NCT07099040

Brief Summary

The incidence of cognitive impairment and its burden are increasing with a rapidly ageing population. In Singapore, the prevalence of dementia among older adults aged 60 and above is approximately 10%, which will translate to approximately 152,000 older adults living with dementia by the year 2030. Using 2013 data as estimates, the total annual cost of dementia was already estimated at S$532 million while cost per person was estimated at S$10,245 per annum, and a further increase in corresponding costs is expected through 2030 with the projection of increase in persons with dementia (PWDs). There is thus an urgent need for (i) effective, scalable, and sustainable interventions that are widely accessible to detect and delay cognitive decline and frailty in our community-dwelling older adults, and (ii) providing support for their caregivers. This study aims to test the feasibility of a community-based multi-domain intervention for detecting and delaying cognitive impairment for the older population.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Aug 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress65%
Aug 2025Sep 2026

First Submitted

Initial submission to the registry

March 23, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 1, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

August 12, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

August 1, 2025

Status Verified

July 1, 2025

Enrollment Period

1.1 years

First QC Date

March 23, 2025

Last Update Submit

July 24, 2025

Conditions

Keywords

Multi-domain interventionPilot studyCommunity-based interventionCognitive Impairment

Outcome Measures

Primary Outcomes (1)

  • Care recipients' cognition measured by the Montreal Cognitive Assessment (MoCA)

    The MoCA (Montreal Cognitive Assessment) scoring ranges from 0 to 30, with a higher score indicates better cognitive function.

    From enrollment to the end of month 6

Secondary Outcomes (16)

  • Care recipients' physical function measured by short physical performance battery (SPPB)

    From enrollment to the end of month 6

  • Care recipients' frailty measured by FRAIL scale

    From enrollment to the end of month 6

  • Care recipients' health-related quality of life measured by EuroQol 5-Dimension 5-Level (EQ-5D-5L)

    From enrollment to the end of month 6

  • Care recipients' health state on a EuroQol Visual Analogue Scale (EQ VAS)

    From enrollment to the end of month 6

  • Caregivers' caregiving burden measured by Zarit burden interview (ZBI)

    From enrollment to the end of month 6

  • +11 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Twice of physical activity at the AAC with home-based exercises once to twice a week, and once a week of cognitive activity at the AAC, with once to twice a week of home-based activity

Behavioral: Social supportBehavioral: Health coachingBehavioral: Physical ActivityBehavioral: Cognitive activity

Control

NO INTERVENTION

Usual care

Interventions

Social supportBEHAVIORAL

Psychoeducation will be provided for enrolled participants and their caregivers by Community Resource, Engagement \& Support Team (CREST). Visits from CREST teams will be provided on an ad hoc basis, based on older adult participants' needs and circumstances.

Intervention
Health coachingBEHAVIORAL

Health coaching aims to control risk factors of dementia by community nurses (CMNs) and wellbeing coordinators (WBCs). These include addressing chronic conditions and lifestyle aspects (diet, exercise, habits stress management, and sleep). Care recipients are encouraged to proactively manage their health journey and establish Specific, Measurable, Achievable, Relevant, and Time-bound (SMART) goals with the support of WBCs and CMNs. This multi-faceted approach has the potential to not only address older individuals' immediate health concerns but also foster long-term lifestyle changes. The frequency of visits are once or twice a month, depending on recipients' health status and cognitive functions. Flexible scheduling is based on individual needs and community nurses' usual practice at the Community Health Post at AACs.

Intervention

Physical Activity that focuses on improving resistance and balance for care recipients. Physical activity will be conducted 2 times/week at the Active Ageing Centres (AACs) with care recipients for a duration of 1-hour and 1-2 times/week at home.

Intervention

Cognitive activity will be delivered to enrolled care recipients by Community Resource, Engagement \& Support Team (CREST) and AAC staff. With the incorporation of using SilverPad as part of the cognitive activities, care recipients will undergo 1-hour weekly cognitive activity. Youth volunteers will also be engaged to help facilitate the sessions. This will be augmented with additional 1-2 times weekly home-based training sessions supervised by caregivers.

Intervention

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Older Adults:
  • years and older with cognitive concerns or (self-reported or observer reported),
  • English and/or Mandarin speaking,
  • no physical disabilities that preclude study participation,
  • willing to complete all study-related activities,
  • no known diagnosis of major cognitive impairment,
  • able to provide consent.
  • Caregivers:
  • years and older,
  • English and/or Mandarin speaking,
  • able to provide consent
  • have at least 6-month experience of taking care of older adults with mild cognitive impairment.
  • Service providers:
  • years and older,
  • English and/or Mandarin speaking,
  • +5 more criteria

You may not qualify if:

  • Older adults
  • Known diagnosis of moderate dementia and above,
  • Montreal Cognitive Assessment (MoCA) score \<18,
  • Has difficulty in basic activities of daily living,
  • disorders that affects safe engagement in the intervention (e.g. symptomatic cardiovascular disease, revascularization within 1 year, major depression or anxiety with ongoing treatment, underlying malignancy),
  • Severe vision or hearing impairment or any other disorders preventing cooperation as judged by the study team,
  • Major illness with life expectancy \<6 months,
  • Institutionalized,
  • Planned major surgery within the duration of the multi-domain intervention,
  • Physical disabilities that preclude study participation.
  • Caregivers:
  • aged below 21 years old,
  • not being the primary family caregiver of at least one older individual,
  • not being able to read, write, and converse in English/Mandarin,
  • their family members (older adults) have not participated in the pilot test for at least one month (1 session of cognitive activity/week, 2 sessions of physical activity/week).
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Research coordinators

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2025

First Posted

August 1, 2025

Study Start

August 12, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

August 1, 2025

Record last verified: 2025-07