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

NCT ID: NCT07141160

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

255 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-08

Study Completion Date

2029-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cognitive Decline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a type 1 hybrid effectiveness-implementation to ascertain the efficacy, cost-effectiveness, and implementation of the ADL+ 2.0 programme. The effectiveness study will use a cluster randomised trial design that compares 3 participant groups: a) receiving a combination of remote and onsite interventions, b) receiving only remote interventions, and c) education booklet + health talk group.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Combined: Mobile app + 6WELLS

Intervention Type 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.

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

Group Type EXPERIMENTAL

Remote mobile based app

Intervention Type 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.

Educational booklet and health talk

Education booklet and a health talk on cognition. The booklet and health talk will be provided to the participants, it comprises of tips for maintaining cognitive health. Both aims to promote the awareness for normal ageing and dementia.

Group Type SHAM_COMPARATOR

Combined: Mobile app + 6WELLS

Intervention Type 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

Intervention Type 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.

Interventions

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

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nanyang Technological University

OTHER

Sponsor Role collaborator

Geriatric Education and Research Institute

OTHER_GOV

Sponsor Role collaborator

Tan Tock Seng Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wee Shiong Lim

Role: PRINCIPAL_INVESTIGATOR

Tan Tock Seng Hospital

Locations

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Tan Tock Seng Hospital

Singapore, , Singapore

Site Status

Countries

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Singapore

Other Identifiers

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ECOS Ref 2024-4524

Identifier Type: -

Identifier Source: org_study_id