ADL+2.0: Intervention for Prevention of Cognitive Decline in Community-dwelling Older Adults

Официальное название

ADL+2.0: Intervention for Prevention of Cognitive Decline in Community-dwelling Older Adults.

Обзор

Singapore's rising dementia incidence with an ageing population presents an urgent need for effective interventions that delay or prevent cognitive decline. While multi-domain intervention studies for dementia prevention show promise, there is a need for an effective personalised approach to address an individual's multifactorial risks for dementia, and to achieve cost-effective, scalable and sustainable outcomes for wider implementation. The investigators propose the ADL+ 2.0 programme, an overall goal is to delay or prevent cognitive decline in at-risk individuals without dementia aged 60 and above with subjective memory complaints and/or impaired cognitive capacity from the ICOPE screening tool. Through a population-level, technology-enabled, community-based preventative approach, ADL+ 2.0 provides remote assessment and multi-component intervention (cognitive training, dual-task exercises, and cognitive wellness) with smart scheduling and personalized intervention, and can be delivered in conjunction with the onsite 6 WELLS facilitated group-based activity, underpinned by the Self-Determination Theory to foster intrinsic motivation for lasting behavioural change. The approach begins with phase 1 test-bedding approach Type 1 hybrid effectiveness-implementation study to ascertain the efficacy, cost-effectiveness, and implementation of the ADL+ 2.0 programme. The investigators will conduct a 3-arm cluster-randomised controlled trial comparing remote/onsite, remote only, and control groups to assess the impact on cognitive outcomes, social networks, quality-of-life and cost-effectiveness. Barriers and facilitators will be identified for implementation, guided by the Consolidated Framework for Implementation Research. Together with NTU-LILY/LKCMedicine as technology partner and community partners (NTUC Health, Fei Yue Community Services, and evaluation partners (GERI/NUS) to provide evidence for and effectively implement a scalable, sustainable, and cost-effective community programme for the prevention of cognitive decline in Singapore.

Подробное описание

An estimated one in 10 people aged 60 and above in Singapore suffers from dementia. With increasing life expectancy and a rapidly ageing population, the number of persons living with dementia is expected to continue to rise, with significant negative consequences at individual, societal and healthcare system levels. To address this problem, multidomain non-pharmacological interventions aimed at addressing various risk factors for dementia prevention hold promise. However, a gap exists in overcoming practical barriers, demonstrating cost-effectiveness, and ensuring scalability and sustainability of these interventions.

To address these gaps, the investigators propose ADL+ 2.0: Intervention for prevention of cognitive decline in community-dwelling older adults. The ADL+ 2.0 programme takes a population-level, technology-enabled, community- based preventative approach, targeting community-dwelling individuals without dementia aged 60 years and above who are at risk of cognitive decline. Type 1 hybrid effectiveness-implementation study will be conducted to ascertain the efficacy, cost-effectiveness, and implementation of the ADL+ 2.0 programme.

Firstly, to determining the effectiveness of the ADL+ 2.0 programme in improving cognition, social participation, and health-related quality of life amongst older persons at risk of cognitive decline serves as a pre- requisite before further implementation and scaling in the community. Secondly, determining the cost-effectiveness of the ADL+ 2.0 programme is important to understand the funding and resource implications for longer-term sustainability. Lastly, explicating the facilitators and barriers for participation/adherence at the individual user level and delivery of programme at the systems level will enable the study team to develop implementation strategies and further refine and develop the ADL+ 2.0 intervention in the scale up (deployment) phase.

Вмешательства

• Другое Combined: Mobile app + 6WELLS
  Mobile based digital toolkit for cognitive health, remote assessment and multi-component intervention, comprising the 4 key pillars of assessment; cognitive training and stimulation; cognitive wellness; and dual-task training. Together with onsite 6 WELLS Group-Based Activity is a structured, group-based, cognitive health promotion programme that aims to build communities of practice, stimulate goal attainment, and drive behavioural change towards cognitive health and wellbeing. The curriculum i
• Другое Remote mobile based app
  Mobile based digital toolkit for cognitive health, remote assessment and multi-component intervention, comprising the 4 key pillars of assessment; cognitive training and stimulation; cognitive wellness; and dual-task training.

Первичные конечные точки

• Cognitive test performance [Срок оценки: Through study completion, an average of 9 months]

Вторичные конечные точки (3)

• Efficacy outcomes - Cognition [Срок оценки: through study completion, an average of 9 month]
• Efficacy outcomes - Function & Social [Срок оценки: through study completion, an average of 9 month]
• Efficacy outcomes - Quality of Life [Срок оценки: through study completion, an average of 9 month]

Критерии участия

Критерии включения

• ≥60 Years old
• Participants from partnering Active Ageing Centres (AACs) across Singapore
• Subjective memory complaint (AD8 ≥ 2)
• Independent in activities of daily living (ADL)
• Able to speak English and/or Mandarin
• Comfortable with using smartphones
• Not currently enrolled in a formal cognitive training program.

Критерии исключения

• Known dementia or suspected dementia after initial screening
• Significant medical illnesses

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Сингапур · 1 центр

• Tan Tock Seng Hospital — Singapore

Идентификаторы

NCT: NCT07141160 · ECOS Ref 2024-4524

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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