ADL+2.0: Intervention for Prevention of Cognitive Decline in Community-dwelling Older Adults.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 255
- 试验地点
- 1
- 主要终点
- Cognitive test performance
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥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.
排除标准
- •Known dementia or suspected dementia after initial screening
- •Significant medical illnesses
结局指标
主要结局
Cognitive test performance
时间窗: Through study completion, an average of 9 months
The primary efficacy outcome will be change in cognitive test performance in composite and individual domain z- scores using a standardised neuropsychological test battery (NTB) comprising the 5 domains of attention, processing speed, memory, language, and executive function.
次要结局
- Efficacy outcomes - Cognition(through study completion, an average of 9 month)
- Efficacy outcomes - Function & Social(through study completion, an average of 9 month)
- Efficacy outcomes - Quality of Life(through study completion, an average of 9 month)