Smartphone Multimodal Health Intervention for Neurological Enhancement (SHINE)

Smartphone Multimodal Health Intervention for Neurological Enhancement (SHINE) in High Stroke-risk Population: a Randomized Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke; Cognitive Impairment; Dementia; Cognitive Decline; Artificial Intelligence (AI)
• Intervention / Treatment: Behavioral: Digital Multimodal Intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 1036
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Min Lou, PhD, MD; Phone Number: 13958007213; Email: lm99@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • HangZhou, Zhejiang, China, 310009
      • Second Affilated Hospital of Zhejiang University, School of Medicine
      • Contact: Min Lou, PhD, MD; Phone Number: 13958007213; Email: lm99@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Digital Multimodal Intervention Group; 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	Behavioral: Digital 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
No Intervention: Standard health counseling; standard educational materials and care at baseline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global cognitive function change assessed with Z-score of a digital cognitive assessment protocol	Primary Outcome	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)	Secondary 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)	Secondary Outcome	6 months, 1 year, 2 years
Metabolite composition to measure the metabolite profiles in participants' faecal samples and serum samples	Secondary Outcome	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)	Secondary 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)	Secondary Outcome	6 months, 1 year, 2 years
Dementia and cerebrovascular events incidence	Secondary Outcome	2 years, 5 years
Gut microbiota determined by measuring specific bacterial levels in the fecal samples	Secondary 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)	Secondary Outcome	6 months, 1 year, 2 years
Completeness of data uploads on digital platform	Secondary Outcome	6 months, 1 year, 2 years
Change in waist circumference if overweight/obese	Secondary Outcome	6 months, 1 year, 2 years
Change in body mass index (BMI) if overweight/obese	Secondary Outcome	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)	Secondary Outcome	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)	Secondary 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)	Secondary 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)	Secondary Outcome	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)	Secondary 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)	Secondary Outcome	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)	Secondary 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)	Secondary Outcome	6 months, 1 year, 2 years
Change in level of physical activity assessed with daily step count	Secondary Outcome	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	Secondary Outcome	6 months, 1 year, 2 years
Change in systolic blood pressure (SBP) in participants with self-report history of hypertension	Secondary Outcome	6 months, 1 year, 2 years
Change in diastolic blood pressure (DBP) in participants with self-report history of hypertension	Secondary Outcome	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	Secondary Outcome	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)	Secondary Outcome	6 months, 1 year, 2 years
Change in glycated hemoglobin (HbA1c) levels (%) in participants with self-report history of diabetes	Secondary Outcome	6 months, 1 year, 2 years
Change in low-density lipoprotein cholesterol (LDL-C) levels in participants with self-report history of dyslipidemia	Secondary Outcome	6 months, 1 year, 2 years
Change in high-density lipoprotein cholesterol (HDL-C) levels in participants with self-report history of dyslipidemia	Secondary Outcome	6 months, 1 year, 2 years
Change in total cholesterol (TC) levels in participants with self-report history of dyslipidemia	Secondary Outcome	6 months, 1 year, 2 years

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: May 12, 2025
• First Submitted That Met QC Criteria: July 22, 2025
• First Posted (Actual): July 29, 2025

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: dementia; cognitive decline; cognitive impairment; stoke; Artificial intelligence (AI)
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Dementia
• Other Study ID Numbers: SHINE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No