Digital Health, Ischemic Stroke
Conditions
Keywords
ischemic stroke, digital health, risk factor
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.
Interventions
DEVICEDigital 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)
OTHERUsual Stroke Secondary Prevention Management
Participants in this arm receive standard care according to current clinical guidelines for stroke secondary prevention.
Sponsors
Affiliated Hospital of Nantong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving the Prespecified Blood Pressure Target | At 3, 6, and 12 months after randomization | 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. |
| Percentage of Participants Achieving the Prespecified Glycemic Target | At 3, 6, and 12 months after randomization | 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. |
| Percentage of Participants Achieving the Prespecified Low-Density Lipoprotein Cholesterol Target | At 3, 6, and 12 months after randomization | 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. |
| Number of Participants Who Die From Any Cause | From randomization through 12 months | 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. |
| Number of Participants Who Die From a Cardiovascular Cause | From randomization through 12 months | Cardiovascular death is defined as death attributable to stroke, myocardial infarction, heart failure, sudden cardiac death, or another vascular cause, according to prespecified endpoint definitions. All suspected cardiovascular deaths will be adjudicated by an independent blinded endpoint committee. |
| Number of Participants With Nonfatal Myocardial Infarction | From randomization through 12 months | Nonfatal myocardial infarction is defined according to the prespecified clinical, electrocardiographic, imaging, and cardiac biomarker criteria in the study protocol. Participants with at least one confirmed nonfatal myocardial infarction will be counted once. |
| Number of Participants Hospitalized for Heart Failure | From randomization through 12 months | Heart failure hospitalization is defined as an unplanned hospital admission primarily due to signs or symptoms of heart failure that requires initiation or intensification of heart failure treatment. Participants with at least one confirmed hospitalization will be counted once. |
| Change From Baseline in the Adherence to Refills and Medications Scale Total Score | Baseline and 3, 6, and 12 months after randomization | Medication adherence will be assessed using the 12-item Adherence to Refills and Medications Scale. Each item is scored from 1 to 4, producing a total score ranging from 12 to 48. Lower scores indicate better medication adherence. Change from baseline will be calculated as the follow-up score minus the baseline score. |
| Change From Baseline in the National Institutes of Health Stroke Scale Total Score | Baseline and 3, 6, and 12 months after randomization | Neurological impairment will be assessed using the National Institutes of Health Stroke Scale. Total scores range from 0 to 42, with higher scores indicating greater neurological impairment. Change from baseline will be calculated as the follow-up score minus the baseline score. |
| Modified Rankin Scale Score | At 3, 6, and 12 months after randomization | Global functional status will be assessed using the modified Rankin Scale. Scores range from 0 to 6, where 0 indicates no symptoms, 5 indicates severe disability, and 6 indicates death. Higher scores indicate worse functional outcomes. The distribution of scores will be compared between the study groups. |
| Percentage of Participants With Functional Independence | At 3, 6, and 12 months after randomization | Functional independence is defined as a modified Rankin Scale score of 0 to 2. The outcome will be reported as the percentage of participants meeting this definition at each follow-up visit. |
| Change From Baseline in the EQ-5D Index Score | Baseline and 3, 6, and 12 months after randomization | Health-related quality of life will be assessed using the prespecified version of the EQ-5D instrument. Health states will be converted to an index score using the prespecified Chinese population value set. Higher index scores indicate better health-related quality of life. Change from baseline will be calculated as the follow-up score minus the baseline score. |
| Change From Baseline in the EQ Visual Analogue Scale Score | Baseline and 3, 6, and 12 months after randomization | Participants will rate their overall health using the EQ Visual Analogue Scale, which ranges from 0 to 100. A score of 0 represents the worst imaginable health and a score of 100 represents the best imaginable health. Change from baseline will be calculated as the follow-up score minus the baseline score. |
| Change From Baseline in the Patient Health Questionnaire-9 Total Score | Baseline and 3, 6, and 12 months after randomization | Depressive symptoms will be assessed using the 9-item Patient Health Questionnaire. Total scores range from 0 to 27, with higher scores indicating greater severity of depressive symptoms. Change from baseline will be calculated as the follow-up score minus the baseline score. |
| Change From Baseline in the Generalized Anxiety Disorder-7 Total Score | Baseline and 3, 6, and 12 months after randomization | Anxiety symptoms will be assessed using the 7-item Generalized Anxiety Disorder scale. Total scores range from 0 to 21, with higher scores indicating greater severity of anxiety symptoms. Change from baseline will be calculated as the follow-up score minus the baseline score. |
| Percentage of Participants Who Currently Smoke | Baseline and 12 months after randomization | Current smoking will be determined using the prespecified lifestyle questionnaire. The definition of current smoking, including the type and frequency of tobacco use and the applicable reference period, will be specified before enrollment. |
| Mean Daily Step Count | During prespecified 7-day monitoring periods at baseline and 3, 6, and 12 months after randomization | Daily step count will be measured using the study wearable device. The mean daily step count will be calculated using data collected during a prespecified valid monitoring window. A valid day will require at least 10 hours of device wear, and participants must have at least 4 valid days during each assessment window. |
| Mean Daily Moderate-to-Vigorous Physical Activity Duration | During prespecified 7-day monitoring periods at baseline and 3, 6, and 12 months after randomization | Moderate-to-vigorous physical activity will be estimated using the study wearable device and the prespecified device algorithm. The mean number of minutes per valid monitoring day will be calculated during each assessment window. |
| Mean Daily Sedentary Time | During prespecified 7-day monitoring periods at baseline and 3, 6, and 12 months after randomization | Sedentary time will be estimated using the study wearable device and the prespecified device algorithm. The mean number of sedentary minutes per valid monitoring day will be calculated during each assessment window. |
| Mean Nightly Sleep Duration | During prespecified 7-night monitoring periods at baseline and 3, 6, and 12 months after randomization | Sleep duration will be estimated using the study wearable device and the prespecified sleep-detection algorithm. Mean nightly sleep duration will be calculated using nights with valid device recordings during each assessment window. |
Countries
China
Contacts
CONTACTQiuhong Ji
CONTACTLei Li
STUDY_CHAIRQiuhong Ji
Affiliated Hospital of Nantong University
Outcome results
None listed