Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 2:15 AM
Study NCT ID:
NCT07477561
Status:
RECRUITING
Last Update Posted:
2026-03-17
First Post:
2026-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimizing INtrinsic Capacity for Functional INdependence and to Impede FrailTY in Older Adults: Adaptation of the WHO-ICOPE for Healthy Ageing in Singapore
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Participants in wait-listed control centre will cross over to active intervention after 12 months.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-12', 'studyFirstSubmitDate': '2026-03-01', 'studyFirstSubmitQcDate': '2026-03-12', 'lastUpdatePostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Life space mobility', 'timeFrame': 'From enrollment to the end of intervention at 12 months.', 'description': "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."}, {'measure': 'Community implementation outcomes of INFINITY-ICOPE programme', 'timeFrame': '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).', 'description': "Fidelity: Measured by adherence rates (%) to protocol specifications and intervention delivery as intended, assessed through structured fidelity checklists completed by implementation staff.\n\nPenetration: Measured as the proportion (%) of eligible older adults reached and enrolled from target community settings, based on programme enrollment records.\n\nSustainability: 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.\n\nFollow-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."}], 'secondaryOutcomes': [{'measure': 'Adherence to automated frailty screening and remote intrinsic capacity monitoring', 'timeFrame': 'Assessed at baseline, 6, 12, and 24 months.', 'description': 'Proportion of participants who complete regular screening assessments using SCREENii technology and engage with remote monitoring through the ENGAGE app, measured by frequency of use, completion rates, and sustained engagement over time.'}, {'measure': 'Prevention of frailty progression and preservation of intrinsic capacity', 'timeFrame': 'Assessed at baseline, 6, 12, and 24 months.', 'description': 'Changes in frailty status and intrinsic capacity status across the 6 domains (mobility, cognition, mental health, hearing, vision, nutrition) following tiered screening and early intervention.\n\nFrailty status will be measured using the Fried Frailty Phenotype, reported as the proportion (%) of participants classified as frail, pre-frail, or robust.\n\nIntrinsic capacity will be evaluated using the ICOPE Step 1 screening followed by Step 2 clarification assessments for each domain:\n\nMobility: Short Physical Performance Battery (SPPB) score (range 0-12) Cognition: Chinese Mini Mental State Examination (CMMSE) score and a single self-reported memory concern question (presence or absence) Mental health: Geriatric Depression Scale-15 (GDS-15) score Hearing: Screening audiometer results (threshold levels in decibels) Vision: Visual acuity test results using handheld Snellen chart Nutrition: Mini Nutritional Assessment Short Form (MNA-SF) score'}, {'measure': 'Health-related quality of life improvement', 'timeFrame': 'Assessed at baseline, 6, 12, and 24 months.', 'description': "Changes in validated quality of life measures using EuroQol 5-dimension (EQ-5D-5L) and EuroQol Visual Analogue Scale (EQ-VAS) following INFINITY-ICOPE intervention.\n\nFor EQ-5D-5L, participants indicate their health by selecting one level in each of five dimensions (mobility, self-care, usual activities, pain / discomfort, anxiety / depression), producing a 5-digit code representing their health state.\n\nThe EQ-VAS records self-rated health on a 0-100 scale, with endpoints labeled 'best' and 'worst' imaginable health, providing a quantitative measure of perceived health."}, {'measure': 'Healthcare service utilization', 'timeFrame': 'Assessed at baseline, 6, 12, and 24 months.', 'description': 'Healthcare service utilization will be assessed by the number of emergency department (ED) visits and hospitalizations occurring within the past 6 months or 1 year, depending on the timing of the study visit. The reasons for each ED visit and hospitalization will also be recorded. These measures will be compared between the intervention and control groups.'}, {'measure': 'Association between oral frailty and physical frailty for risk stratification', 'timeFrame': 'Assessed at baseline, 6, 12, and 24 months.', 'description': 'Oral frailty will be assessed using the Oral Frailty Index-8 (OFI-8), which provides a score indicating the degree of oral frailty. The higher the OFI-8 score, the higher the risk of frailty, i.e., 0-2 points indicates low risk; 3 points indicates moderate risk; and greater than 4 points indicates high risk. Physical frailty will be measured using the Fried Frailty Phenotype, categorizing participants as frail, pre-frail, or robust based on established criteria.\n\nThe outcome will be the correlation between the OFI-8 score and physical frailty status, analyzed to identify relationships that may improve risk stratification and guide targeted interventions within the INFINITY-ICOPE framework.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Frailty', 'Intrinsic capacity decline', 'Community-dwelling older adults', 'Age-related functional decline', 'Healthy ageing', 'Early identification and management of frailty and functional decline'], 'conditions': ['Frailty in Older Adults', 'Intrinsic Capacity', 'Age-related Functional Decline', 'Healthy Ageing']}, 'descriptionModule': {'briefSummary': '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:\n\n* 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?\n* Will at least 80% of screened older adults adhere to recommended care pathways and interventions?\n* 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.\n\nParticipants will:\n\n* 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.\n* Undergo comprehensive screening assessments including mobility, cognition, mental health, hearing, vision, and nutritional status.\n* Receive 2 follow-up phone calls at 3-month and 9-month intervals to monitor progress.\n* 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.\n* If in the wait-list control group: receive the same interventions after their 3rd study visit (12 months later).', 'detailedDescription': "The INFINITY-ICOPE programme integrates the concepts of frailty and intrinsic capacity - a person's physical and mental abilities essential for maintaining overall health and well-being. Since intrinsic capacity represents the physiological reserves whose decline can lead to frailty, monitoring intrinsic capacity trajectories enables timely intervention to address deteriorating physical and mental capacities. The programmme employs a tiered approach to provide comprehensive geriatric assessment for frail older adults, utilizing technology-enabled tools including the SCREENii algorithmic approach for objective physical frailty assessment and the ENGAGE app to empower older individuals through self-screening, remote intrinsic capacity monitoring, and behavioural nudges.\n\nThe investigators primary aim is maintaining older adults' independence and community engagement, measured through life-space mobility. Secondary aims encompass promoting regular screening for frailty and intrinsic capacity decline, implementing early intervention strategies, enhancing quality of life, and developing a cost-effective healthcare delivery model. INFINITY-ICOPE follows the implementation research logic model to ensure rigorous and replicable research. The study comprises 4 phases:\n\n1. Phase 1 (Proof-of-Concept) - 12 months. This preparatory phase focuses on 3 key areas: technology readiness, care pathway development, and stakeholder readiness assessment.\n\n * Technology development: The SCREENii platform will be enhanced to provide automated frailty screening through grip strength and gait speed measurements. The ENGAGE app will incorporate WHO-ICOPE Step 1 screening and deliver personalized care plans adapted for local needs.\n * Care pathway development: Personalized pathways will be developed for frailty management through regional hospital networks and intrinsic capacity domain-specific interventions based on WHO-ICOPE guidelines. Community assessors will receive training in Step 1 screening and individualized care planning, with 400 older adults recruited to test feasibility and assess intrinsic capacity decline prevalence.\n * Readiness assessment: Surveys and focus group discussions will evaluate attitudes and expectations of multidisciplinary care providers (eldercare staff, community nurses, family physicians, social workers) towards INFINITY-ICOPE implementation. Additional focus groups with 30 trained community assessors will capture their screening experiences. Usability testing with 15 older adults will assess SCREENii completion times and ENGAGE app quality using the mobile app rating scale. This phase will inform resource planning for Phase 2 and refine implementation strategies based on identified barriers and enablers.\n2. Phase 2 (Proof-of-Value) - 12 months. This single-arm pre-post pilot study will evaluate INFINITY-ICOPE's potential impact by recruiting 60 older adults (aged 60 and above) from an existing mobile frailty screening platform, termed Individual Physical Performance Test for Seniors (IPPT-S). The multi-domain geriatric screening and comprehensive fitness battery will validate SCREENii plus ICOPE Step 1 for stratifying participants by frailty and intrinsic capacity decline.\n3. Phase 3 (Testing-bed) - 30 months. This study employs a pragmatic controlled design with 540 older adults across 8 eldercare and/or active ageing centres within SingHealth zones. Intervention design: The INFINITY-ICOPE programme includes integrated frailty and intrinsic capacity screening, targeted referrals based on stratification, and 6-monthly self-monitoring via ENGAGE app and SCREENii. Participants are stratified into 3 groups post-screening: (a) Frail (regardless of intrinsic capacity status); (b) Non-frail with declining intrinsic capacity; and (c) Non-frail with intact intrinsic capacity.\n\n Targeted interventions: Frail participants (Fried score of 3 and above) receive comprehensive geriatric assessment at geriatric specialty hubs, whilst non-frail participants with intrinsic capacity decline undergo Steps 2 to 3 assessments at Community Health Posts with personalized interventions. All intervention participants receive ENGAGE app notifications including appointment reminders, lifestyle nudges, and screening prompts. Additional cognitive assessment via Cognify (30-minute automated battery) validated cognitive screening for enhanced stratification. Control group: Continues usual activities with wait-list access to INFINITYICOPE after 12-month outcomes assessment, enabling centres to scale the programme as standard care. Data collection: Comprehensive measures collected at 6-monthly intervals include socio-demographics, frailty / sarcopenia / intrinsic capacity status, medical comorbidities, functional performance, cognitive / mood assessments, quality of life, and intervention adherence, emphasizing both clinical and implementation effectiveness for sustainability evaluation.\n4. Phase 4 (Scale-up) - 6 months. This phase focuses on programme evaluation and scaling preparation without recruiting new participants. Activities centre on completing Phase 3 follow-ups, comprehensive data analysis, and sustainability assessment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: (in Phases 1, 2 and 3):\n\n* Any Singaporean or Permanent Resident (PR) aged 60 years and above\n* Able to provide informed consent (or legally acceptable representative available)\n\nExclusion Criteria (in Phases 1, 2 and 3):\n\n* Non-Singaporeans or non-PRs under 60 years of age\n* Residents of sheltered or nursing homes'}, 'identificationModule': {'nctId': 'NCT07477561', 'acronym': 'INFINITY-ICOPE', 'briefTitle': 'Optimizing INtrinsic Capacity for Functional INdependence and to Impede FrailTY in Older Adults: Adaptation of the WHO-ICOPE for Healthy Ageing in Singapore', 'organization': {'class': 'OTHER', 'fullName': 'Sengkang General Hospital'}, 'officialTitle': 'Optimizing INtrinsic Capacity for Functional INdependence and to Impede FrailTY in Older Adults: Adaptation of the WHO-ICOPE for Healthy Ageing in Singapore', 'orgStudyIdInfo': {'id': '2023-2058'}, 'secondaryIdInfos': [{'id': 'MOH-001201', 'type': 'OTHER_GRANT', 'domain': 'National Medical Research Council'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention with further assessment and clinical referrals based on needs identified', 'description': '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.', 'interventionNames': ['Other: INFINITY-ICOPE programme']}, {'type': 'OTHER', 'label': 'Wait-listed control', 'description': 'Participants will continue usual care at active ageing centres and receive the same interventions after their 12-month assessment.', 'interventionNames': ['Other: INFINITY-ICOPE programme']}], 'interventions': [{'name': 'INFINITY-ICOPE programme', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Intervention with further assessment and clinical referrals based on needs identified', 'Wait-listed control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'facility': 'Sengkang General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Denise Qian Ling Chua', 'role': 'CONTACT', 'email': 'infinity.icope@singhealth.com.sg', 'phone': '6580927146'}], 'overallOfficials': [{'name': 'Laura Bee Gek Tay', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sengkang General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'IPD sharing with other researchers is not planned at this time. The research team will evaluate potential data sharing opportunities following study completion, subject to ethical approval, participant consent provisions, and establishment of secure data sharing protocols that maintain participant confidentiality.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sengkang General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Singapore Health Services', 'class': 'OTHER'}, {'name': 'Singapore General Hospital', 'class': 'OTHER'}, {'name': 'Changi General Hospital', 'class': 'OTHER'}, {'name': 'SingHealth Polyclinics', 'class': 'OTHER'}, {'name': 'National Dental Centre, Singapore', 'class': 'OTHER'}, {'name': 'Geriatric Education and Research Institute', 'class': 'OTHER_GOV'}, {'name': 'National University of Singapore', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Consultant', 'investigatorFullName': 'Tay Bee Gek Laura', 'investigatorAffiliation': 'Sengkang General Hospital'}}}}