Wearable Tracking System for Dementia

Overseen By Hannah E Wheeler, MLIS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Nursing home, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new device, Care Companion, designed to help caregivers track loved ones with dementia who might wander or get lost. The trial will assess whether the device is easy to use and effectively prevents risky situations. Caregivers who support someone with dementia and worry about wandering, as well as individuals with a dementia diagnosis willing to wear the device, are sought for participation. Participants must have a smartphone and be able to engage with an app and provide feedback online. As an unphased trial, this study offers participants the opportunity to contribute to innovative solutions for dementia care.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this wearable tracking system is safe for persons with dementia?

Research has shown that technology like the Care Companion can help keep people with dementia safe. These systems often include features like real-time tracking, which alerts caregivers if someone wanders away.

While specific safety data for the Care Companion device is not yet available, similar technologies are designed to be safe and user-friendly. They aim to enhance care without causing harm to the user, which is crucial for patients with dementia who may struggle with more complex devices.

The current trial is in an early stage called "feasibility." This stage assesses the practicality and ease of use of the device before evaluating its effectiveness. Any potential safety issues are likely to be identified and addressed before the device is used more widely.

Overall, the Care Companion is designed to be a helpful tool for caregivers, emphasizing safety and ease of use for those with dementia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Care Companion because it offers a fresh approach to managing dementia. Unlike traditional treatments that primarily focus on medication or caregiver support, this wearable tracking system provides real-time location monitoring, enhancing safety for individuals with dementia. It also includes a smartphone application for caregivers, allowing them to easily track and locate their loved ones, reducing stress and improving peace of mind. This combination of technology and caregiving support is a novel way to address the challenges of dementia care.

What evidence suggests that the Care Companion is effective for assisting caregivers of persons with dementia?

Research shows that the Care Companion tracking system, used by participants in this trial, helps caregivers monitor individuals with dementia who might wander or get lost. Early results suggest that wearable devices like this can effectively manage real-time information and enhance patient care. Although specific data on the Care Companion's effectiveness in reducing wandering is not yet available, similar devices have proven to provide safe monitoring. This system could be particularly beneficial for caregivers in tracking their loved ones' locations. The study will further investigate the device's effectiveness in everyday situations. ^{1 2 6 7 8}

Who Is on the Research Team?

Colleen M Peterson, PhD

Principal Investigator

University of Michigan Transportation Research Institute

Are You a Good Fit for This Trial?

This trial is for family caregivers of individuals with dementia who are at risk of wandering. Participants will help evaluate a new tracking system called Care Companion, developed to assist in monitoring their loved ones.

Inclusion Criteria

Able to converse in English and understand written English

Must have internet and computer access capable of Zoom

Willing to wear the Care Companion device for the duration of the study

Exclusion Criteria

Do not meet inclusion criteria above

Do not meet inclusion criteria

Are unable to meet device use and orientation schedule requirements

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Feasibility Stage (Stage I)

Participants use the Care Companion tracking system for feasibility assessment

1 month

Baseline and 1-month visits

Efficacy Stage (Stage II)

Participants use the Care Companion tracking system for efficacy assessment

6 months

Baseline and 6-month visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Care Companion

Trial Overview The study is testing the feasibility and effectiveness of the Care Companion tracking system over two stages: stage I lasts about 1 month, and stage II extends to approximately 6 months.

How Is the Trial Designed?

Group I: Tracking/finding system Experimental Treatment 1 Intervention

Persons with dementia will wear the tracking device (Care Companion) and the caregivers will be using the companion smartphone application.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Koronis Biomedical Technologies

Industry Sponsor

Trials

4

Recruited

200+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12120371/

Advancing Remote Monitoring for Patients With Alzheimer ... This advancement facilitates effective device management and real-time data monitoring and offers a secure storage solution, enhancing patient care and ...

2. withpower.com withpower.com/trial/phase-dementia-10-2025-9e950

Wearable Tracking System for Dementia · Info for Participants Trial Overview The study is testing the feasibility and effectiveness of the Care Companion tracking system over two stages: stage I lasts about 1 month, and ...

3. nature.com nature.com/articles/s41598-025-14624-6

A smart secure virtual reality immersive application for ... The heart of the system is a real-time AI companion, implemented using ChatGPT 3.5 Turbo, and tailored for dementia care and emotional support.

4. clinconnect.io clinconnect.io/trials/NCT07116122

Evaluating a Wearable Tracking System for Family - ClinConnect The study has two parts: first, a short one-month trial to see if the device is easy to use, followed by a longer six-month period to check how well it works.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2274580724006794

Digital Health Technologies for Alzheimer's Disease and ... Digital health technologies offer valuable advantages to dementia researchers and clinicians as screening tools, diagnostic aids, and monitoring instruments.

6. joghr.org joghr.org/article/39606-technology-for-dementia-care-benefits-opportunities-and-concerns

Technology for dementia care: benefits, opportunities and ... These solutions promise enhanced mechanisms to manage lifestyle, monitor cognitive performance, ensure the security and safety of the elderly, ...

7. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.14192

Technology that CARES: Enhancing dementia care through ... The CARES framework provides direction for scholars to evaluate how technology might influence patient and care partner centered outcomes via ...

8. mdpi.com mdpi.com/2079-9292/14/17/3516

LumiCare: A Context-Aware Mobile System for Alzheimer's ... These data points can provide valuable insights into subtle changes in behavior and physical function indicative of disease progression or emergencies.