Artificial Intelligence (AI), Cognitive Decline, Cognitive Impairment, Dementia, Stroke
Conditions
Keywords
stoke, cognitive impairment, cognitive decline, dementia, Artificial intelligence (AI)
Brief summary
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.
Detailed description
The Smartphone-based multimodal Health Intervention for Neurological Enhancement (SHINE) trial is designed to test the impact of a 6-month artificial intelligence(AI)-assisted intervention utilizing smartphone-based multimodal lifestyle and stroke risk factor management on 1036 participants aged 40 years and above who are without dementia and are at high risk for stroke. The multimodal digital program integrated adaptive cognitive training, personalized cardiovascular risk management, smart wristband-based physical activity and sleep monitoring, and dietary guidance, all delivered through a smartphone application incorporating behavioral change and AI techniques. Participants in the intervention group will receive the lifestyle and stroke risk factors management, while participants in the control group will receive standard educational materials and care. The investigation will explore potential mediators and modifiers of the intervention's effects by collecting various cardiovascular risk factors, serum samples, fecal samples, neuropsychological assessment results, and multi-modal magnetic resonance imaging at baseline, 6 months, 1 year, and 2 years.
Interventions
BEHAVIORALDigital Multimodal Intervention
Participants will undergo a 6-month multimodal intervention via a digital platform, which includes: (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
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* previously diagnosed dementia * Suspected dementia after clinical assessment by study physician at screening visit * Previous history of major head trauma and any intracranial surgery * Intracranial abnormalities, such as intracerebral hemorrhage, subarachnoid hemorrhage and other space occupying lesions * Extrapyramidal symptoms or mental illness which may affect neuropsychological measurement * Severe loss of vision, hearing, or communicative ability * Patients presenting a malignant disease with life expectancy \< 3 years * Participation in an ongoing investigational drug study Exit Criteria: * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global cognitive function change assessed with Z-score of a digital cognitive assessment protocol | 6 months | Primary Outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive function change assessed with Mini-Mental State Examination (minimum value = 0, maximum value = 30, and higher scores mean a better outcome) | 6 months, 1 year, 2 years | Secondary Outcome |
| Metabolite composition to measure the metabolite profiles in participants' faecal samples and serum samples | 6 months, 1 year, 2 years | Secondary Outcome |
| The Oriental Intervention for Enhanced Neurocognitive health (ORIENT) diet score (minimum value = 0, maximum value = 14, and higher scores mean a better outcome) | 6 months, 1 year, 2 years | Secondary Outcome |
| Sleep quality assessed by Pittsburgh sleep quality index (minimum value = 0, maximum value = 21, and higher scores mean a worse outcome) | 6 months, 1 year, 2 years | Secondary Outcome |
| Dementia and cerebrovascular events incidence | 2 years, 5 years | Secondary Outcome |
| Gut microbiota determined by measuring specific bacterial levels in the fecal samples | 6 months, 1 year, 2 years | Secondary Outcome |
| Frequency of digital platform usage for lifestyle and risk factor management (number of weekly platform feature accesses, tracked through platform analytics) | 6 months, 1 year, 2 years | Secondary Outcome |
| Completeness of data uploads on digital platform | 6 months, 1 year, 2 years | Secondary Outcome |
| Change in waist circumference if overweight/obese | 6 months, 1 year, 2 years | Secondary Outcome |
| Change in body mass index (BMI) if overweight/obese | 6 months, 1 year, 2 years | Secondary Outcome |
| working memory domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome) | 6 months, 1 year, 2 years | Secondary Outcome |
| executive function domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome) | 6 months, 1 year, 2 years | Secondary Outcome |
| language domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome) | 6 months, 1 year, 2 years | Secondary Outcome |
| visual motor speed domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome) | 6 months, 1 year, 2 years | Secondary Outcome |
| Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better outcome) | 6 months, 1 year, 2 years | Secondary Outcome |
| memory and recognition domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome) | 6 months, 1 year, 2 years | Secondary Outcome |
| Visual Analogue Scale (VAS) score of EuroQol Five Dimension Five Level (EQ-5D-5L) Questionnaire (higher VAS score indicates better health status) | 6 months, 1 year, 2 years | Secondary Outcome |
| Utility index of EuroQol Five Dimension Five Level (EQ-5D-5L) Questionnaire (higher utility index indicates better health-related quality of life) | 6 months, 1 year, 2 years | Secondary Outcome |
| Change in level of physical activity assessed with daily step count | 6 months, 1 year, 2 years | Secondary Outcome |
| Change in level of physical activity assessed with Metabolic Equivalent of Task [MET] per week, higher MET per week means higher physical activity levels | 6 months, 1 year, 2 years | Secondary Outcome |
| Change in systolic blood pressure (SBP) in participants with self-report history of hypertension | 6 months, 1 year, 2 years | Secondary Outcome |
| Change in diastolic blood pressure (DBP) in participants with self-report history of hypertension | 6 months, 1 year, 2 years | Secondary Outcome |
| Change in fasting blood glucose levels in participants with self-report history of hypertension in participants with self-report history of diabetes | 6 months, 1 year, 2 years | Secondary Outcome |
| Change in insulin resistance assessed by Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) in participants with self-report history of diabetes (higher HOMA-IR indicatehigher insulin resistance) | 6 months, 1 year, 2 years | Secondary Outcome |
| Change in glycated hemoglobin (HbA1c) levels (%) in participants with self-report history of diabetes | 6 months, 1 year, 2 years | Secondary Outcome |
| Change in low-density lipoprotein cholesterol (LDL-C) levels in participants with self-report history of dyslipidemia | 6 months, 1 year, 2 years | Secondary Outcome |
| Change in high-density lipoprotein cholesterol (HDL-C) levels in participants with self-report history of dyslipidemia | 6 months, 1 year, 2 years | Secondary Outcome |
| Change in total cholesterol (TC) levels in participants with self-report history of dyslipidemia | 6 months, 1 year, 2 years | Secondary Outcome |
| visual spatial function domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome) | 6 months, 1 year, 2 years | Secondary Outcome |
Countries
China
Contacts
Primary ContactMin Lou, PhD, MD
Outcome results
None listed