NCT07116122

Evaluating a Wearable Tracking System for Family Caregivers of Persons With Dementia With Wandering Concerns

A Two-Stage Pilot Study to Evaluate the Feasibility (Stage I) and Efficacy (Stage II) of a Tracking System for Family Caregivers of Persons With Dementia

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This project has two stages feasibility (stage 1) and efficacy of the device (stage II) and is being completed to evaluate a tracking solution system (Care Companion) developed by Koronis Biomedical Technologies (KBT) to assist family caregivers of persons living with dementia that are at risk for wandering/elopement. 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.

Conditions

• Dementia
• Memory Loss
• Caregiver

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2026-02-01
• Primary completion: 2026-08-31
• Completion: 2026-08-31
• First posted: 2025-08-11
• Last updated: 2026-02-23

Locations

1 site across 1 country: United States