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

University of Michigan

Status: Not yet enrolling

Conditions: Memory Loss; Caregiver; Dementia

Treatments: Device: Tracking/finding system

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT07116122

2R42AG058336-02A1 (U.S. NIH Grant/Contract)

HUM00241188

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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140 participants in 1 patient group

Tracking/finding system

Experimental group

Description:

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

Treatment:

Device: Tracking/finding system