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Mild Cognitive ImpairmentNCT07099040

Community-based Multi-domain Intervention to Detect and Delay Cognitive Decline in Community-dwelling Older Adults: A Pilot Study

A study testing Social support, Health coaching and Physical Activity in people with Mild Cognitive Impairment and Mild Cognitive Impairment (MCI), run by Singapore General Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
What is being tested?
Social support, Health coaching and Physical Activity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
No sites listed yet
Study dates
12 Aug 2025to 30 Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Older Adults:
  • 60 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,
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  • able to provide consent.
  • Caregivers:
  • 21 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:
  • 21 years and older,
  • English and/or Mandarin speaking,
  • able to provide consent.
  • Youth Volunteers:
  • volunteers from Youth Corps Singapore (YCS)
  • English and/or Mandarin speaking,
  • able to provide assent

Who cannot join

  • 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,
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  • 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).
  • Care providers:
  • not working for the older population,
  • Not being able to read, write, and converse in English/Mandarin,
  • have not provided service during the period of the pilot test for at least one month (1 session of cognitive activity/week, 2 sessions of physical activity/week).

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Research coordinators contact

62223222

impress.minds@singhealth.com.sg

About this study

Official title: IMPlementation stRategiEs for Scalability and Sustainability - Multidomain INterventions in a Structured Care Pathway to Detect and Delay Cognitive Decline in Community-dwelling Older Adults (IMPRESS-MIND2S): Pilot Test

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.

Being tested
Social support, Health coaching, Physical Activity, Cognitive activity
Keywords
Multi-domain intervention, Pilot study, Community-based intervention, Cognitive Impairment
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Social supportBehavioural

    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.

  • Health coachingBehavioural

    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.

  • Physical ActivityBehavioural

    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.

  • Cognitive activityBehavioural

    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.

Study groups in NCT07099040
Study groupRoleWhat they receive
InterventionExperimentalTwice 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
Receives: Behavioral: Social support; Behavioral: Health coaching; Behavioral: Physical Activity; Behavioral: Cognitive activity
ControlNo interventionUsual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From enrollment to the end of month 6

Secondary outcomes (16)

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

    The Short Physical Performance Battery (SPPB) assesses lower extremity function in older adults by evaluating standing balance, gait speed, and repeated chair stands, with scores ranging from 0 to 12, where higher scores indicate better function.

    Measured: From enrollment to the end of month 6

  2. Care recipients' frailty measured by FRAIL scale

    The FRAIL scale (Fatigue, Resistance, Ambulation, Illnesses, and Loss of weight) is a clinical screening tool used to identify frailty in older adults.

    Scoring breakdown:

    • Each component is scored as 0 or 1
    • Minimum total score: 0
    • Maximum total score: 5

    Higher scores indicate worse outcomes/greater frailty:

    The five components are scored as follows:

    • Fatigue: "Are you fatigued?" (Yes = 1, No = 0)
    • Resistance: "Can you climb one flight of stairs?" (No = 1, Yes = 0)
    • Ambulation: "Can you walk one block?" (No = 1, Yes = 0)
    • Illnesses: Having 5 or more illnesses (Yes = 1, No = 0)
    • Loss of weight: >5% weight loss in past 6 months (Yes = 1, No = 0)

    Measured: From enrollment to the end of month 6

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

    EuroQol 5-Dimension 5-Level (EQ-5D-5L)

    For the individual dimension scores (Mobility, Self-care, Usual activities, Pain/discomfort, Anxiety/depression):

    • Minimum value: 1
    • Maximum value: 5
    • Higher scores = Worse health outcomes

    Measured: From enrollment to the end of month 6

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

    For the EuroQol Visual Analogue Scale (EQ VAS):

    • Minimum value: 0
    • Maximum value: 100
    • Higher scores = Better health outcomes

    Measured: From enrollment to the end of month 6

  5. Caregivers' caregiving burden measured by Zarit burden interview (ZBI)

    The Zarit Burden Interview-12 (ZBI-12) or Short Version of Zarit Burden Interview:

    • Minimum score: 0
    • Maximum score: 48
    • Higher scores indicate greater caregiver burden

    Scoring interpretation:

    • 0-10: No to mild burden
    • 11-20: Mild to moderate burden
    • 20: High burden

    Measured: From enrollment to the end of month 6

  6. Care recipients' ability to perform more complex tasks necessary for independent living within the community - Measured by Lawton scale iADL

    Each item in iADL is rated based on the person's ability to perform the task independently, with some versions scoring:

    0 = unable or needs help

    1 = independent

    Total scores range from 0 (low function, dependent) to 8 (high function, independent).

    Measured: From enrollment to the end of month 6

  7. Feasibility outcome - Acceptability, collected from the Acceptability of Intervention Measure (AIM)

    AIM has 4 items describing participants' acceptance of the intervention. Each item has 5 possible options, with scoring

    1. - Completely disagree
    2. - Disagree
    3. - Neither agree nor disagree
    4. - Agree
    5. - Completely agree

    Measured: At the end of months 2, 4, and 6

  8. Feasibility outcome - Perceived appropriateness, collected from the Intervention Appropriateness Measure (IAM)

    IAM has 4 items describing participants' acceptance of the intervention. Each item has 5 possible options, with scoring

    1. - Completely disagree
    2. - Disagree
    3. - Neither agree nor disagree
    4. - Agree
    5. - Completely agree

    Measured: At the end of months 2, 4, and 6

  9. Feasibility outcome - Perceived feasibility, collected from the Feasibility of Intervention Measure (FIM)

    FIM has 4 items describing participants' acceptance of the intervention. Each item has 5 possible options, with scoring

    1. - Completely disagree
    2. - Disagree
    3. - Neither agree nor disagree
    4. - Agree
    5. - Completely agree

    Measured: At the end of months 2, 4, and 6

  10. Feasibility outcome - Care recipients' perceptions of the intervention, collected from qualitative interview

    Measured: Month 6

  11. Feasibility outcome - Acceptability, collected from the Acceptability of Intervention Measure (AIM)

    AIM has 4 items describing participants' acceptance of the intervention. Each item has 5 possible options, with scoring

    1. - Completely disagree
    2. - Disagree
    3. - Neither agree nor disagree
    4. - Agree
    5. - Completely agree

    Measured: Month 6

  12. Feasibility outcome - Perceived appropriateness, collected from the Intervention Appropriateness Measure (IAM)

    IAM has 4 items describing participants' acceptance of the intervention. Each item has 5 possible options, with scoring

    1. - Completely disagree
    2. - Disagree
    3. - Neither agree nor disagree
    4. - Agree
    5. - Completely agree

    Measured: Month 6

  13. Feasibility outcome - Perceived feasibility, collected from the Feasibility of Intervention Measure (FIM)

    FIM has 4 items describing participants' acceptance of the intervention. Each item has 5 possible options, with scoring

    1. - Completely disagree
    2. - Disagree
    3. - Neither agree nor disagree
    4. - Agree
    5. - Completely agree

    Measured: Month 6

  14. Feasibility outcome - Caregivers' perceptions of the intervention, collected from qualitative interview

    Measured: Feasibility outcome - Caregivers' perceptions of the intervention, collected from qualitative interview

  15. Feasibility outcome - Acceptability, collected from the Acceptability of Intervention Measure (AIM)

    AIM has 4 items describing participants' acceptance of the intervention. Each item has 5 possible options, with scoring

    1. - Completely disagree
    2. - Disagree
    3. - Neither agree nor disagree
    4. - Agree
    5. - Completely agree

    Measured: From enrollment to the end of month 6

  16. Feasibility outcome - Caregivers' perceptions of the intervention, collected from qualitative interview

    Measured: Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2025
  2. Study start12 Aug 2025 (estimated)
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
170 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07099040
Sponsor's protocol ID
202503-0001
Other IDs
NICTran2023-0014
Status last verified
Jul 2025
First submitted
23 Mar 2025
Last updated
1 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Social support, Health coaching and Physical Activity in people with Mild Cognitive Impairment and Mild Cognitive Impairment (MCI), run by Singapore General Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Research coordinators (62223222, impress.minds@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Care recipients' cognition measured by the Montreal Cognitive Assessment (MoCA) (time frame: From enrollment to the end of month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07099040.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.

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