Smartphone Multimodal Health Intervention for Neurological Enhancement (SHINE)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Digital Multimodal Intervention.
- Кому может быть актуально
- Состояния в реестре: Cognitive Impairment, Dementia, Artificial Intelligence (AI), Stroke. Базовые параметры: от 40 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Smartphone Multimodal Health Intervention for Neurological Enhancement (SHINE) in High Stroke-risk Population: a Randomized Trial
Обзор
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.
Подробное описание
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.
Вмешательства
- Поведенческое 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
Первичные конечные точки
- Global cognitive function change assessed with Z-score of a digital cognitive assessment protocol [Срок оценки: 6 months]
Вторичные конечные точки (12)
- Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better outcome) [Срок оценки: 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) [Срок оценки: 6 months, 1 year, 2 years]
- Metabolite composition to measure the metabolite profiles in participants' faecal samples and serum samples [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 6 months, 1 year, 2 years]
- Dementia and cerebrovascular events incidence [Срок оценки: 2 years, 5 years]
- Gut microbiota determined by measuring specific bacterial levels in the fecal samples [Срок оценки: 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) [Срок оценки: 6 months, 1 year, 2 years]
- Completeness of data uploads on digital platform [Срок оценки: 6 months, 1 year, 2 years]
- Change in waist circumference if overweight/obese [Срок оценки: 6 months, 1 year, 2 years]
- Change in body mass index (BMI) if overweight/obese [Срок оценки: 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) [Срок оценки: 6 months, 1 year, 2 years]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Профилактика
Центры проведения
Китай · 1 центр
- Second Affilated Hospital of Zhejiang University, School of Medicine — Ханчжоу
Идентификаторы
NCT: NCT07092371 · SHINE