Wearable tools to support dementia care in rural Taiwan
Facilitating the Measurement and Treatment of the Behavioral Symptoms of Dementia (BPSD) and Understanding Caregiver Burden Using Wearable Devices in Rural Taiwan - A Dyadic Feasibility Pilot Study
This project will test whether a wrist activity tracker and light-therapy glasses are easy to use and can help people with Alzheimer's dementia and their family caregivers in rural Taiwan.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Sex | All |
| Sponsor | China Medical University Hospital Academic / other |
| Locations | 1 site (Beigang, Yunlin) |
| Trial ID | NCT07249918 on ClinicalTrials.gov |
What this trial studies
Researchers will give people with probable Alzheimer's disease (and their caregivers when appropriate) a GeneActiv wrist activity tracker to record continuous activity and sleep and Re-Timer light-therapy glasses to use for morning light exposure. The team will measure how willing participants are to wear the devices, how easy the devices are to use, and whether light therapy changes sleep patterns or caregiver stress over several weeks. Device-collected measures (for example sleep regularity) will be compared with standard caregiver questionnaires to see how well continuous data match reported symptoms. Findings will be used to plan larger studies and to explore whether wearable tools can be integrated into dementia care in aging rural communities.
Who should consider this trial
Good fit: Adults with probable Alzheimer's disease or MCI due to AD who have at least one prominent behavioral or psychological symptom (such as agitation, apathy, depression, or nighttime sleep disturbance), a stable living situation, and the ability to consent or a legally authorized representative to consent.
Not a fit: People without prominent BPSD, with unstable living arrangements, with severe visual or wrist impairment that prevents wearing the devices, or who cannot tolerate the devices are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, these wearables could provide continuous, objective sleep and activity data and offer a non-drug option (light therapy) to help improve sleep and reduce caregiver burden.
How similar studies have performed: Previous work has shown good compliance with research-grade actigraphy like GeneActiv even in late-stage AD, while light-therapy approaches have mixed but promising evidence for improving sleep and mood.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* For participants with dementia:
1. Clinical diagnosis of probable Alzheimer's disease (AD) or mild cognitive impairment (MCI) due to AD, based on established diagnostic criteria.
2. Presence of at least one prominent behavioral or psychological symptom of dementia (BPSD), including depression, agitation, apathy, or nighttime sleep disturbance.
3. Prominent is defined as:
NPI single-item score ≥ 4 (severity × frequency), or NPI-Q severity score ≥ 2, or PSQI total score ≥ 5 (if sleep disturbance is the main symptom).
4. Stable living arrangement or care environment for at least two weeks before enrollment.
5. If receiving any pharmacological or non-pharmacological treatments for BPSD, the dosage and frequency must have remained stable for at least two weeks prior to study participation.
6. Able and willing to provide informed consent; for those lacking decision-making capacity, consent must be obtained from a legally authorized representative.
* For primary caregivers:
1. Adult primary caregiver of the enrolled participant.
2. If receiving treatment for caregiver stress, the dosage and frequency must have been stable for at least two weeks before enrollment.
3. Willing and able to provide informed consent.
Exclusion Criteria:
* Any medical condition that may increase risk during participation, including:
1. Retinal disease, active use of photosensitizing medications, recent ocular surgery (within 4 weeks), or photosensitivity disorders (e.g., epilepsy).
2. Unstable physical or mental condition deemed unsuitable by investigators, such as acute delirium or active respiratory infection (including COVID-19)
Where this trial is running
Beigang, Yunlin
- China Medical University Beigang Hospital — Beigang, Yunlin, Taiwan (Recruiting)
Study contacts
- Study coordinator: Dr Ta-Wei Guu Consultant psychiatrist, MD, PhD
- Email: 066753@tool.caaumed.org.tw
- Phone: 05783790
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.