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

NCT07116122 | Withdrawn

• 2 other identifiers: HUM002411882R42AG058336-02A1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

dementia; memory loss; caregiver; dementia caregiver support; tracking device

Outcome Measures

Primary Outcomes (8)

• Care Companion acceptability and utility (stage I)

  Caregivers will report the utility and perceptions system review checklist with 18 close-ended questions on a 5-point Likert scale (e.g., "Setting up the Care Companion system was easy") and 7 open-ended questions (e.g., "How do think the Care Companion system affected how you care for your relative?"). Scores can range from 18 to 90, with a higher score indicating higher acceptability and utility. Individual items will be reviewed for particular factor utility.

  1 Month

• Caregiver Well-Being (stage I)

  Caregiver burden will be assessed using the 19-item Benjamin Rose Institute Caregiver Strain Instrument. It is rated on a 4-point Likert scale. Scores greater than 8 for Mastery, greater than 10 for Relationship Strain or Health Strain, or greater than 5 for Social Isolation/Activity Restriction may indicate heightened risk and may warrant further clinical investigation.

  Baseline and 1 month

• Wandering and Elopement Behaviors (stage I)

  Caregivers will use the 27-item Algase Wandering Scale-Version 2 (AWS-V2) measures ambulation patterns to indicate their care recipient's restlessness and inclination to wander and elopement frequency (e.g., boundary transgressions), which has been validated with community-dwelling persons with Alzheimer's Disease Related Dementias (ADRD). This scale will be modified to use the Likert scaling approach to reduce survey burden. The total score ranges from 23-92 with higher scores indicating more frequent wandering behaviors.

  Baseline and 1 month

• Care Companion Semi-Structured Feasibility Interview (stage I)

  All Stage I participants will be asked to participate in a semi-structured interview to learn more about perceptions related cost, sensitivity of the geo-locating, appearance, and privacy or stigma concerns. This information will be summarized into codes and higher level themes using qualitative analysis approaches.

  1 Month

• Care Companion acceptability and utility (stage II)

  Caregivers will report the utility and perceptions system review checklist with 18 close-ended questions on a 5-point Likert scale (e.g., "Setting up the Care Companion system was easy") and 7 open-ended questions (e.g., "How do think the Care Companion system affected how you care for your relative?"). Scores can range from 18 to 90, with a higher score indicating higher acceptability and utility. Individual items will be reviewed for particular factor utility.

  6 Month

• Caregiver Well-Being (stage II)

  Caregiver burden will be assessed using the 19-item Benjamin Rose Institute Caregiver Strain Instrument. It is rated on a 4-point Likert scale. Scores greater than 8 for Mastery, greater than 10 for Relationship Strain or Health Strain, or greater than 5 for Social Isolation/Activity Restriction may indicate heightened risk and may warrant further clinical investigation.

  Baseline and 6 month

• Wandering and Elopement Behaviors (stage II)

  Caregivers will use the 27-item Algase Wandering Scale-Version 2 (AWS-V2) measures ambulation patterns to indicate their care recipient's restlessness and inclination to wander and elopement frequency (e.g., boundary transgressions), which has been validated with community-dwelling persons with Alzheimer's Disease Related Dementias (ADRD). This scale will be modified to use the Likert scaling approach to reduce survey burden. The total score ranges from 23-92 with higher scores indicating more frequent wandering behaviors.

  Baseline and 1 month

• Care Companion Semi-Structured Feasibility Interview (stage II)

  A subset of Stage II participants will be asked to participate in a semi-structured interview to learn more about perceptions related cost, sensitivity of the geo-locating, effect on caregiving, appearance, and privacy or stigma concerns related to the design. This information will be summarized into codes and higher level themes using qualitative analysis approaches.

  6 Month

Secondary Outcomes (4)

• Alzheimer's Disease (AD) and Alzheimer's Disease Related Dementias (ADRD) Negative Health Events and Service Utilization (stage I)

  1 month

• Lifespace Questionnaire (stage I)

  Baseline and 1 month

• Alzheimer's Disease (AD) and Alzheimer's Disease Related Dementias (ADRD) Negative Health Events and Service Utilization (stage II)

  6 month

• Lifespace Questionnaire (stage II)

  Baseline and 6 month

Study Arms (1)

Tracking/finding system

EXPERIMENTAL

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

Device: Tracking/finding system

Interventions

Tracking/finding system DEVICE

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.

Tracking/finding system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Koronis Biomedical Technologies: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Michigan Transportation Research Institute

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Dementia; Memory Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Colleen M Peterson, PhD

  University of Michigan Transportation Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Research Scientist

Model Details: A total of 70 (20 in stage 1, 50 in stage II) caregivers as well as the persons with Alzheimer's Disease (AD) will participate. Therefore, the number of anticipated enrollment is 140.

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 11, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)