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| Name | Class |
|---|---|
| Ministry of Health and Welfare, Taiwan | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Geneactiv | Device | Participants will wear a research-grade actigraphy device (Geneactiv original, developed by Activinsights UK) on the non-dominant wrist for at least two consecutive weeks to continuously record physical activity, sleep-wake patterns, and light exposure. The visualised results will be presented to the participants to motivate their behavioural change. |
| Measure | Description | Time Frame |
|---|---|---|
| Activity-Sleep Pattern Regularity | 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. | Baseline to 36 months. |
| Integrated Care for Older People (ICOPE) Function Assessment | 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. | Baseline to 36 months. |
| Biomarkers for Cognitive and Functional Decline | 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. | Two time points - baseline (before intervention) and end of study (month 36). |
| Qualitative Evaluation of Feasibility and User Experience | 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. |
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Inclusion Criteria:
Currently living or receiving care in a stable environment for at least four weeks prior to enrollment:
Able and willing to participate in the study procedures.
Informed consent must be obtained before participation.
Exclusion Criteria:
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The study population includes community-dwelling and outpatient older adults who are recruited through clinical services, community outreach, and research-related activities at China Medical University Beigang Hospital. Eligible participants are older adults who are willing to participate in the study and able to complete clinical assessments, cognitive evaluation, blood sample collection, and wearable device monitoring.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr Ta-Wei Guu Consultant psychiatrist, MD, PhD | Contact | +886-57837901 | 066753@tool.caaumed.org.tw | |
| Yueh-Heng Chiang, RN, MS. | Contact | isyuehheng@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China Medical University Beigang Hospital | Recruiting | London | Alabama | WC1N 2AN | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37236695 | Result | Guu TW, Muurling M, Khan Z, Kalafatis C, Aarsland D, Ffytche D, Brem AK. Wearable devices: underrepresentation in the ageing society. Lancet Digit Health. 2023 Jun;5(6):e336-e337. doi: 10.1016/S2589-7500(23)00069-9. No abstract available. | |
| 38497216 | Result | Guu TW, Brem AK, Albertyn CP, Kandangwa P, Aarsland D, Ffytche D. Wrist-worn actigraphy in agitated late-stage dementia patients: A feasibility study on digital inclusion. Alzheimers Dement. 2024 May;20(5):3211-3218. doi: 10.1002/alz.13772. Epub 2024 Mar 18. |
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We will decide if the IPD can be shared before the end of the study.
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Peripheral blood samples will be collected and processed for blood-based biomarker analyses. Retained biospecimens may include whole blood, plasma, serum, and/or buffy coat for assessment of neurodegenerative and Alzheimer's disease-related biomarkers, including total tau, phosphorylated tau, amyloid-beta, neurofilament light chain, and APOE genotyping where applicable.
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| iMED Mobile Health Platform | Behavioral | Participants will use the "iMED" mobile application developed by the National Health Research Institutes in Taiwan (https://www.nhri.imed-health.com/). The platform provides personalized health education, medication reminders, AI-driven feedback on wearable data, and links to Taiwan's National Health Insurance health records. |
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| iCue | Device | A non-invasive smart mat (iCue) placed under the mattress continuously monitors respiration rate, movement, and sleep parameters in participants with limited mobility. |
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| Aging Well Taiwan | Behavioral | Participants will attend a community-based educational course adapted from Singapore's "Aging Well" framework, covering physical activity, diet, cognitive health, and digital literacy. The program follows the WHO Integrated Care for Older People (ICOPE) model and supports active aging and social participation. |
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| Blood Biomarker Sampling | Biological | Participants will provide venous blood samples at baseline and follow-up visits for analysis of dementia-related biomarkers, including 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), as well as apolipoprotein E (APOE) genotyping. |
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| Baseline to 36 months (post-intervention qualitative evaluation). |