Tailored Brain Health Insights Through Nurturing Knowledge-based Change - Stakeholder-driven, Human-centered, AI-powered Refinement for Prevention

Официальное название

Tailored Brain Health Insights Through Nurturing Knowledge-based Change - Stakeholder-driven, Human-centered, AI-powered Refinement for Prevention (THINK-SHARP)

Обзор

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

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.

Вмешательства

• Поведенческое BLAZE (Brain health Lifestyle Action with personaliZed Engagement)
  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 int

Первичные конечные точки

• Brain Care Score [Срок оценки: 12 months]

Вторичные конечные точки (12)

• NHG Healthy Eating Score [Срок оценки: 12 months]
• EuroQol-5 (EQ-5D) [Срок оценки: 12 months]
• Lawton Instrumental Activities of Daily Living (IADL) [Срок оценки: 12 months]
• Katz Index of Independence in Activities of Daily Living (ADL) [Срок оценки: 12 months]
• UCLA Loneliness Scale (UCLA-3) [Срок оценки: 12 months]
• Health Status (Self-Rated Health) [Срок оценки: 12 months]
• Lubben Social Network Scale (LSNS-6) [Срок оценки: 12 months]
• Chair Stand Test [Срок оценки: 12 months]
• Grip Strength [Срок оценки: 12 months]
• Adapted Dementia Knowledge and Attitudes (14-item) [Срок оценки: 12 months]
• Partners in Health Scale (PIH) [Срок оценки: 12 months]
• Rapid Assessment of Physical Activity (RAPA) [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

Сингапур · 1 центр

• Alexandra Hospital — Singapore

Публикации

• Kashdan TB, Disabato DJ, Goodman FR, et al. The Five-Dimensional Curiosity Scale Revised (5DCR): Briefer subscales while separating overt and covert social curiosity. Personality and Individual Differences 2020;157:109836.
• Virginia B, Victoria C. Using thematic analysis in psychology. Qualitative Research in Psychology 2006;3(2):77--101
• Guest G, Bunce A, Johnson L. How Many Interviews Are Enough?:An Experiment with Data Saturation and Variability. Field Methods 2006;18(1):59-82
• Lubben JE. Assessing social networks among elderly populations. Family & Community Health 1988;11(3):42-52.
• Petkov J, Harvey P, Battersby M. The internal consistency and construct validity of the partners in health scale: validation of a patient rated chronic condition self-management measure. Qual Life Res. 2010 Sep;19(7):1079-85. doi: 10.1007/s11136-010-9661-1. Epub 2010 May 1. PMID 20437206
• Balestroni G, Bertolotti G. [EuroQol-5D (EQ-5D): an instrument for measuring quality of life]. Monaldi Arch Chest Dis. 2012 Sep;78(3):155-9. doi: 10.4081/monaldi.2012.121. Italian. PMID 23614330
• Matthews JA, Matthews S, Faries MD, Wolever RQ. Supporting Sustainable Health Behavior Change: The Whole is Greater Than the Sum of Its Parts. Mayo Clin Proc Innov Qual Outcomes. 2024 May 18;8(3):263-275. doi: 10.1016/j.mayocpiqo.2023.10.002. eCollection 2024 Jun. PMID 38807973
• Bowen PG, Jones CD, Myers T, Martin R, Knight A, Azuero A, Smith T, Lancaster C, Brewer M, Davuluri S, Delaney E, Asif I, Lazar RM. Implementing brain health strategies in primary care: methods and baseline findings from the BHAM registry. Arch Public Health. 2025 Dec 29;83(1):306. doi: 10.1186/s13690-025-01768-0. PMID 41462348

Идентификаторы

NCT: NCT07612800 · 2025-1562 · NICCOG2024-0027

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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