Digital Technology for Active and Healthy Ageing in Taiwan
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorChina Medical University Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Geneactiv
DeviceParticipants 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.
iMED Mobile Health Platform
BehavioralParticipants 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.
iCue
DeviceA non-invasive smart mat (iCue) placed under the mattress continuously monitors respiration rate, movement, and sleep parameters in participants with limited mobility.
Aging Well Taiwan
BehavioralParticipants 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.
Blood Biomarker Sampling
Biological/VaccineParticipants 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.
Treatment groups
140 Participants
are divided into 1 treatment groupGroup A: Health Promotion through Wearable and Mobile Technology5 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline to 36 months.2
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.
Time frame
Baseline to 36 months.3
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.
Time frame
Two time points - baseline (before intervention) and end of study (month 36).4
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.
Time frame
Baseline to 36 months (post-intervention qualitative evaluation).Sponsors and contacts
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China Medical University Hospital
Lead sponsor
Ministry of Health and Welfare, Taiwan
Collaborator
Source ClinicalTrials.gov