Wearable tools to support dementia care in rural Taiwan

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.