Healthy AgingNCT07232667
Digital Technology for Active and Healthy Ageing in Taiwan
An observational study of Healthy Aging and Digital Health Literacy, run by China Medical University Hospital at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging, Digital Health Literacy
- What is being tested?
- Geneactiv, iMED Mobile Health Platform and iCue
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 140 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Apr 2026to 31 Dec 2029
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
- Able and willing to participate in the study procedures.
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yueh-Heng Chiang, RN, MS. contact
United Kingdom1 site, 1 recruiting
- Recruiting
China Medical University Beigang Hospital
London, Alabama, WC1N 2AN
Ta-Wei Guu, MD, PhD, +886-57837901, da20vid@gmail.com
Yueh-Heng Chiang, RN, MS, +886-57837901, isyuehheng@gmail.com
About this study
Official title: 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
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.
Read the detailed 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.
- Conditions
- Healthy Aging, Digital Health Literacy
- Being tested
- Geneactiv, iMED Mobile Health Platform, iCue, Aging Well Taiwan, Blood Biomarker Sampling
- Keywords
- Elderly people, Wearable technology, Digital health literacy, Healthy aging, Health literacy, Digital gap, Digital biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
iMED Mobile Health PlatformBehavioural
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.
iCueDevice
A non-invasive smart mat (iCue) placed under the mattress continuously monitors respiration rate, movement, and sleep parameters in participants with limited mobility.
Aging Well TaiwanBehavioural
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.
Blood Biomarker SamplingBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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:
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. Receives: Device: Geneactiv; Behavioral: iMED Mobile Health Platform; Device: iCue; Behavioral: Aging Well Taiwan; Biological: Blood Biomarker Sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 36 months (post-intervention qualitative evaluation).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start22 Apr 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Responsible party
- Principal investigator, Ta-wei Guu, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07232667
- Sponsor's protocol ID
- CMUH114-REC3-134
- Status last verified
- May 2026
- First submitted
- 14 Nov 2025
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will decide if the IPD can be shared before the end of the study.
Publications
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.
PubMed 37236695Guu 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.
PubMed 38497216
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07232667
- Acronym / sponsor ID
- CMUH114-REC3-134
- Conditions
- Healthy Aging, Digital Health Literacy
- Keywords
- Elderly people, Wearable technology, Digital health literacy, Healthy aging, Health literacy, Digital gap, Digital biomarkers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health and Welfare, Taiwan
- Study start
- 22 Apr 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health Promotion through Wearable and Mobile Technology | – | Device: Geneactiv, Behavioral: iMED Mobile Health Platform, Device: iCue, Behavioral: Aging Well Taiwan, Biological: Blood Biomarker SamplingParticipants 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GeneactivParticipants 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. | Device | Health Promotion through Wearable and Mobile Technology |
| iMED Mobile Health PlatformParticipants 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. | Behavioural | Health Promotion through Wearable and Mobile Technology |
| iCueA non-invasive smart mat (iCue) placed under the mattress continuously monitors respiration rate, movement, and sleep parameters in participants with limited mobility. | Device | Health Promotion through Wearable and Mobile Technology |
| Aging Well TaiwanParticipants 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. | Behavioural | Health Promotion through Wearable and Mobile Technology |
| Blood Biomarker SamplingParticipants 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. | Biological | Health Promotion through Wearable and Mobile Technology |
Primary outcome
Activity-Sleep Pattern Regularity
Time frame: Baseline to 36 months.
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.
Integrated Care for Older People (ICOPE) Function Assessment
Time frame: Baseline to 36 months.
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.
Biomarkers for Cognitive and Functional Decline
Time frame: Two time points - baseline (before intervention) and end of study (month 36).
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.
Qualitative Evaluation of Feasibility and User Experience
Time frame: Baseline to 36 months (post-intervention qualitative evaluation).
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Results publication: PubMed 37236695Guu 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.
- Results publication: PubMed 38497216Guu 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.
- Individual participant dataSharing planned: Undecided. We will decide if the IPD can be shared before the end of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yueh-Heng Chiang, RN, MS. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Aging and Digital Health Literacy, run by China Medical University Hospital at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Ta-Wei Guu Consultant psychiatrist, MD, PhD (+886-57837901, 066753@tool.caaumed.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activity-Sleep Pattern Regularity (time frame: Baseline to 36 months.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07232667, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.