Tailored Brain Health Insights Through Nurturing Knowledge-based Change - Stakeholder-driven, Human-centered, AI-powered Refinement for Prevention (THINK-SHARP)
21 мая 2026 г. обновлено: Alexandra Hospital
Tailored Brain Health Insights Through Nurturing Knowledge-based Change - Stakeholder-driven, Human-centered, AI-powered Refinement for Prevention (THINK-SHARP)
The goal of this clinical trial is to evaluate whether an AI-powered digital brain health coaching intervention can improve modifiable brain health risk factors in community-dwelling adults aged 40 and above in Singapore.
The main question it aims to answer is: does the use of BLAZE, an AI-powered digital brain health coaching intervention, lead to a greater improvement in Brain Care Score (BCS) compared to usual care at 6 months?
Researchers will compare participants receiving BLAZE to those receiving usual care (waitlist control) to see if BLAZE leads to greater improvements in brain health risk factors, behavioural outcomes, quality of life, and cost-effectiveness.
Participants will:
- Be randomly assigned to either receive BLAZE immediately for 12 months or be placed on a waitlist receiving usual care for the first 6 months before receiving BLAZE for a further 6 months
- Complete a series of assessments at baseline, 6 months, and 12 months including the Brain Care Score, physical function tests, cognitive assessments, quality of life measures, and lifestyle behaviour questionnaires
- If assigned to the intervention group, interact with BLAZE via a WhatsApp-based platform that delivers personalised brain health recommendations, behavioural nudges, educational content, and goal-setting support based on their individual Brain Care Score profile
Обзор исследования
Статус
Еще не набирают
Вмешательство/лечение
Подробное описание
Dementia represents a growing public health challenge in Singapore and across the Asia-Pacific region, with prevalence projected to rise substantially as the population ages. Up to 40% of dementia risk is attributable to modifiable lifestyle factors, highlighting significant potential for prevention through targeted behavioural interventions. Despite this, translating evidence-based lifestyle recommendations into sustained behavioural change in community settings remains a significant challenge, particularly given the limited time available for personalised guidance in primary care.
The THINK-SHARP trial evaluates BLAZE (Brain health Lifestyle Action with personaliZed Engagement), a theory-driven AI-powered digital coaching intervention designed to support brain health behaviours in community-dwelling adults. BLAZE is grounded in the Capability-Opportunity-Motivation-Behaviour (COM-B) framework, a well-established behavioural science model, and is delivered via a WhatsApp-based platform integrated with a large language model (LLM). The intervention operates through four integrated modules - Assessment, Education, Nudge, and Coaching - to deliver personalised recommendations, behavioural prompts, and goal-setting support tailored to each participant's individual brain health profile.
Personalisation is driven by the Brain Care Score (BCS), a validated composite measure of modifiable physical, lifestyle, and social-emotional risk factors for brain health. BLAZE uses each participant's BCS profile to identify priority areas for behavioural change and generates adaptive, data-driven recommendations accordingly. All content is informed by a curated knowledge base developed in collaboration with neurologists and geriatricians to ensure clinical relevance and safety.
The trial employs a two-arm, waitlist-controlled randomised controlled trial (RCT) design, with 350 participants randomised 1:1 to either the immediate intervention arm or the waitlist control arm. The immediate intervention arm receives BLAZE for 12 months, while the waitlist control arm receives usual care for the first 6 months before crossing over to receive BLAZE for a further 6 months. The primary outcome is the between-group difference in BCS at 6 months. Secondary outcomes assess changes across six domains: physical function, lifestyle behaviours, self-management and health engagement, cognitive function, quality of life, and social health.
Beyond clinical effectiveness, the trial incorporates a concurrent process evaluation to assess implementation outcomes including adherence, feasibility, usability, and perceived value of the intervention. A model-based health economic evaluation will also be conducted to estimate the long-term cost-effectiveness of BLAZE from the Singapore public healthcare payer perspective. Together, these components provide a comprehensive assessment of BLAZE's potential as a scalable, behaviourally grounded approach to community brain health promotion.
This trial also contributes novel evidence on the applicability of the Brain Care Score within a Southeast Asian community-dwelling population, extending its validation beyond previously studied settings and supporting its relevance for regional brain health promotion efforts.
Тип исследования
Интервенционный
Регистрация (Оцененный)
350
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Dr Li Feng Tan
- Номер телефона: +65 (65)85018320
- Электронная почта: ah_brainhealth@nuhs.edu.sg
Места учебы
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Singapore
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Singapore, Singapore, Сингапур
- Alexandra Hospital
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Контакт:
- Dr Li Feng Tan
- Номер телефона: +65 (65)85018320
- Электронная почта: ah_brainhealth@nuhs.edu.sg
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Да
Описание
Inclusion Criteria:
- Community-dwelling adults
- Aged 40 years and above at time of recruitment
- Able to use a smartphone and smartphone applications
- Able to provide written informed consent
Exclusion Criteria:
- Been diagnosed wotj dementia, neurocognitive disorder or any major psychiatric illness
- Have severe sensory or physical disability precluding usage of the application
- Terminal illness or expected survival of less than 12 months at point of recruitment
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Исследования в области здравоохранения
- Распределение: Рандомизированный
- Интервенционная модель: Последовательное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Другой: Waitlist Control
Participants assigned to the waitlist control arm will receive usual care for the first 6 months of the study, consisting of standard educational materials on brain health.
Following the 6-month assessment, waitlist control participants will receive full access to BLAZE for a further 6 months (months 6-12), identical to the intervention described in the immediate intervention arm.
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BLAZE is an AI-powered digital brain health coaching intervention delivered via a WhatsApp-based platform integrated with a large language model (LLM).
Grounded in the COM-B behavioural framework, BLAZE operates through four integrated modules - Assessment, Education, Nudge, and Coaching - to deliver personalised recommendations, behavioural nudges, educational content, and goal-setting support.
Personalisation is driven by each participant's Brain Care Score (BCS) profile, with intervention intensity stratified according to domain-specific scores.
All content is informed by a curated knowledge base developed in collaboration with neurologists and geriatricians
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Активный компаратор: BLAZE Intervention
Participants assigned to the immediate intervention arm will receive access to BLAZE (Brain health Lifestyle Action with personaliZed Engagement) for 12 months.
|
BLAZE is an AI-powered digital brain health coaching intervention delivered via a WhatsApp-based platform integrated with a large language model (LLM).
Grounded in the COM-B behavioural framework, BLAZE operates through four integrated modules - Assessment, Education, Nudge, and Coaching - to deliver personalised recommendations, behavioural nudges, educational content, and goal-setting support.
Personalisation is driven by each participant's Brain Care Score (BCS) profile, with intervention intensity stratified according to domain-specific scores.
All content is informed by a curated knowledge base developed in collaboration with neurologists and geriatricians
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Brain Care Score
Временное ограничение: 12 months
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To evaluate whether the AI-powered Brain Health Coach, BLAZE, improves BCS in community-dwelling adults versus usual care.
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12 months
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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NHG Healthy Eating Score
Временное ограничение: 12 months
|
A self-reported questionnaire assessing dietary habits aligned with brain health recommendations.
Scores range from 0 to 100, with higher scores indicating healthier dietary behaviours.
Improvement in score reflects adoption of healthier eating patterns across domains targeted by the intervention.
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12 months
|
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EuroQol-5 (EQ-5D)
Временное ограничение: 12 months
|
A standardised measure of health-related quality of life assessing five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Each dimension is rated on a scale of 1 (no problems) to 5 (extreme problems/unable to perform), generating a health utility index score where higher values indicate better health-related quality of life.
Participants also rate their overall health on a Visual Analogue Scale (VAS) from 0 (worst imaginable health) to 100 (best imaginable health).
|
12 months
|
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Lawton Instrumental Activities of Daily Living (IADL)
Временное ограничение: 12 months
|
A self-reported measure assessing the ability to perform complex daily tasks such as managing finances, using transportation, preparing meals, and using the telephone.
Scores range from 0 to 8, with higher scores indicating greater functional independence.
This measure monitors maintenance of functional independence in community-dwelling adults over the course of the study.
|
12 months
|
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Katz Index of Independence in Activities of Daily Living (ADL)
Временное ограничение: 12 months
|
A measure assessing independence in six basic daily activities: bathing, dressing, toileting, transferring, continence, and feeding.
Each activity is scored as independent (1) or dependent (0), yielding a total score of 0 to 6, where higher scores indicate greater independence.
This measure monitors for any unexpected decline in basic functional independence during the study period.
|
12 months
|
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UCLA Loneliness Scale (UCLA-3)
Временное ограничение: 12 months
|
A 3-item self-reported measure assessing subjective feelings of loneliness and social isolation.
Each item is rated on a scale of 1 (hardly ever) to 3 (often), with total scores ranging from 3 to 9. Higher scores indicate greater loneliness.
A reduction in score reflects improved social connectedness targeted through the intervention's social engagement recommendations.
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12 months
|
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Health Status (Self-Rated Health)
Временное ограничение: 12 months
|
A single-item measure asking participants to rate their overall health on a scale of 1 (excellent) to 5 (poor), or alternatively using a 5-point scale from poor to excellent depending on the version used.
Higher scores on the favourable end of the scale indicate better perceived health status.
This measure captures overall perceived wellbeing as a downstream indicator of sustained lifestyle behaviour change.
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12 months
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Lubben Social Network Scale (LSNS-6)
Временное ограничение: 12 months
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A 6-item self-reported measure assessing the size and frequency of a participant's social network, including family and friend contacts.
Scores range from 0 to 30, with higher scores indicating stronger social networks.
A score below 12 is considered indicative of social isolation risk.
Improvement in score reflects strengthened social connections targeted through the intervention's social health domain recommendations.
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12 months
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Chair Stand Test
Временное ограничение: 12 months
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An objective performance-based measure of lower body strength and physical function.
Participants are timed completing five sit-to-stand repetitions from a chair without using their arms.
Faster completion times indicate better lower body strength and physical function.
Improvement in performance reflects increased physical activity and strength targeted through the intervention's physical health recommendations.
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12 months
|
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Grip Strength
Временное ограничение: 12 months
|
An objective measure of overall muscular strength assessed using a handheld dynamometer.
Results are recorded in kilograms, with higher values indicating greater muscular strength.
Improvement in grip strength reflects sustained engagement in physical activity behaviours targeted through the intervention.
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12 months
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Adapted Dementia Knowledge and Attitudes (14-item)
Временное ограничение: 12 months
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A 14-item adapted questionnaire assessing knowledge of dementia risk factors, symptoms, and prevention strategies, as well as attitudes towards dementia.
Six items were adapted from the validated Dementia Knowledge and Attitudes Scale (DKAS) and ten items from a comparative analysis of dementia health literacy in Singapore.
Higher scores indicate greater dementia knowledge and more positive attitudes towards dementia.
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12 months
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Partners in Health Scale (PIH)
Временное ограничение: 12 months
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A 12-item self-reported measure assessing self-management capacity across four domains: knowledge of condition, adherence to treatment, recognition and management of symptoms, and coping.
Each item is rated on a scale of 0 to 8, with total scores ranging from 0 to 96.
Higher scores indicate greater self-management capacity.
Improvement in score reflects the intervention's coaching module supporting independent brain health management.
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12 months
|
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Rapid Assessment of Physical Activity (RAPA)
Временное ограничение: 12 months
|
A self-reported questionnaire assessing aerobic physical activity levels and strength and flexibility behaviours.
The aerobic component is scored from 1 to 7, where scores of 1-4 indicate sub-optimal activity levels and scores of 5-7 indicate recommended levels of moderate to vigorous physical activity.
The strength and flexibility component is scored from 0 to 2. Higher scores across both components indicate more active lifestyle behaviours.
Improvement reflects the intervention's physical activity nudges and goal-setting support.
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12 months
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Montreal Cognitive Assessment (MoCA)
Временное ограничение: 12 months
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A brief 30-item cognitive screening tool assessing multiple cognitive domains including memory, attention, language, visuospatial ability, and orientation.
Scores range from 0 to 30, with higher scores indicating better cognitive function.
A score of 26 or above is considered within the normal range.
This measure provides a baseline cognitive profile and enables monitoring of any meaningful change in global cognitive function during the study period.
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12 months
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Публикации и полезные ссылки
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Полезные ссылки
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
1 сентября 2026 г.
Первичное завершение (Оцененный)
31 декабря 2029 г.
Завершение исследования (Оцененный)
31 декабря 2029 г.
Даты регистрации исследования
Первый отправленный
21 мая 2026 г.
Впервые представлено, что соответствует критериям контроля качества
21 мая 2026 г.
Первый опубликованный (Действительный)
29 мая 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
29 мая 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
21 мая 2026 г.
Последняя проверка
1 мая 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2025-1562
- NICCOG2024-0027 (Другой номер гранта/финансирования: Singapore National Medical Research Council)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕ РЕШЕНО
Описание плана IPD
A decision on whether and how individual participant data will be shared with external researchers has not yet been made.
Plans for data sharing will be determined following completion of the trial and will be guided by applicable institutional policies, ethical considerations, and data governance requirements in Singapore.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .