Sengkang General Hospital
Singapore
Location status: Recruiting
NCT Number: NCT07477561
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).
Interested in participating?
Request Info60 year and older
All sexes
Interventional
Not applicable
Singapore
Location status: Recruiting
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.
The 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:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(in Phases 1, 2 and 3):
Exclusion criteria
(in Phases 1, 2 and 3):
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.
Time frame: From enrollment to the end of intervention at 12 months.
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.
Time frame: 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).
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.
Time frame: Assessed at baseline, 6, 12, and 24 months.
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.
Time frame: Assessed at baseline, 6, 12, and 24 months.
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.
Frailty status will be measured using the Fried Frailty Phenotype, reported as the proportion (%) of participants classified as frail, pre-frail, or robust.
Intrinsic capacity will be evaluated using the ICOPE Step 1 screening followed by Step 2 clarification assessments for each domain:
Mobility: 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
Time frame: Assessed at baseline, 6, 12, and 24 months.
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.
For 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.
The 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.
Time frame: Assessed at baseline, 6, 12, and 24 months.
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.
Time frame: Assessed at baseline, 6, 12, and 24 months.
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.
The 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.
Contact information is provided by the study sponsor or research team.
Sengkang General Hospital
Other
Acronym: INFINITY-ICOPE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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