Cognitive ImpairmentNCT07092371
Smartphone Multimodal Health Intervention for Neurological Enhancement (SHINE)
A study testing Digital Multimodal Intervention in people with Cognitive Impairment and Dementia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cognitive Impairment, Dementia, Artificial Intelligence (AI)
- What is being tested?
- Digital Multimodal Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,036 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2025to 1 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Second Affilated Hospital of Zhejiang University, School of Medicine
Hangzhou, Zhejiang, 310009
Min Lou, PhD, MD, 13958007213, lm99@zju.edu.cn
About this study
Official title: 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.
Read the 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.
- Being tested
- Digital Multimodal Intervention
- Keywords
- stoke, cognitive impairment, cognitive decline, dementia, Artificial intelligence (AI)
- Medical subject headings
- Cognitive Dysfunction, Dementia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Multimodal InterventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Digital Multimodal Intervention Group | Active comparator | 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 Receives: Behavioral: Digital Multimodal Intervention |
| Standard health counseling | No intervention | standard educational materials and care at baseline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global cognitive function change assessed with Z-score of a digital cognitive assessment protocol
Primary Outcome
Measured: 6 months
Secondary outcomes (29)
Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
Secondary Outcome
Measured: 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
Measured: 6 months, 1 year, 2 years
Metabolite composition to measure the metabolite profiles in participants' faecal samples and serum samples
Secondary Outcome
Measured: 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
Measured: 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
Measured: 6 months, 1 year, 2 years
Dementia and cerebrovascular events incidence
Secondary Outcome
Measured: 2 years, 5 years
Gut microbiota determined by measuring specific bacterial levels in the fecal samples
Secondary Outcome
Measured: 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
Measured: 6 months, 1 year, 2 years
Completeness of data uploads on digital platform
Secondary Outcome
Measured: 6 months, 1 year, 2 years
Change in waist circumference if overweight/obese
Secondary Outcome
Measured: 6 months, 1 year, 2 years
Change in body mass index (BMI) if overweight/obese
Secondary Outcome
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months, 1 year, 2 years
Change in level of physical activity assessed with daily step count
Secondary Outcome
Measured: 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
Measured: 6 months, 1 year, 2 years
Change in systolic blood pressure (SBP) in participants with self-report history of hypertension
Secondary Outcome
Measured: 6 months, 1 year, 2 years
Change in diastolic blood pressure (DBP) in participants with self-report history of hypertension
Secondary Outcome
Measured: 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
Measured: 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
Measured: 6 months, 1 year, 2 years
Change in glycated hemoglobin (HbA1c) levels (%) in participants with self-report history of diabetes
Secondary Outcome
Measured: 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
Measured: 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
Measured: 6 months, 1 year, 2 years
Change in total cholesterol (TC) levels in participants with self-report history of dyslipidemia
Secondary Outcome
Measured: 6 months, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,036 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07092371
- Sponsor's protocol ID
- SHINE
- Status last verified
- May 2025
- First submitted
- 12 May 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone Multimodal Health Intervention for Neurological Enhancement (SHINE) in High Stroke-risk Population: a Randomized Trial
- ClinicalTrials.gov ID
- NCT07092371
- Acronym / sponsor ID
- SHINE
- Keywords
- stoke, cognitive impairment, cognitive decline, dementia, Artificial intelligence (AI)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,036 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Multimodal Intervention Group | Active comparator | Behavioral: Digital Multimodal InterventionParticipants 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 |
| Standard health counseling | No intervention | –standard educational materials and care at baseline |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Multimodal InterventionParticipants 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 | Behavioural | Digital Multimodal Intervention Group |
Primary outcome
Global cognitive function change assessed with Z-score of a digital cognitive assessment protocol
Time frame: 6 months
Primary Outcome
29 secondary outcomes
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
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
Metabolite composition to measure the metabolite profiles in participants' faecal samples and serum samples
Time frame: 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
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
Dementia and cerebrovascular events incidence
Time frame: 2 years, 5 years
Gut microbiota determined by measuring specific bacterial levels in the fecal samples
Time frame: 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
Completeness of data uploads on digital platform
Time frame: 6 months, 1 year, 2 years
Change in waist circumference if overweight/obese
Time frame: 6 months, 1 year, 2 years
Change in body mass index (BMI) if overweight/obese
Time frame: 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
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
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
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
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
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
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
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
Change in level of physical activity assessed with daily step count
Time frame: 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
Change in systolic blood pressure (SBP) in participants with self-report history of hypertension
Time frame: 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
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
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
Change in glycated hemoglobin (HbA1c) levels (%) in participants with self-report history of diabetes
Time frame: 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
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
Change in total cholesterol (TC) levels in participants with self-report history of dyslipidemia
Time frame: 6 months, 1 year, 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Multimodal Intervention in people with Cognitive Impairment and Dementia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min Lou, PhD, MD (13958007213, lm99@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global cognitive function change assessed with Z-score of a digital cognitive assessment protocol (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.