Prevention of Ischemic Stroke Recurrence Using Digital Technology Application
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAffiliated Hospital of Nantong University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Digital Prevention Management
DeviceParticipants 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
Other interventionParticipants in this arm receive standard care according to current clinical guidelines for stroke secondary prevention.
Treatment groups
1,696 Participants
are divided into 2 treatment groupsGroup A: Digital Prevention ManagementExperimental treatment 1 intervention
Group B: Usual Stroke Secondary PreventionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants With First Recurrent Stroke
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.
Time frame
From randomization through 12 monthsSecondary outcomes
1
Percentage of Participants Achieving the Prespecified Blood Pressure Target
Blood pressure control is defined as a mean seated systolic blood pressure below 130 mm Hg and a mean seated diastolic blood pressure below 80 mm Hg. Blood pressure will be measured using a validated device after at least 5 minutes of rest. The mean of three measurements obtained at each visit will be used. The outcome will be reported as the percentage of participants meeting both targets.
Time frame
At 3, 6, and 12 months after randomization2
Percentage of Participants Achieving the Prespecified Glycemic Target
Glycemic control is defined as a glycated hemoglobin A1c level below 7.0 percent. The outcome will be calculated as the number of participants meeting the prespecified target divided by the number of participants with an available glycated hemoglobin A1c measurement at the corresponding visit.
Time frame
At 3, 6, and 12 months after randomization3
Percentage of Participants Achieving the Prespecified Low-Density Lipoprotein Cholesterol Target
Lipid control is defined as a low-density lipoprotein cholesterol level below 1.8 mmol/L or achievement of the individualized target specified in the protocol. If individualized targets are used, the target-assignment algorithm will be prespecified before enrollment. The outcome will be reported as the percentage of participants achieving their assigned target.
Time frame
At 3, 6, and 12 months after randomization4
Number of Participants Who Die From Any Cause
All-cause mortality is defined as death from any cause occurring after randomization. Deaths will be verified using hospital records, death certificates, or other available source documents and reviewed by an independent endpoint adjudication committee blinded to treatment allocation.
Time frame
From randomization through 12 monthsSponsors and contacts
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Source ClinicalTrials.gov
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