09-17

Condition(s) studied

Ischemic StrokeDigital Health

Investigational drug(s) / intervention(s)

Digital Prevention ManagementUsual Stroke Secondary Prevention Management

Digital Prevention Management: Participants in this arm receive usual stroke secondary prevention management plus a 12-month comprehensive digital intervention consisting of: Wearable Device (Smart Bracelet) + Digital Platform (Mobile Application)

Usual Stroke Secondary Prevention Management: Participants in this arm receive standard care according to current clinical guidelines for stroke secondary prevention.

Study summary

The goal of this study is to find out whether a comprehensive management program that uses a smart bracelet and a mobile app can help people who have had an ischemic stroke (a type of stroke caused by a blocked blood vessel in the brain) to prevent another stroke. The investigators also want to see whether this program helps with controlling blood pressure, blood sugar, and blood lipids, as well as with taking medications correctly, improving daily habits, and supporting emotional well-being.

The investigators are focusing on two main questions:

* After using this digital management tool, will the chance of having another stroke within one year after leaving the hospital be lower?
* Compared with people who only receive regular care, will those who use the tool show better control of blood pressure, blood sugar, and blood lipids, better medication adherence, and healthier lifestyles?

People who join the study will be randomly assigned to one of two groups. One group will receive usual stroke prevention care (the control group). The other group will get the same usual care plus an additional 12-month program that includes a smart bracelet and a mobile app (the intervention group).

If participants are in the intervention group, participants will:

* Wear a smart bracelet continuously and use a mobile app for 12 months.
* Receive health tips, medication reminders, blood-pressure measurement reminders, activity goals, and vibration alerts when participants have been sitting too long through the app.

If participants are in either group, participants will:

* Come to the clinic for check-ups and assessments at the start of the study, and again at 3 months, 6 months, and 12 months.
* Have neurological function of participants, daily activity abilities, quality of life, medication adherence, and mood (depression and anxiety) assessed at those visits.
* Have blood tests to check metabolic risk factors of participants(e.g., blood lipids and glucose) at the same visits.
* Report to the research team if participants experience another stroke, any cardiovascular event, or death at each follow-up visit.

The investigators will compare the two groups to see if the digital program makes a real difference in reducing stroke recurrence and improving overall health after a stroke.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age 18 years or older. * Diagnosed with ischemic stroke within the past 3 months, confirmed by cranial CT or MRI. * Have both hypertension and diabetes as concurrent metabolic risk factors for stroke recurrence. * Possess basic communication skills and ability to understand the study content and provide written informed consent. * The participant or their primary caregiver is able to use a smart wearable device, has access to a smartphone, and is willing to complete follow-up visits as required by the study protocol. Exclusion Criteria: * Life expectancy less than 12 months, or presence of severe cardiac, hepatic, renal, or other systemic diseases that would make participation in follow-up inappropriate. * Severe cognitive impairment, aphasia, psychiatric disorders, or disturbance of consciousness that prevents cooperation with the study, without a stable caregiver to assist. * Severe physical disability or other reasons that preclude wearing or using the wearable device. * Currently participating in another interventional study that may affect stroke recurrence outcomes.

Primary outcome measure(s)

  • Number of Participants With First Recurrent Stroke — From randomization through 12 months
    Recurrent stroke is defined as a new ischemic or hemorrhagic stroke occurring after randomization and confirmed by an independent blinded endpoint adjudication committee based on clinical findings and brain CT or MRI. If a participant experiences more than one recurrent stroke, only the first qualifying event will be counted.

Trial sites (1)

FacilityCityRegionStatus
Affiliated Hospital of Nantong University Nantong Jiangsu
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07825311 on ClinicalTrials.gov ↗ ← All trials in China