Digital Technology for Active and Healthy Ageing in Taiwan

China Medical University

Status: Enrolling

Conditions: Digital Health Literacy; Healthy Aging

Treatments: Device: iCue; Behavioral: iMED Mobile Health Platform; Biological: Blood Biomarker Sampling; Behavioral: Aging Well Taiwan; Device: Geneactiv

Study type: Observational

Funder types: Other

Identifiers

NCT07232667

CMUH114-REC3-134

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 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.

2. Able and willing to participate in the study procedures.

3. 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.

Exclusion criteria

1. 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).
2. Any known allergy or skin sensitivity to the materials used in the Geneactiv actigraphy device or iCue sensor pad.
3. Any other medical, neurological, or behavioral condition deemed unsuitable for participation by the study physician.

Trial design

140 participants in 1 patient group

Health Promotion through Wearable and Mobile Technology

Description:

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: 1. Wear a research-grade wrist actigraphy device (GeneActiv) to record activity, sleep, and light exposure for ≥2 weeks. 2. Use the iMED mobile app (NHRI, Taiwan) for feedback, health education, and medication tracking. 3. For participants with limited mobility, use an under-mattress iCue sensor to monitor respiration and movement. 4. Attend Aging Well Taiwan sessions based on the WHO ICOPE framework. 5. Provide baseline and follow-up blood samples for dementia-related biomarkers (Tau, Aβ, NfL) and APOE genotyping.

Treatment:

Device: Geneactiv

Biological: Blood Biomarker Sampling

Behavioral: Aging Well Taiwan

Behavioral: iMED Mobile Health Platform

Device: iCue