NCT07232667|Not Yet Recruiting

Digital Technology for Active and Healthy Ageing in Taiwan

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

China Medical University Hospital ClinicalTrials.gov

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1 other identifier

CMUH114-REC3-134

Study Type

interventional

Target

140

Locations

1 country

Sites

Timeline

RegisteredNov 2025

StartedMar 2026

CompletionDec 2029

Brief Summary

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

140

participants targeted

Target at P50-P75 for not_applicable

Timeline

45mo left

Started Mar 2026

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.8 years study duration

Study Progress5%

Mar 2026Dec 2029

First Submitted

Initial submission to the registry

November 14, 2025

Completed

4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2025

Completed

3 months until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed

2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

2.8 years

First QC Date

November 14, 2025

Last Update Submit

February 9, 2026

Conditions

Healthy Aging Digital Health Literacy

Keywords

Elderly peopleWearable technologyDigital health literacyHealthy agingHealth literacyDigital gapDigital biomarkers

Outcome Measures

Primary Outcomes (4)

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.
Baseline to 36 months (post-intervention qualitative evaluation).

Study Arms (1)

Health Promotion through Wearable and Mobile Technology

EXPERIMENTAL

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.

Device: GeneactivBehavioral: iMED Mobile Health PlatformDevice: iCueBehavioral: Aging Well TaiwanBiological: Blood Biomarker Sampling

Interventions

GeneactivDEVICE

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.