- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07525583
Implementation of Decade of Healthy Ageing Action Plan to Screen and Prevent Decline in Intrinsic Capacity in Elders (SPICE) Through Multisectoral Collaboration in Singapore (SPICE)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Population ageing is associated with progressive decline in intrinsic capacity (IC), defined by WHO as the composite of physical and mental capacities across mobility, cognition, vitality (nutrition), psychological, and sensory domains. Early detection of IC decline enables preventive, person-centred interventions to delay frailty, disability, and long-term care dependency.
The SPICE study operationalises the WHO ICOPE framework within Singapore's community ageing ecosystem through a coordinated hub-and-spoke model linking:Community screening platforms (e.g., Active Ageing Centres), Community Health Posts, Regional health system services and other social service organisations.
The pathway consists of:
Step 1: IC Screening
- Screening using WHO ICOPE Monitor tools. Step 2: In-Depth Assessment
- Participants screening positive for decline undergo structured assessment of affected domains.
Step 3: Risk Stratification & Care Planning
- Traffic-light classification (low, moderate, high risk) with personalised care plans.
Step 4: Intervention & Referral
- Multidomain community interventions (exercise, nutrition, cognitive stimulation, psychosocial engagement) or escalation to medical services when required.
Step 5: Monitoring & Follow-up
- Longitudinal follow-up with repeat IC assessments at defined intervals. The study will evaluate implementation feasibility, prevalence of IC decline, adherence to care pathways, functional outcomes, and cost-effectiveness within a real-world community system.
In addition, blood and digital biomarkers will be collected from a subgroup of study participants.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Reshma Merchant (Associate Professor), MBChB (Edin)
- Phone Number: +6567724368
- Email: mdcram@nus.edu.sg
Study Locations
-
-
-
Singapore, Singapore
- Recruiting
- National University Hospital
-
Contact:
- Sophie Swe Mar Tun
- Phone Number: +6589129558
- Email: mdcv613@partner.nus.edu.sg
-
Principal Investigator:
- Reshma Merchant, MBChB
-
Sub-Investigator:
- Li Feng Tan, MBBS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- pre-frail or robust older adults who can provide consent and follow instructions
Exclusion Criteria:
- frail or with terminal illness
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Screen and Prevent Intrinsic Capacity Decline in Elders (SPICE)
Community-dwelling adults robust or pre-frail aged 60 years and above who undergo WHO ICOPE-aligned digital intrinsic capacity screening, structured risk stratification, personalised multidomain community-based interventions, and longitudinal follow-up.
|
Participants will undergo baseline intrinsic capacity (IC) screening using WHO ICOPE-aligned tools in community settings. Follow-up contacts/visits will occur over the study period and include:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prevalence of intrinsic capacity decline at baseline (robust / pre-frail)
Time Frame: Baseline
|
Proportion of participants (restricted to robust and pre-frail at baseline) with ≥1 impaired IC domain on screening; and proportion impaired by each domain (mobility, cognition, vitality, psychological, sensory).
|
Baseline
|
|
Uptake of recommended actions (implementation effectiveness)
Time Frame: Up to 3 months post-recommendation
|
Proportion of participants who initiate at least one recommended action within a defined window after screening/plan (e.g., enrolment in a prescribed community programme, completion of recommended assessment, or attendance at a referred service).
|
Up to 3 months post-recommendation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Identification of (a set of) biomarkers of aging
Time Frame: 30 months
|
Both blood biomarkers and digital markers associated with various intrinsic capacity
|
30 months
|
|
Feasibility and reach
Time Frame: 30 months
|
Proportion of individuals in each community setting complete both Step 1 and Step 2 assessment.
|
30 months
|
|
Change in intrinsic capacity and function over time
Time Frame: 12 months from enrolment
|
Change in number of impaired IC domains (0-5) from baseline to follow-up.
|
12 months from enrolment
|
|
Frailty progression
Time Frame: over 12 months follow up
|
Proportion transitioning from robust → pre-frail/frail; pre-frail → frail
|
over 12 months follow up
|
|
Cost per participant screened
Time Frame: 3 years
|
Programme delivery cost from the provider/programme perspective, calculated as total programme delivery cost divided by the number of participants screened; costs include personnel, training, digital platform/monitoring, screening and assessment delivery, and intervention coordination.
|
3 years
|
|
Number of participants with at least one unscheduled emergency department visit or hospital admission
Time Frame: 12 months
|
Number and proportion of participants with at least one unscheduled emergency department visit or unplanned hospital admission during follow-up, based on participant report and/or clinical records where available.
|
12 months
|
|
Implementation outcomes assessed using RE-AIM framework
Time Frame: 3 years
|
Reach: Proportion of eligible older adults screened, characteristics of participants. Effectiveness: Proportion of participants with identified IC impairment who receive recommended follow-up actions, including referral to community services, primary care, or multidisciplinary assessment. Adoption: Provider-reported acceptability and perceived usefulness of the screening pathway (measured using an adapted 8-item questionnaire based on the Theoretical Framework of Acceptability (TFA)). Implementation: Adherence to screening protocols among providers, completion of Step 1 and Step 2 assessments, and referral processes. Implementation strategies, barriers, and facilitators will also be documented by qualitative method. Maintenance: Continued delivery of IC screening at participating sites, and Integration of the programme into routine community health services. The 23-item Normalization Measure Development questionnaire (NoMAD) and the 12-item SCIROCCO tool will be used. |
3 years
|
Collaborators and Investigators
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NICTran2023-0013 (Other Grant/Funding Number: National Medical Research Council)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Frailty
-
University of PennsylvaniaCompleted
-
McMaster UniversityRecruitingFrailty | Frailty Syndrome | Frail Older Adults | Frailty in AgingCanada
-
University of IcelandLandspitali University HospitalRecruitingFrailty Syndrome | Elective Surgery | Frailty in Adult SurgeryIceland
-
Universidad Francisco de VitoriaNot yet recruitingFrailty Syndrome | Respiratory Muscle Weakness | Age-Related Frailty | Geriatric Health
-
Universidad Francisco de VitoriaActive, not recruitingFrailty Syndrome | Respiratory Muscle Weakness | Age-Related Frailty | Geriatric HealthSpain
-
Ji Yan Biomedical Co., Ltd.YC Biotech Co., Ltd.Not yet recruiting
-
Universidad Francisco de VitoriaNot yet recruitingFrailty Syndrome | Respiratory Muscle Weakness | Age-Related Frailty | Geriatric Health
-
University of NottinghamRecruitingFrailty | Diet | Systemic Inflammatory Response | Dietary Fiber | Frailty at Older Adults | Pre-FrailtyUnited Kingdom
-
National Taipei University of Nursing and Health...Not yet recruiting
-
IRCCS Centro San Giovanni di Dio FatebenefratelliCompleted