WithdrawnNot Applicable

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

Stopped: Device development took longer than anticipated and the study needed to be redesigned to not include device testing.

United States0Started 2026-02

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Caregiver Inclusion Criteria: * Identify as person providing support to the person living with dementia/memory loss due to person's dementia * 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) Caregiver Exclusion Criteria: * Do not meet inclusion criteria * Are unable to meet device use and orientation schedule requirements Persons Living with Dementia or Memory Loss Inclusion Criteria: * 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 Persons Living with Dementia or Memory Loss Exclusion Criteria: * Do not meet inclusion criteria above * Currently residing in a nursing home setting without regular outings

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Care Companion acceptability and utility (stage I)

Timeframe: 1 Month

Caregiver Well-Being (stage I)

Timeframe: Baseline and 1 month

Wandering and Elopement Behaviors (stage I)

Timeframe: Baseline and 1 month

Care Companion Semi-Structured Feasibility Interview (stage I)

Timeframe: 1 Month

Care Companion acceptability and utility (stage II)

Timeframe: 6 Month

Caregiver Well-Being (stage II)

Timeframe: Baseline and 6 month

Wandering and Elopement Behaviors (stage II)

Timeframe: Baseline and 1 month

Care Companion Semi-Structured Feasibility Interview (stage II)

Trial details

NCT IDNCT07116122

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-31

View on ClinicalTrials.gov More Dementia trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Care Companion acceptability and utility (stage I)

Timeframe: 1 Month

Caregiver Well-Being (stage I)

Timeframe: Baseline and 1 month

Wandering and Elopement Behaviors (stage I)

Timeframe: Baseline and 1 month

Care Companion Semi-Structured Feasibility Interview (stage I)

Timeframe: 1 Month

Care Companion acceptability and utility (stage II)

Timeframe: 6 Month

Caregiver Well-Being (stage II)

Timeframe: Baseline and 6 month

Wandering and Elopement Behaviors (stage II)

Timeframe: Baseline and 1 month

Care Companion Semi-Structured Feasibility Interview (stage II)