Prevention of Ischemic Stroke Recurrence Using Digital Technology Application

NCT07825311 | Not Yet Recruiting

• 1 other identifier: 2026-K241-01
• Study Type: interventional
• Target: 1,696
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ischemic Stroke; Digital Health

Keywords

ischemic stroke; digital health; risk factor

Outcome Measures

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.

  From randomization through 12 months

Secondary Outcomes (20)

• Percentage of Participants Achieving the Prespecified Blood Pressure Target

  At 3, 6, and 12 months after randomization

• Percentage of Participants Achieving the Prespecified Glycemic Target

  At 3, 6, and 12 months after randomization

• Percentage of Participants Achieving the Prespecified Low-Density Lipoprotein Cholesterol Target

  At 3, 6, and 12 months after randomization

• Number of Participants Who Die From Any Cause

  From randomization through 12 months

• Number of Participants Who Die From a Cardiovascular Cause

  From randomization through 12 months

Study Arms (2)

Digital Prevention Management

EXPERIMENTAL

This arm receives the wearable device + digital platform intervention, which is the focus of the study and is being tested for efficacy.

Device: Digital Prevention Management

Usual Stroke Secondary Prevention

ACTIVE COMPARATOR

This arm receives usual stroke secondary prevention management, which is the current standard of care and is considered effective in treating/ preventing the condition under study.

Other: Usual Stroke Secondary Prevention Management

Interventions

Digital Prevention Management DEVICE

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)

Digital Prevention Management

Usual Stroke Secondary Prevention Management OTHER

Participants in this arm receive standard care according to current clinical guidelines for stroke secondary prevention.

Usual Stroke Secondary Prevention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226000, China

Location

Related Publications (1)

• GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021 Oct;20(10):795-820. doi: 10.1016/S1474-4422(21)00252-0. Epub 2021 Sep 3.

  PMID: 34487721 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Qiuhong Ji

  Affiliated Hospital of Nantong University

  STUDY CHAIR

Central Study Contacts

Qiuhong Ji

CONTACT

+8613962916293; jiqiuhong@ntu.edu.cn

Lei Li

CONTACT

+8613815434184; lilei.nj@live.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2026
• First Posted: September 17, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): June 30, 2029
• Last Updated: September 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)