NCT07092371尚未招募不适用
Smartphone Multimodal Health Intervention for Neurological Enhancement (SHINE) in High Stroke-risk Population: a Randomized Trial
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 1,036 人开始时间: 2025年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,036
- 试验地点
- 1
- 主要终点
- Global cognitive function change assessed with Z-score of a digital cognitive assessment protocol
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Global cognitive function change assessed with Z-score of a digital cognitive assessment protocol
时间窗: 6 months
Primary Outcome
次要结局
- 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)
- 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)
- Completeness of data uploads on digital platform(6 months, 1 year, 2 years)
- Change in waist circumference if overweight/obese(6 months, 1 year, 2 years)
- 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)
- 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)
- 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)
- 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)
- 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)
- Change in glycated hemoglobin (HbA1c) levels (%) in participants with self-report history of diabetes(6 months, 1 year, 2 years)
- Metabolite composition to measure the metabolite profiles in participants' faecal samples and serum samples(6 months, 1 year, 2 years)
- 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)
- Change in level of physical activity assessed with daily step count(6 months, 1 year, 2 years)
- 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)
- 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)
- language domain cognitive score change assessed with a digital cognitive assessment protocol (higher scores mean a better outcome)(6 months, 1 year, 2 years)
- 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)
- 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)
- 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)
- 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)
- Change in systolic blood pressure (SBP) in participants with self-report history of hypertension(6 months, 1 year, 2 years)
- Dementia and cerebrovascular events incidence(2 years, 5 years)
- Gut microbiota determined by measuring specific bacterial levels in the fecal samples(6 months, 1 year, 2 years)
- Change in body mass index (BMI) if overweight/obese(6 months, 1 year, 2 years)
- 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)
- Change in diastolic blood pressure (DBP) in participants with self-report history of hypertension(6 months, 1 year, 2 years)
- Change in low-density lipoprotein cholesterol (LDL-C) levels in participants with self-report history of dyslipidemia(6 months, 1 year, 2 years)
- Change in high-density lipoprotein cholesterol (HDL-C) levels in participants with self-report history of dyslipidemia(6 months, 1 year, 2 years)
- Change in total cholesterol (TC) levels in participants with self-report history of dyslipidemia(6 months, 1 year, 2 years)
研究者
研究点 (1)
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