Smartphone program to test brain health in people at high stroke risk
Tests a smartphone health program in adults aged 40 or older at high stroke risk.
Key facts
- Who runs it
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Where
- Hangzhou, ChinaSee the site
- Trial code
- Registry title
- Smartphone Multimodal Health Intervention for Neurological Enhancement (SHINE)
- Status
- Not yet recruiting
- People taking part
- 1,036 people, planned
- Started
- 1 Aug 2025
- Expected to end
- 1 Jul 2029
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Digital Multimodal Intervention
- Record updated
- 29 July 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 40 or older who have no dementia but a high risk of stroke. It tests a smartphone-based health program and its effect on thinking skills.
- Age
- 40 years or older
- Sex
- All sexes
- Disease stage
- High risk of stroke: at least 3 of 8 risk factors (high blood pressure, high blood fats, diabetes, atrial fibrillation or valve heart disease, smoking history, obvious overweight or obesity, lack of exercise, family history of stroke) or a transient ischemic attack. No dementia.
- Earlier treatment
- Not stated. People in another ongoing investigational drug study cannot join.
Main reasons for not taking part
- Previously diagnosed or suspected dementia
- Major head injury or brain surgery in the past
- Bleeding in the brain or other space-occupying lesions in the brain
- Movement disorder symptoms or mental illness that could affect thinking tests
- Cancer with life expectancy under 3 years
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- Patients aged ≥ 40 years
- High risk of stroke (with ≥ 3 of 8 stroke risk factors, including hypertension, dyslipidemia, diabetes, atrial fibrillation or valvular heart disease, smoking history, obvious overweight or obesity, lack of exercise, family history of stroke, or with transient ischemic attack)
- Written informed consent available
- Primary school education or above
- Proficient in using smartphones
- Willingness to complete all assessments and participate in follow-up
Who cannot take part
- previously diagnosed dementia
- Previous history of major head trauma and any intracranial surgery
- Participation in an ongoing investigational drug study; Exit Criteria:
- Suspected dementia after clinical assessment by study physician at screening visit
- Intracranial abnormalities, such as intracerebral hemorrhage, subarachnoid hemorrhage and other space occupying lesions
- Extrapyramidal symptoms or mental illness which may affect neuropsychological measurement
- Patients presenting a malignant disease with life expectancy < 3 years
- Severe loss of vision, hearing, or communicative ability
- Not meet the inclusion criteria
- For any poor adherence, not comply with the requirements of the follow-up, or safety reasons determined by investigator
- Any adverse or serious adverse events during the study period judged by Investigator
Where in China
- Second Affilated Hospital of Zhejiang University, School of MedicineHangzhou, ChinaContact: Min Lou, PhD, MDNo longer taking part
About the trial
What the trial wants to find out
This randomized controlled trial will enroll individuals aged ≥ 40 years without dementia who are at high risk for stroke, collecting multi-modal MRI imaging, serum, and fecal samples to investigate the effects of a smartphone-based multimodal health intervention on cognitive function measured using digital-evaluated cognitive scores.
The 2 groups in the trial
- Digital Multimodal Intervention GroupExisting treatment, for comparison
Participants will receive a 6-month multimodal intervention through a digital platform, including: (1) Personalized cognitive training; (2) Self-monitoring and management of stroke risk factors including hypertension, dyslipidemia, diabetes, smoking and obesity; (3) Smart wristband-based exercise monitoring and management; (4) Smart wristband-based sleep monitoring and management; (5) Health dietary recording and guidance
Treatment: Digital Multimodal Intervention
- Standard health counselingNo study treatment, for comparison
standard educational materials and care at baseline
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Smartphone Multimodal Health Intervention for Neurological Enhancement (SHINE) in High Stroke-risk Population: a Randomized Trial
- Plain-language title
- Smartphone program to test brain health in people at high stroke riskGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 29 July 2025