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NCT Number: NCT07141160

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

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.

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Key information

Conditions

Cognitive Decline Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

60 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tan Tock Seng Hospital

Singapore

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥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.

Exclusion criteria

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

Treatment and study plan

Combined: Mobile app + 6WELLS

Other

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 is delivered via a 10-week onsite programme comprising weekly facilitated small-group activities centred on six key components.

Remote mobile based app

Other

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.

Primary outcomes

  1. Cognitive test performance

    Time frame: 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.

Secondary outcomes

  1. Efficacy outcomes - Cognition

    Time frame: through study completion, an average of 9 month

    The investigators will assess subjective memory complaints using the locally validated AD8 questionnaire. Possible scores range from 0-1 (normal cognition) to 2-8 (cognitive impairment is likely to be present).

  2. Efficacy outcomes - Function & Social

    Time frame: through study completion, an average of 9 month

    Investigators will look at the transfer of cognitive benefits to activities of daily living using the Alzheimer's Disease Cooperative Study- Activities of Daily Living Prevention Instrument (ADCS-PI). The ADCS-PI consists of 15 IADL tasks and 5 physical function questions. Lubben Social Network Scale (LSNS-6) will be used to assesses the domains of social isolation and Frenchay Acitivities Index to assess participation in social activities.

  3. Efficacy outcomes - Quality of Life

    Time frame: through study completion, an average of 9 month

    Health-related quality of life (QOL) will be assess using the 5-level EuroQol 5-dimension (EQ-5D-5L) to derive utility scores based on Singapore preference weights derived using an indirect interim mapping method, and to estimate quality adjusted life years (QALY). 11-item Control, Autonomy, Self-realisation, and Pleasure (CASP-11) tool, which was developed specifically to assess emotional QOL in older adults. CASP-11 has a total score range of 0 to 33. A higher score indicates a higher quality of life.

Other outcomes

  1. Cost analysis evaluation

    Time frame: through study completion, an average of 9 month

    Investigators will conduct a cost-effectiveness analysis based on two efficacy outcomes to determine the incremental cost-effectiveness ratio, namely the neuropsychological test battery (NTB) Z-score, and quality-adjusted life-years to be computed from EQ-5D results. An estimate of the implementation and intervention cost per study participant and cost per site. This will support a comparison of the two intervention arms (remote and onsite, remote only), and inform the study team on the resources required for Phase 2.

  2. IAM (Intervention Appropriateness Measure) score

    Time frame: through study completion, an average of 9 month

    To understand the implementation strategies, qualitative interviews will be conducted to understand the adherence of the ADL+ 2.0. The scale values range from 1 to 5, higher scores indicate greater appropriateness

  3. FIM (Feasibility of Intervention Measure) scale

    Time frame: through study completion, an average of 9 month

    To understand the implementation strategies, qualitative interviews will be conducted to understand the adherence of the ADL+ 2.0 with FIM (Feasibility of Intervention Measure) scale. The scale values range from 1 to 5, higher scores indicate greater feasibility.

Sponsors and collaborators

Lead sponsor

Tan Tock Seng Hospital

Other

Collaborators

  • Geriatric Education and Research Institute
  • Nanyang Technological University

Registry information

Official study title

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

Acronym: ADL+ 2

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Aug 26, 2025
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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