Evaluating a Wearable Tracking System for Family Caregivers of Persons With Dementia With Wandering Concerns
NCT ID: NCT07116122
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
140 participants
INTERVENTIONAL
2026-02-28
2026-08-31
Brief Summary
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Participants in this stage 1 will be involved in this project for approximately 1 month and stage II participants will be involved for approximately 6 months.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Tracking/finding system
Persons with dementia will wear the tracking device (Care Companion) and the caregivers will be using the companion smartphone application.
Tracking/finding system
Persons living with Alzheimer's Disease or Related dementias will wear the Care Companion smartwatch for approximately one month (stage I) or 6 months (stage 2). The Caretakers will utilize the smart phone application (app) to monitor the person wearing the watch and be alerted to elopements. The system will notify a caregiver if the person with dementia leaves a defined area (e.g., the home) via the application. In the tether mode (e.g., outside of the home), the system monitors the distance between the smartwatch and the caregiver's smartphone. When a separation distance exceeds a set threshold, the application will alert the caregiver and start tracking the location of the person with dementia by displaying the person's position on the caregiver's smartphone.
Interventions
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Tracking/finding system
Persons living with Alzheimer's Disease or Related dementias will wear the Care Companion smartwatch for approximately one month (stage I) or 6 months (stage 2). The Caretakers will utilize the smart phone application (app) to monitor the person wearing the watch and be alerted to elopements. The system will notify a caregiver if the person with dementia leaves a defined area (e.g., the home) via the application. In the tether mode (e.g., outside of the home), the system monitors the distance between the smartwatch and the caregiver's smartphone. When a separation distance exceeds a set threshold, the application will alert the caregiver and start tracking the location of the person with dementia by displaying the person's position on the caregiver's smartphone.
Eligibility Criteria
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Inclusion Criteria
* Has concerns about person living with dementia/memory loss wandering or eloping
* Have a smartphone (Android or Apple) with sufficient system requirements (e.g., iPhone 4s or better) or indicate a willingness to use the Care Companion and related smart phone application
* Able to converse in English and understand written English
* Must have internet and computer access capable of Zoom
* In the research staff's best judgment can:
* engage and assist the person with dementia wearing the device
* complete surveys via the internet
* engage in feedback on the devices (surveys and, if applicable, interview)
* Are unable to meet device use and orientation schedule requirements
* Have a provider diagnosis of AD/ADRD or caregiver has demonstrated it via the screening
* Willing to wear the Care Companion device for the duration of the study
* Able to converse in English
* Currently residing in a nursing home setting without regular outings
18 Years
ALL
Yes
Sponsors
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Koronis Biomedical Technologies
INDUSTRY
National Institute on Aging (NIA)
NIH
University of Michigan
OTHER
Responsible Party
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Colleen Peterson
Assistant Research Scientist
Principal Investigators
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Colleen M Peterson, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan Transportation Research Institute
Locations
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University of Michigan Transportation Research Institute
Ann Arbor, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HUM00241188
Identifier Type: -
Identifier Source: org_study_id