Healthy Taiwan Cultivation Plan: Building an Active-ageing Lifestyle in Rural Taiwan Through Integrating Novel Healthcare Technology - From Mitigating Digital and Health Literacy Gap, Establishing a Mobile Interactive Pro-active-ageing Information Platform, to Exploring Multi-dimensional Digital Biomarkers of Ageing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Activity-Sleep Pattern Regularity
研究概览
简要总结
Taiwan is entering a super-aged society in 2025, with more than 20% of the population aged 65 years or older. This rapid demographic shift, combined with increasing rates of chronic diseases, frailty, and dementia, has created growing challenges for healthcare and caregiving systems. Yunlin County, particularly its coastal region, has been one of Taiwan's earliest super-aged areas, showing higher rates of diabetes (10.5%), hypertension (28%), hyperlipidemia (26%), dementia (8%), and depression (12%) compared with national averages. Lifestyle factors such as tobacco (30%), betel nut (8%), and alcohol (15%) use are also more prevalent among local residents.
From 2022 to 2024, health screenings at CMU Beigang Hospital revealed a 36.1% abnormality rate among 12,222 visits, while another 5,965 assessments from the county's ICOPE program showed similarly high rates. Many older adults, particularly retired agricultural and fishing workers, experience sedentary lifestyles and polypharmacy-related risks, which worsen frailty, insomnia, depression, and cognitive decline. Low general and digital health literacy further limits their ability to adopt preventive behaviors, forming a vicious cycle between poor health and aging.
To address these challenges, the Ministry of Health and Welfare launched the "Healthy Taiwan Cultivation Plan." In alignment with this initiative, this project-led by CMU Beigang Hospital in collaboration with the National Health Research Institutes-aims to develop a wearable- and mobile-based health promotion model for rural older adults. The study will integrate research-grade actigraphy (Geneactiv), a mobile health platform ("iMED"), and the in-bed sensor iCue to monitor behavior, promote active aging, and enhance health and digital literacy. Ultimately, this project seeks to establish Taiwan's first integrated digital aging database and identify digital biomarkers for predicting cognitive and functional decline in older adults.
详细描述
This prospective observational cohort study aims to develop and assess a wearable and mobile health-based research framework to characterize health status, sleep, circadian rhythm, physical activity, digital literacy, and cognitive-related biomarkers among older adults living in rural Taiwan. The study focuses on Yunlin County, one of Taiwan's early super-aged regions, where chronic diseases, frailty, and dementia-related health needs are highly prevalent.
The study uses research-grade wearable and digital tools, including a GeneActiv actigraphy device, an AI-supported mobile health platform, and a smart in-bed sensor, to collect data on physical activity, sleep patterns, and related physiological parameters. The Aging Well Taiwan framework and the World Health Organization's Integrated Care for Older People framework will also be used to support standardized assessment of older adults' health status, health literacy, digital literacy, and functional needs.
Phase I, conducted from 2025 to 2026, will establish baseline data and assess the feasibility, usability, and acceptability of wearable and mobile health tools in community and outpatient settings. Participants will wear GeneActiv devices for at least two weeks, complete ICOPE assessments, and provide blood samples for dementia-related biomarkers, including total tau, phosphorylated tau 181, phosphorylated tau 217, amyloid beta 1-40, amyloid beta 1-42, neurofilament light chain, and apolipoprotein E genotyping. Validated questionnaires will be used to assess health literacy, digital literacy, lifestyle factors, and related clinical characteristics.
Phase II, conducted from 2027 to 2029, will extend the observational follow-up by integrating mobile health platform data with wearable and sensor-derived measures. Participants will be followed every three months to assess changes in activity, sleep, medication use, mental well-being, and behavioral outcomes. Quantitative data will be analyzed using GGIR and R software, while qualitative interviews will explore usability, user satisfaction, and experiences related to technology use.
This study will establish an integrated digital aging research database in Taiwan that combines wearable, behavioral, clinical, and biological data. Through collaboration with international partners such as the RADAR-AD consortium, the project aims to identify digital phenotypes and biomarkers associated with cognitive and functional decline. Ultimately, the study aims to inform a sustainable, evidence-based, and technology-supported model for promoting healthy aging and improving well-being among older adults in rural communities.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Currently living or receiving care in a stable environment for at least four weeks prior to enrollment:
- •For community-based participants: must have resided at the same address for ≥4 weeks.
- •For day-care participants: must have attended activities at the same dementia or elderly day-care center for ≥4 weeks.
- •Able and willing to participate in the study procedures.
- •Informed consent must be obtained before participation.
- •If the participant's cognitive function has declined to a level that prevents self-consent, written consent will be obtained from a legally authorized representative or primary caregiver.
排除标准
- •Unstable physical or psychological condition that makes participation unsafe, as determined by a clinical investigator - e.g., acute delirium or current respiratory infection (including COVID-19).
- •Any known allergy or skin sensitivity to the materials used in the Geneactiv actigraphy device or iCue sensor pad.
- •Any other medical, neurological, or behavioral condition deemed unsuitable for participation by the study physician.
研究组 & 干预措施
Health Promotion through Wearable and Mobile Technology
Participants will join a community-based health program integrating wearables, mobile health platforms, and structured education to promote active lifestyles, enhance health literacy, and collect longitudinal data in older adults in rural Taiwan.
Participants will:
- Wear a research-grade wrist actigraphy device (GeneActiv) to record activity, sleep, and light exposure for ≥2 weeks.
- Use the iMED mobile app (NHRI, Taiwan) for feedback, health education, and medication tracking.
- For participants with limited mobility, use an under-mattress iCue sensor to monitor respiration and movement.
- Attend Aging Well Taiwan sessions based on the WHO ICOPE framework.
- Provide baseline and follow-up blood samples for dementia-related biomarkers (Tau, Aβ, NfL) and APOE genotyping.
干预措施: Blood Biomarker Sampling (Biological)
Health Promotion through Wearable and Mobile Technology
Participants will join a community-based health program integrating wearables, mobile health platforms, and structured education to promote active lifestyles, enhance health literacy, and collect longitudinal data in older adults in rural Taiwan.
Participants will:
- Wear a research-grade wrist actigraphy device (GeneActiv) to record activity, sleep, and light exposure for ≥2 weeks.
- Use the iMED mobile app (NHRI, Taiwan) for feedback, health education, and medication tracking.
- For participants with limited mobility, use an under-mattress iCue sensor to monitor respiration and movement.
- Attend Aging Well Taiwan sessions based on the WHO ICOPE framework.
- Provide baseline and follow-up blood samples for dementia-related biomarkers (Tau, Aβ, NfL) and APOE genotyping.
干预措施: Geneactiv (Device)
Health Promotion through Wearable and Mobile Technology
Participants will join a community-based health program integrating wearables, mobile health platforms, and structured education to promote active lifestyles, enhance health literacy, and collect longitudinal data in older adults in rural Taiwan.
Participants will:
- Wear a research-grade wrist actigraphy device (GeneActiv) to record activity, sleep, and light exposure for ≥2 weeks.
- Use the iMED mobile app (NHRI, Taiwan) for feedback, health education, and medication tracking.
- For participants with limited mobility, use an under-mattress iCue sensor to monitor respiration and movement.
- Attend Aging Well Taiwan sessions based on the WHO ICOPE framework.
- Provide baseline and follow-up blood samples for dementia-related biomarkers (Tau, Aβ, NfL) and APOE genotyping.
干预措施: iMED Mobile Health Platform (Behavioral)
Health Promotion through Wearable and Mobile Technology
Participants will join a community-based health program integrating wearables, mobile health platforms, and structured education to promote active lifestyles, enhance health literacy, and collect longitudinal data in older adults in rural Taiwan.
Participants will:
- Wear a research-grade wrist actigraphy device (GeneActiv) to record activity, sleep, and light exposure for ≥2 weeks.
- Use the iMED mobile app (NHRI, Taiwan) for feedback, health education, and medication tracking.
- For participants with limited mobility, use an under-mattress iCue sensor to monitor respiration and movement.
- Attend Aging Well Taiwan sessions based on the WHO ICOPE framework.
- Provide baseline and follow-up blood samples for dementia-related biomarkers (Tau, Aβ, NfL) and APOE genotyping.
干预措施: iCue (Device)
Health Promotion through Wearable and Mobile Technology
Participants will join a community-based health program integrating wearables, mobile health platforms, and structured education to promote active lifestyles, enhance health literacy, and collect longitudinal data in older adults in rural Taiwan.
Participants will:
- Wear a research-grade wrist actigraphy device (GeneActiv) to record activity, sleep, and light exposure for ≥2 weeks.
- Use the iMED mobile app (NHRI, Taiwan) for feedback, health education, and medication tracking.
- For participants with limited mobility, use an under-mattress iCue sensor to monitor respiration and movement.
- Attend Aging Well Taiwan sessions based on the WHO ICOPE framework.
- Provide baseline and follow-up blood samples for dementia-related biomarkers (Tau, Aβ, NfL) and APOE genotyping.
干预措施: Aging Well Taiwan (Behavioral)
结局指标
主要结局
Activity-Sleep Pattern Regularity
时间窗: Baseline to 36 months.
Mean daily activity counts, sleep-wake cycles, and circadian rhythm stability will be assessed using Geneactiv and iCue in-bed sensors. Variables include total activity counts, sleep duration, sleep efficiency, wake after sleep onset (WASO), daytime napping, light exposure amount and timing, M5/L5 (five hours of highest/lowest activity), mean sleep midpoint (MSA), intra-daily variability (IV), inter-daily stability (IS), and Sleep Regularity Index (SRI). Data will be analyzed using the open-source GGIR algorithm and R software to evaluate individual day-night rhythm stability and longitudinal changes.
Integrated Care for Older People (ICOPE) Function Assessment
时间窗: Baseline to 36 months.
As assessed using the WHO Integrated Care for Older People (ICOPE) screening tool, covering six domains: cognition, mobility, nutrition, vision, hearing, and mood. Scores are classified as "declined" or "maintained" function for each domain. Higher functional integrity across domains indicates better overall health status.
Biomarkers for Cognitive and Functional Decline
时间窗: Two time points - baseline (before intervention) and end of study (month 36).
Venous blood samples (10 mL) will be collected to measure total Tau, phosphorylated Tau 181 (pT181), phosphorylated Tau 217 (pT217), amyloid beta 1-40 (Aβ40), amyloid beta 1-42 (Aβ42), and neurofilament light chain (NfL) using validated immunoassays. APOE genotyping will be performed once at baseline. These blood-based biomarkers will be correlated with digital device-derived metrics (SRI, IS, IV) and cognitive outcomes to explore their potential as predictors of cognitive decline.
Qualitative Evaluation of Feasibility and User Experience
时间窗: Baseline to 36 months (post-intervention qualitative evaluation).
Semi-structured interviews and focus groups will be conducted with participants and caregivers to explore usability, satisfaction, and perceived benefits of the Geneactiv wearable, iCue in-bed sensor, and iMED mobile platform. Interview data will be analyzed thematically to identify facilitators, barriers, and behavioral impacts related to long-term use.
Activity-Sleep Pattern Regularity
时间窗: Baseline to 36 months.
Mean daily activity counts, sleep-wake cycles, and circadian rhythm stability will be assessed using Geneactiv and iCue in-bed sensors. Variables include total activity counts, sleep duration, sleep efficiency, wake after sleep onset (WASO), daytime napping, light exposure amount and timing, M5/L5 (five hours of highest/lowest activity), mean sleep midpoint (MSA), intra-daily variability (IV), inter-daily stability (IS), and Sleep Regularity Index (SRI). Data will be analyzed using the open-source GGIR algorithm and R software to evaluate individual day-night rhythm stability and longitudinal changes.
Integrated Care for Older People (ICOPE) Function Assessment
时间窗: Baseline to 36 months.
As assessed using the WHO Integrated Care for Older People (ICOPE) screening tool, covering six domains: cognition, mobility, nutrition, vision, hearing, and mood. Scores are classified as "declined" or "maintained" function for each domain. Higher functional integrity across domains indicates better overall health status.
Biomarkers for Cognitive and Functional Decline
时间窗: Two time points - baseline (before intervention) and end of study (month 36).
Venous blood samples (10 mL) will be collected to measure phosphorylated Tau 217 (pT217) and Neurofilament Light Chain (NfL) concentrations using validated immunoassays. These blood-based biomarkers will be correlated with digital device data (SRI, IS, IV) and cognitive outcomes to explore their potential as predictors of decline.
Qualitative Evaluation of Feasibility and User Experience
时间窗: Baseline to 36 months (post-intervention qualitative evaluation).
Semi-structured interviews and focus groups will be conducted with participants and caregivers to explore usability, satisfaction, and perceived benefits of the Geneactiv wearable, iCue in-bed sensor, and iMED mobile platform. Interview data will be analyzed thematically to identify facilitators, barriers, and behavioral impacts related to long-term use.
次要结局
未报告次要终点
研究者
Ta-wei Guu
Consultant Psychiatrist
China Medical University Hospital