NCT07477561

Brief Summary

The goal of this intervention study is to screen and identify frailty and decline in intrinsic capacity (physical and mental capacities) in community-dwelling older adults in Singapore, and to evaluate whether early identification and targeted interventions can improve health outcomes and support healthy ageing. The main questions it aims to answer are:

  • Can combined frailty and intrinsic capacity screening with targeted interventions prevent or reduce functional decline in older adults, as measured by changes in life space mobility?
  • Will at least 80% of screened older adults adhere to recommended care pathways and interventions?
  • Can this screening and intervention programme demonstrate sustainability through continued community participation and recruitment of new partner organizations beyond the initial implementation phase? The investigators will compare an intervention group (receiving immediate assessment and clinical referrals based on identified needs) to a wait-list control group (receiving the same interventions 12 months later) to see if early intervention leads to better health outcomes and quality of life. Participants will:
  • Attend 4 study visits over 2 years (at 6-monthly intervals in the first year, with final assessment at end of year 2), each lasting up to 2 hours.
  • Undergo comprehensive screening assessments including mobility, cognition, mental health, hearing, vision, and nutritional status.
  • Receive 2 follow-up phone calls at 3-month and 9-month intervals to monitor progress.
  • If in the intervention group: receive personalized referrals for further care (which may include comprehensive geriatric assessment, primary care reviews, rehabilitation, or dietitian consultations) and guidance on using a mobile health monitoring application.
  • If in the wait-list control group: receive the same interventions after their 3rd study visit (12 months later).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Jul 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
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%
Jul 2023Jan 2028

Study Start

First participant enrolled

July 17, 2023

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2028

Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

4 years

First QC Date

March 1, 2026

Last Update Submit

April 14, 2026

Conditions

Keywords

FrailtyIntrinsic capacity declineCommunity-dwelling older adultsAge-related functional declineHealthy ageingEarly identification and management of frailty and functional decline

Outcome Measures

Primary Outcomes (2)

  • Life space mobility

    To maintain functional independence in older adults, represented by life space mobility (LSM). LSM will be assessed using the University of Alabama Life Space Assessment (LSA) questionnaire. This tool measures the extent of an older adult's movement within their environment, reflecting their community participation and functional independence. The outcome will be expressed as the LSM score, a numerical value derived from the LSA questionnaire, indicating the spatial extent and frequency of movement over the last 4 weeks.

    From enrollment to the end of intervention at 12 months.

  • Community implementation outcomes of INFINITY-ICOPE programme

    Fidelity: Measured by adherence rates (%) to protocol specifications and intervention delivery as intended, assessed through structured fidelity checklists completed by implementation staff. Penetration: Measured as the proportion (%) of eligible older adults reached and enrolled from target community settings, based on programme enrollment records. Sustainability: Measured by the continued operation of the programme and ongoing partner engagement, assessed through documentation of programme activities and partner participation rates (%) beyond the initial implementation period. Follow-up telephone interviews will be conducted at 3 and 9 months post-enrollment to assess participants' self-reported adherence using a standardized questionnaire. Pre- and post-screening surveys with community and primary care providers will evaluate their experience with the INFINITY-ICOPE programme through Likert-scale items, informing programme refinements.

    Fidelity: Assessed continuously throughout the 24-month study period. Penetration: Measured at 12 months and 24 months. Sustainability: Evaluated at 24 months and 6 months post-study completion (30 months total).

Secondary Outcomes (5)

  • Adherence to automated frailty screening and remote intrinsic capacity monitoring

    Assessed at baseline, 6, 12, and 24 months.

  • Prevention of frailty progression and preservation of intrinsic capacity

    Assessed at baseline, 6, 12, and 24 months.

  • Health-related quality of life improvement

    Assessed at baseline, 6, 12, and 24 months.

  • Healthcare service utilization

    Assessed at baseline, 6, 12, and 24 months.

  • Association between oral frailty and physical frailty for risk stratification

    Assessed at baseline, 6, 12, and 24 months.

Study Arms (2)

Intervention with further assessment and clinical referrals based on needs identified

ACTIVE COMPARATOR

Participants will receive personalized referrals for further care (which may include comprehensive geriatric assessment, primary care reviews, rehabilitation, or dietitian consultations) and guidance on using a mobile health monitoring application.

Other: INFINITY-ICOPE programme

Wait-listed control

OTHER

Participants will continue usual care at active ageing centres and receive the same interventions after their 12-month assessment.

Other: INFINITY-ICOPE programme

Interventions

The INFINITY-ICOPE programme will involve (i) integrated frailty and intrinsic capacity screening, (ii) referral to comprehensive geriatric assessment for frail participants or pathways adapted from the WHO-ICOPE approach for non-frail seniors with intrinsic capacity decline, (iii) 6-monthly self-monitoring for IC and frailty supported through the ENGAGE app and SCREENii.

Intervention with further assessment and clinical referrals based on needs identifiedWait-listed control

Eligibility Criteria

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

You may qualify if:

  • Any Singaporean or Permanent Resident (PR) aged 60 years and above
  • Able to provide informed consent (or legally acceptable representative available)

You may not qualify if:

  • Non-Singaporeans or non-PRs under 60 years of age
  • Residents of sheltered or nursing homes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sengkang General Hospital

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Laura Bee Gek Tay

    Sengkang General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Denise Qian Ling Chua

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: Participants in wait-listed control centre will cross over to active intervention after 12 months.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Consultant

Study Record Dates

First Submitted

March 1, 2026

First Posted

March 17, 2026

Study Start

July 17, 2023

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

January 15, 2028

Last Updated

April 17, 2026

Record last verified: 2026-04

Locations