Optimizing INtrinsic Capacity for Functional INdependence and to Impede FrailTY in Older Adults: Adaptation of the WHO-ICOPE for Healthy Ageing in Singapore
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Life space mobility
研究概览
简要总结
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).
详细描述
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:
- Phase 1 (Proof-of-Concept) - 12 months. This preparatory phase focuses on 3 key areas: technology readiness, care pathway development, and stakeholder readiness assessment.
- 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.
- 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.
- 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.
- 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.
- 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.
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. 4. 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(in Phases 1, 2 and 3):
- •Any Singaporean or Permanent Resident (PR) aged 60 years and above
- •Able to provide informed consent (or legally acceptable representative available)
排除标准
- •(in Phases 1, 2 and 3):
- •Non-Singaporeans or non-PRs under 60 years of age
- •Residents of sheltered or nursing homes
研究组 & 干预措施
Intervention with further assessment and clinical referrals based on needs identified
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.
干预措施: INFINITY-ICOPE programme (Other)
Wait-listed control
Participants will continue usual care at active ageing centres and receive the same interventions after their 12-month assessment.
干预措施: INFINITY-ICOPE programme (Other)
结局指标
主要结局
Life space mobility
时间窗: 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.
Community implementation outcomes of INFINITY-ICOPE programme
时间窗: 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.
次要结局
- 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.)
研究者
Tay Bee Gek Laura
Senior Consultant
Sengkang General Hospital