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

NCT07141160 | Enrolling By Invitation DMC

• 1 other identifier: ECOS Ref 2024-4524
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cognitive Decline

Keywords

Subjective memory complaints; Technology-enabled; Multi-component intervention; Cognitive decline; Intrinsic motivation; Prevention

Outcome Measures

Primary Outcomes (1)

• Cognitive test performance

  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.

  Through study completion, an average of 9 months

Secondary Outcomes (3)

• 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

Other Outcomes (3)

• Cost analysis evaluation

  through study completion, an average of 9 month

• IAM (Intervention Appropriateness Measure) score

  through study completion, an average of 9 month

• FIM (Feasibility of Intervention Measure) scale

  through study completion, an average of 9 month

Study Arms (3)

Remote mobile based app

EXPERIMENTAL

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.

Other: Combined: Mobile app + 6WELLS

Combined: Mobile app + 6WELLS

EXPERIMENTAL

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.

Other: Remote mobile based app

Educational booklet and health talk

SHAM COMPARATOR

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.

Other: Combined: Mobile app + 6WELLS; Other: Remote mobile based app

Interventions

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.

Educational booklet and health talk; Remote mobile based app

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.

Combined: Mobile app + 6WELLS; Educational booklet and health talk

Eligibility Criteria

• Age: 60 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

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

Sponsors & Collaborators

• Geriatric Education and Research Institute: collaborator
• Tan Tock Seng Hospital: lead
• Nanyang Technological University: collaborator

Study Sites (1)

Tan Tock Seng Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Wee Shiong Lim

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 26, 2025
• Study Start: May 8, 2025
• Primary Completion (Estimated): August 30, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: December 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)