Tailored Brain Health Insights Through Nurturing Knowledge-based Change - Stakeholder-driven, Human-centered, AI-powered Refinement for Prevention (THINK-SHARP)
21 de maio de 2026 atualizado por: 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
Visão geral do estudo
Status
Ainda não está recrutando
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Estimado)
350
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Dr Li Feng Tan
- Número de telefone: +65 (65)85018320
- E-mail: ah_brainhealth@nuhs.edu.sg
Locais de estudo
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Singapore
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Singapore, Singapore, Cingapura
- Alexandra Hospital
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Contato:
- Dr Li Feng Tan
- Número de telefone: +65 (65)85018320
- E-mail: ah_brainhealth@nuhs.edu.sg
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Outro: 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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Comparador Ativo: 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
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Brain Care Score
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
NHG Healthy Eating Score
Prazo: 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.
|
12 months
|
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EuroQol-5 (EQ-5D)
Prazo: 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).
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12 months
|
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Lawton Instrumental Activities of Daily Living (IADL)
Prazo: 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.
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12 months
|
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Katz Index of Independence in Activities of Daily Living (ADL)
Prazo: 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.
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12 months
|
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UCLA Loneliness Scale (UCLA-3)
Prazo: 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)
Prazo: 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)
Prazo: 12 months
|
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
Prazo: 12 months
|
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
Prazo: 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)
Prazo: 12 months
|
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)
Prazo: 12 months
|
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)
Prazo: 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)
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
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Links úteis
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de setembro de 2026
Conclusão Primária (Estimado)
31 de dezembro de 2029
Conclusão do estudo (Estimado)
31 de dezembro de 2029
Datas de inscrição no estudo
Enviado pela primeira vez
21 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
21 de maio de 2026
Primeira postagem (Real)
29 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
29 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
21 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2025-1562
- NICCOG2024-0027 (Número de outro subsídio/financiamento: Singapore National Medical Research Council)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
Descrição do plano 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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .