Smartphone Multimodal Health Intervention for Neurological Enhancement (SHINE)

July 22, 2025 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1036

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Zhejiang
      • HangZhou, Zhejiang, China, 310009
        • Second Affilated Hospital of Zhejiang University, School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Global cognitive function change assessed with Z-score of a digital cognitive assessment protocol
Time Frame: 6 months
Primary Outcome
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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)
Time Frame: 6 months, 1 year, 2 years
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)
Time Frame: 6 months, 1 year, 2 years
Secondary Outcome
6 months, 1 year, 2 years
Metabolite composition to measure the metabolite profiles in participants' faecal samples and serum samples
Time Frame: 6 months, 1 year, 2 years
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)
Time Frame: 6 months, 1 year, 2 years
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)
Time Frame: 6 months, 1 year, 2 years
Secondary Outcome
6 months, 1 year, 2 years
Dementia and cerebrovascular events incidence
Time Frame: 2 years, 5 years
Secondary Outcome
2 years, 5 years
Gut microbiota determined by measuring specific bacterial levels in the fecal samples
Time Frame: 6 months, 1 year, 2 years
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)
Time Frame: 6 months, 1 year, 2 years
Secondary Outcome
6 months, 1 year, 2 years
Completeness of data uploads on digital platform
Time Frame: 6 months, 1 year, 2 years
Secondary Outcome
6 months, 1 year, 2 years
Change in waist circumference if overweight/obese
Time Frame: 6 months, 1 year, 2 years
Secondary Outcome
6 months, 1 year, 2 years
Change in body mass index (BMI) if overweight/obese
Time Frame: 6 months, 1 year, 2 years
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)
Time Frame: 6 months, 1 year, 2 years
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)
Time Frame: 6 months, 1 year, 2 years
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)
Time Frame: 6 months, 1 year, 2 years
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)
Time Frame: 6 months, 1 year, 2 years
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)
Time Frame: 6 months, 1 year, 2 years
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)
Time Frame: 6 months, 1 year, 2 years
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)
Time Frame: 6 months, 1 year, 2 years
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)
Time Frame: 6 months, 1 year, 2 years
Secondary Outcome
6 months, 1 year, 2 years
Change in level of physical activity assessed with daily step count
Time Frame: 6 months, 1 year, 2 years
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
Time Frame: 6 months, 1 year, 2 years
Secondary Outcome
6 months, 1 year, 2 years
Change in systolic blood pressure (SBP) in participants with self-report history of hypertension
Time Frame: 6 months, 1 year, 2 years
Secondary Outcome
6 months, 1 year, 2 years
Change in diastolic blood pressure (DBP) in participants with self-report history of hypertension
Time Frame: 6 months, 1 year, 2 years
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
Time Frame: 6 months, 1 year, 2 years
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)
Time Frame: 6 months, 1 year, 2 years
Secondary Outcome
6 months, 1 year, 2 years
Change in glycated hemoglobin (HbA1c) levels (%) in participants with self-report history of diabetes
Time Frame: 6 months, 1 year, 2 years
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
Time Frame: 6 months, 1 year, 2 years
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
Time Frame: 6 months, 1 year, 2 years
Secondary Outcome
6 months, 1 year, 2 years
Change in total cholesterol (TC) levels in participants with self-report history of dyslipidemia
Time Frame: 6 months, 1 year, 2 years
Secondary Outcome
6 months, 1 year, 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Digital Multimodal Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings