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Healthy AgeingIMPACTFrailNCT06753643

An Intrinsic Capacity Identification and Management Programme for Older Adults in Singapore's Primary Care

An observational study of Healthy Ageing and Frailty, run by Geriatric Education and Research Institute.

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 IMPACTFrail program is an intrinsic capacity (IC) identification and management program for mildly frail older adults. Specifically, it delivers the three-tier approach recommended in the National Frailty Strategy Policy Report. Read more about this study

Who is it for?
Ages 60 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Ageing, Frailty
What is being tested?
The IMPACTFrail programme
How many people
180 participants
Where
No sites listed yet
Study dates
1 Mar 2025to 28 Feb 2026
Phase
Observational
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 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Older adults will be polyclinic patients aged 60 years and above with CFS score 4 or 5 as assigned by a trained healthcare provider at the polyclinic. They should not have done any comprehensive geriatric assessment or be currently receiving geriatric specialist outpatient services. Healthcare staff can be polyclinic healthcare providers (e.g., polyclinic doctors, nurses, care coordinators, care managers, medical social workers). Healthcare administrators would be from the polyclinic leadership team, who are decision-makers who have the authority to make implementation decisions and are familiar with the overall frailty and IC management strategies in primary care in Singapore.

Who may be able to join

  • being a patient of the polyclinic site
  • aged 60 years and above
  • Clinical frailty score (CFS) of 4 - 5
  • Not done comprehensive geriatric assessment (CGA) in the past 12 months (based on available medical records or self-report)
  • Not a current patient of geriatric specialist outpatient clinic (based on available medical records or self-report).
  • aged 21 years and above
  • Involved in the IMPACTFrail program as an implementer and/or a healthcare administrator with authority to make implementation decisions.

Who cannot join

  • Do not meet inclusion criteria above
  • Healthcare Staff (for qualitative study)
  • Do not meet inclusion criteria above

Trial locations and contacts

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

About this study

Official title: Implementing the National Frailty Policy in Singapore's Primary Care: A Pilot Feasibility Study of The Intrinsic Capacity ProMotion in PrimAry Care for The Frail Program (IMPACTFrail)

The IMPACTFrail program is an intrinsic capacity (IC) identification and management program for mildly frail older adults. Specifically, it delivers the three-tier approach recommended in the National Frailty Strategy Policy Report. The program's core functions include the segmentation of older persons using the Clinical Frailty Scale (CFS) score followed by secondary IC screening for CFS 4 to 5 (Tier 1), follow-up clinical assessment to confirm IC losses (Tier 2) and needs-directed management and tracking of their health (Tier 3).

The investigator aims to conduct a multi-site feasibility study on a small group of older adult study participants (n=30 per polyclinic).

The feasibility study has a few components. First, a qualitative study will assess its feasibility (implementation, appropriateness, acceptability, practicality, adaptability) as perceived by older adults, healthcare providers, and healthcare administrators. Second, the investigator aims to collect process indicators to track its implementation progress. Third, program costs will be estimated. Fourth, the investigator will develop a logic model and theory of change, and cluster-specific detailed written program descriptions. Lastly, the investigator aims to triangulate the findings and assess the feasibility for larger-scale implementation. This study is guided by implementation science frameworks and guidelines for conducting feasibility studies.

Read the detailed description

Background:

The broad goal for older adults is to age well and have healthy ageing. WHO defines healthy ageing as "the process of developing and maintaining the functional ability that enables wellbeing in older age." Functional ability is about having the capabilities that enable all people to be and do what they have reason to value.

Frailty is a clinically recognisable state whereby an older person's ability to cope with daily or acute stressors is compromised as a result of vulnerability from age-related deterioration in physiological reserves and function across multiple organ systems. Frailty is associated with negative health outcomes and is expected to increase in Singapore's ageing population. The National Frailty Strategy Policy Report published in 2023 serves to guide the Singapore Ministry of Health (MOH) Frailty Policy Implementation Workgroup in implementing the National Frailty Policy (NFP). One of the gaps identified in the report was the need for coordinated care and continuity of care across health and social service providers for frail older adults. To address this gap in Singapore's primary care setting, the IMPACTFrail program's core functions are to conduct segmentation of older people by using the Clinical Frailty Scale (CFS) score followed by secondary intrinsic capacity (IC) screening of six domains (locomotion, vision, hearing, vitality, cognition, psychological capacity) for CFS 4 and 5 (Tier 1), follow-up assessments based on IC deficits detected at screening (Tier 2), and coordination, management, and tracking (Tier 3). This study aims to co-develop IMPACTFrail's intervention components and implementation strategies in a small number of polyclinics and test its feasibility using implementation research in real-world local contexts.

Methods:

Prior to this pilot feasibility study, the investigators co-developed the innovation and implementation strategies among GERI, polyclinic cluster representatives, and implementers. This will be guided by the UK Medical Research Council's Framework (MRC) for developing and evaluating complex interventions and Framework of Actions for Intervention Development (FAID). Informal FGDs and interviews with stakeholders were conducted and the findings used to inform the development of the innovation. ERIC strategies will be selected to address CFIR barriers identified from the FGDs/interviews and specify and develop them.

Here, the investigators aim to conduct a multi-site feasibility study, with a few components. Each polyclinic has highly contextualised barriers, workflows, and infrastructure. Thus, each polyclinic is conceptualised as a single site for feasibility testing. There is no comparator arm.

First, FGDs/IDIs will be conducted to assess the program's feasibility (implementation, acceptability, practicality, adaptability) as perceived by older adults, healthcare providers, and healthcare administrators.

Second, the investigators aim to collect process indicators to track the program's implementation progress.

Third, program costs will be estimated.

Fourth, the investigators will develop a logic model and theory of change, and cluster-specific detailed written program descriptions.

Lastly, the investigators aim to triangulate our findings and assess the feasibility for larger-scale implementation.

This study is guided by implementation science frameworks and guidelines for conducting feasibility studies.

Discussion:

This project aims to improve the lives of older people through early detection and management of IC deficits for those with mild frailty (CFS 4-5) in primary care. This promotes longer-term outcomes including functional ability, improved quality of life, reduced healthcare use, and lower mortality.

Additionally:

First, the project translates evidence on the optimisation of IC and functional ability for healthy ageing to practice and policy in Singapore's primary care. Second, there is knowledge creation. This study contributes to the local evidence on screening and management strategies for delaying frailty progression by addressing IC deficits in frail older persons. The investigators inform the adaptations to implement the WHO ICOPE framework in local primary care contexts. Additionally, the project contributes to a better understanding on the optimisation of resources to groups who may benefit the most, by targeting CFS 4 and 5 for IC screening and delivering resource-intensive assessment and downstream interventions to this subgroup. Third, this study involves engaging all three clusters from the outset to accelerate national-level implementation and scaling up.

Additionally, to increase the likelihood of scalability, the investigators will involve 3 clusters and 1-2 polyclinics from each cluster. Fourth, the study offers opportunities for knowledge exchange.

Lastly, the project is aligned with national strategies like HealthierSG (informs frailty protocols for management in primary care), Age Well SG (enables frail community-dwelling persons to age in place), and the 2023 Action Plan for Successful Ageing (optimising IC and functional ability through a health program).

Being tested
The IMPACTFrail programme
Medical subject headings
Frailty

What participants receive

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

  • The IMPACTFrail programmeOther

    The IMPACTFrail programme

Study groups in NCT06753643
Study groupRoleWhat they receive
Older Adults (programme recipients)These are the recipients of the new programme in this feasibility study. Main study components of direct involvement. Qualitative - Focus group discussions or in-depth interviews with programme recipients Quantitative - Monitoring process indicators
Receives: Other: The IMPACTFrail programme

What is being measured

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

  1. Qualitative study 1

    What will be measured:

    Deviations to the intended execution of the programme and implementation strategies and reasons for changes made.

    How will it be measured:

    Via in-depth interviews (IDIs) and focus group discussions (FGDs) with healthcare administrators and healthcare providers.

    All participants for the qualitative study will be identified through purposive sampling. We will adopt the Rapid Qualitative Inquiry (RQI) approach in data analysis.

    Measured: Mar 2025 - Feb 2026

  2. Qualitative study 2

    What will be measured:

    Barriers/facilitators of implementing/receiving the programme and its implementation strategies.

    How will it be measured:

    Via in-depth interviews (IDIs) and focus group discussions (FGDs) with healthcare administrators, healthcare providers, and older adults.

    All participants for the qualitative study will be identified through purposive sampling. We will adopt the Rapid Qualitative Inquiry (RQI) approach in data analysis.

    Measured: Mar 2025 - Feb 2026

  3. Qualitative study 3

    What will be measured:

    Perspectives on the ability to deliver innovation with given resources (manpower, infrastructure, IT, others).

    How will it be measured:

    Via in-depth interviews (IDIs) and focus group discussions (FGDs) with healthcare administrators and healthcare providers.

    All participants for the qualitative study will be identified through purposive sampling. We will adopt the Rapid Qualitative Inquiry (RQI) approach in data analysis.

    Measured: Mar 2025 - Feb 2026

  4. Qualitative study 4

    What will be measured:

    Suggestions on how to improve the implementation of the programme for scalability and sustainability.

    How will it be measured:

    Via in-depth interviews (IDIs) and focus group discussions (FGDs) with healthcare administrators and healthcare providers.

    All participants for the qualitative study will be identified through purposive sampling. We will adopt the Rapid Qualitative Inquiry (RQI) approach in data analysis.

    Measured: Mar 2025 - Feb 2026

  5. Programme cost

    The aim is to inform the funding of resources (developmental cost e.g., training, new materials, innovation cost and cost of implementation strategies needed to scale up the programme).

    Programme costs will be derived by aggregating expenditures from financial statements on operating expenses, manpower, training, and equipment cost incurred, and obtaining the time spent by healthcare workers to actualise the delivery of the program.

    Measured: Mar 2025 - Feb 2026

  6. Logic model and theory of change

    What will be measured:

    The output is a single figure. We aim to depict a visual representation of the resources, key activities, outputs, outcomes, and plausible causal pathways connecting them.

    Measured: Mar 2025 - Feb 2026

  7. Written programme description

    What will be reported:

    The investigators will report the narrative detailed description of the programme.

    How will it be measured or reported: The frameworks used are TIDIER and AIMD.

    Measured: Mar 2025 - Feb 2026

  8. Process indicators

    What will be measured:

    Number of older adults with Clinical frailty scale (CFS) score 4-5, number of older adults who completed intrinsic capacity screening, number of older adults who actualised follow-up appointments.

    How will it be measured: Data collection will be from healthcare providers on the ground.

    Measured: Mar 2025 - Feb 2026

  9. Fidelity of implementation strategy: Educational meetings, Part 1

    What will be measured:

    Actor: Who executed the educational meetings.

    How will it be measured: Data collection will be from healthcare providers on the ground.

    Measured: Mar 2025 - Feb 2026

  10. Fidelity of implementation strategy: Educational meetings, Part 2

    What will be measured:

    Action target: Who attended the meetings

    How will it be measured: Data collection will be from healthcare providers on the ground.

    Measured: Mar 2025 - Feb 2026

  11. Fidelity of implementation strategy: Educational meetings, Part 3

    What will be measured:

    Temporality: Frequency of meetings

    How will it be measured: Data collection will be from healthcare providers on the ground.

    Measured: Mar 2025 - Feb 2026

  12. Fidelity of implementation strategy: Educational meetings, Part 4

    What will be measured:

    Dose: Number of meetings that each healthcare provider attended.

    How will it be measured: Data collection will be from healthcare providers on the ground.

    Measured: Mar 2025 - Feb 2026

  13. Fidelity of implementation strategy: Educational meetings, Part 5

    What will be measured:

    Action: Content (topics)/style (lecture, didactic) of educational meetings

    How will it be measured: Data collection will be from healthcare providers on the ground.

    Measured: Mar 2025 - Feb 2026

Timeline

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

  1. First posted31 Dec 2024
  2. Study start1 Mar 2025 (estimated)
  3. Primary completion28 Feb 2026 (estimated)
  4. Study completion28 Feb 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
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06753643
Sponsor's protocol ID
GERI1637
Acronym
IMPACTFrail
Status last verified
Dec 2024
First submitted
11 Dec 2024
Last updated
31 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The information will not be shared due to confidentiality.

Publications

  • O'Donovan MR, Sezgin D, Liew A, O'Caoimh R. Burden of disease, disability-adjusted life years and frailty prevalence. QJM. 2019 Apr 1;112(4):261-267. doi: 10.1093/qjmed/hcy291.

    PubMed 30541151
  • Milat A, Lee K, Conte K, Grunseit A, Wolfenden L, van Nassau F, Orr N, Sreeram P, Bauman A. Intervention Scalability Assessment Tool: A decision support tool for health policy makers and implementers. Health Res Policy Syst. 2020 Jan 3;18(1):1. doi: 10.1186/s12961-019-0494-2.

    PubMed 31900230
  • Stoyanov SR, Hides L, Kavanagh DJ, Wilson H. Development and Validation of the User Version of the Mobile Application Rating Scale (uMARS). JMIR Mhealth Uhealth. 2016 Jun 10;4(2):e72. doi: 10.2196/mhealth.5849.

    PubMed 27287964
  • Sutton E, Catling J, Segaert K, Veldhuijzen van Zanten J. Cognitive Health Worries, Reduced Physical Activity and Fewer Social Interactions Negatively Impact Psychological Wellbeing in Older Adults During the COVID-19 Pandemic. Front Psychol. 2022 Feb 17;13:823089. doi: 10.3389/fpsyg.2022.823089. eCollection 2022.

    PubMed 35250763
  • Lopez-Teros T, Gutierrez-Robledo LM, Perez-Zepeda MU. Gait Speed and Handgrip Strength as Predictors of Incident Disability in Mexican Older Adults. J Frailty Aging. 2014;3(2):109-12. doi: 10.14283/jfa.2014.10.

    PubMed 27049903
  • Tan WS, Nai ZL, Tan HTR, Nicholas S, Choo R, Ginting ML, Tan E, Teng PHJ, Lim WS, Wong CH, Ding YY; Geriatric Services Hub Programme Group. Protocol for a mixed-methods and multi-site assessment of the implementation process and outcomes of a new community-based frailty programme. BMC Geriatr. 2022 Jul 15;22(1):586. doi: 10.1186/s12877-022-03254-6.

    PubMed 35840898
  • Grigor'ev EG, Pankratova VA, Cherkashin AF. [Case of severe combined trauma]. Khirurgiia (Mosk). 1979 Oct;(10):109-10. No abstract available. Russian.

    PubMed 522389
  • Tulloch AJ, Moore V. A randomized controlled trial of geriatric screening and surveillance in general practice. J R Coll Gen Pract. 1979 Dec;29(209):733-40.

    PubMed 536982
  • Hyzy M, Bond R, Mulvenna M, Bai L, Dix A, Leigh S, Hunt S. System Usability Scale Benchmarking for Digital Health Apps: Meta-analysis. JMIR Mhealth Uhealth. 2022 Aug 18;10(8):e37290. doi: 10.2196/37290.

    PubMed 35980732
  • Kwan YH, Yoon S, Tan CS, Tai BC, Tan WB, Phang JK, Tan NC, Tan CYL, Quah YL, Koot D, Teo HH, Low LL. EMPOWERing Patients With Diabetes Using Profiling and Targeted Feedbacks Delivered Through Smartphone App and Wearable (EMPOWER): Protocol for a Randomized Controlled Trial on Effectiveness and Implementation. Front Public Health. 2022 Feb 25;10:805856. doi: 10.3389/fpubh.2022.805856. eCollection 2022.

    PubMed 35284389
  • Tay LB, Chua MP, Tay EL, Chan HN, Mah SM, Latib A, Wong CQ, Ng YS. Multidomain Geriatric Screen and Physical Fitness Assessment Identify Prefrailty/Frailty and Potentially Modifiable Risk Factors in Community-Dwelling Older Adults. Ann Acad Med Singap. 2019 Jun;48(6):171-180.

    PubMed 31377761
  • Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.

    PubMed 20957426
  • Powell BJ, Waltz TJ, Chinman MJ, Damschroder LJ, Smith JL, Matthieu MM, Proctor EK, Kirchner JE. A refined compilation of implementation strategies: results from the Expert Recommendations for Implementing Change (ERIC) project. Implement Sci. 2015 Feb 12;10:21. doi: 10.1186/s13012-015-0209-1.

    PubMed 25889199
  • Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci. 2009 Aug 7;4:50. doi: 10.1186/1748-5908-4-50.

    PubMed 19664226
  • Smith JD, Li DH, Rafferty MR. The Implementation Research Logic Model: a method for planning, executing, reporting, and synthesizing implementation projects. Implement Sci. 2020 Sep 25;15(1):84. doi: 10.1186/s13012-020-01041-8.

    PubMed 32988389

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy Ageing and Frailty, run by Geriatric Education and Research Institute.

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 7 inclusion and 3 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 31 Dec 2024. 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 Grace Sum, PhD ((+65) 6807 8020, sum.grace.ce@geri.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Qualitative study 1 (time frame: Mar 2025 - Feb 2026). The study lists 13 primary outcomes in all. 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 NCT06753643, which also lists 53 linked publications.

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 31 Dec 2024.

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