Trials / Not Yet Recruiting
Not Yet RecruitingNCT07232667
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
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- Sponsor
- China Medical University Hospital · Academic / Other
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Accepted
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.
Detailed description
This single-arm interventional study aims to develop a wearable and mobile health-based model to improve health and digital literacy among older adults living in rural Taiwan. The study focuses on Yunlin County, one of Taiwan's earliest super-aged regions, where chronic diseases, frailty, and dementia are highly prevalent. The project combines community-based interventions with continuous monitoring using wearable and digital tools to promote active aging and reduce health disparities. The intervention integrates a research-grade wearable actigraphy device (Geneactiv), an AI-supported mobile health platform (iMED), and a smart in-bed sensor (iCue). These tools will continuously monitor physical activity, sleep patterns, and physiological parameters, while also providing real-time feedback and personalized health education. In addition, the "Aging Well Taiwan" program and the World Health Organization's Integrated Care for Older People (ICOPE) framework will be used to strengthen both health literacy and digital literacy among participants. Phase I (2025-2026): The first phase will establish baseline data and evaluate the feasibility, usability, and acceptability of wearable and mobile tools in community 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 (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. Validated questionnaires will be used to assess health literacy, digital literacy, and lifestyle factors. Phase II (2027-2029): The second phase will implement a single-arm intervention integrating the mobile health platform with wearable and sensor data. Participants will be followed up every three months to track changes in activity, sleep, medication use, mental well-being, and behavioral outcomes. Quantitative data will be analyzed using GGIR, R, and SPSS software, while qualitative interviews will explore usability, user satisfaction, and behavioral changes related to technology use. This study will establish Taiwan's first integrated digital aging database that merges wearable, behavioral, 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 establish a sustainable, evidence-based, and technology-supported model that promotes healthy aging and improves well-being among older adults in rural communities.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Geneactiv | 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. |
| BEHAVIORAL | iMED Mobile Health Platform | 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. |
| DEVICE | iCue | A non-invasive smart mat (iCue) placed under the mattress continuously monitors respiration rate, movement, and sleep parameters in participants with limited mobility. |
| BEHAVIORAL | Aging Well Taiwan | 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. |
| BIOLOGICAL | Blood Biomarker Sampling | 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. |
Timeline
- Start date
- 2026-03-01
- Primary completion
- 2028-12-31
- Completion
- 2029-12-31
- First posted
- 2025-11-18
- Last updated
- 2026-02-11
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT07232667. Inclusion in this directory is not an endorsement.