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

Not Applicable

Not yet recruiting

• Conditions: Dementia; Caregiver; Memory Loss

• Registration Number: NCT07116122
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-04
• Study First Submitted QC: 2025-08-04
• Last Update Submitted: 2025-08-04
• Study First Posted: 2025-08-11
• Last Update Posted: 2025-08-11
• Study Start: 2025-11-01
• Primary Completion: 2026-08-31
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Care Companion acceptability and utility (stage I)	1 Month	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.
Caregiver Well-Being (stage I)	Baseline and 1 month	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.
Wandering and Elopement Behaviors (stage I)	Baseline and 1 month	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.
Care Companion Semi-Structured Feasibility Interview (stage I)	1 Month	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.
Care Companion acceptability and utility (stage II)	6 Month	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.
Caregiver Well-Being (stage II)	Baseline and 6 month	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.
Wandering and Elopement Behaviors (stage II)	Baseline and 1 month	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.
Care Companion Semi-Structured Feasibility Interview (stage II)	6 Month	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.

Secondary Outcome Measures

Name	Time	Method
Alzheimer's Disease (AD) and Alzheimer's Disease Related Dementias (ADRD) Negative Health Events and Service Utilization (stage I)	1 month	Number of crises and service utilization (including number of nursing home stays, number of bed days, assisted living stays in the past month, other residential care setting in the past month, overnight hospital stays in past month, and Emergency visits in past month) will be measured with five self-report items. Whether the event happened is a yes/no format, if yes, the study will sum the number of days or events.
Lifespace Questionnaire (stage I)	Baseline and 1 month	Perceptions of environmental and community mobility of the person with dementia will be assessed with the Lifespace Questionnaire (LSQ). Caregivers will also be asked how frequently the person with dementia took trips outside of the home. The composite score ranges from 0-9, with higher scores representing greater mobility and access to the community and lower scores indicating limited mobility and likely restriction to home.
Alzheimer's Disease (AD) and Alzheimer's Disease Related Dementias (ADRD) Negative Health Events and Service Utilization (stage II)	6 month	Number of crises and service utilization (including number of nursing home stays, number of bed days, assisted living stays in the past month, other residential care setting in the past month, overnight hospital stays in past month, and Emergency visits in past month) will be measured with five self-report items. Whether the event happened is a yes/no format, if yes, the study will sum the number of days or events.
Lifespace Questionnaire (stage II)	Baseline and 6 month	Perceptions of environmental and community mobility of the person with dementia will be assessed with the Lifespace Questionnaire (LSQ). Caregivers will also be asked how frequently the person with dementia took trips outside of the home. The composite score ranges from 0-9, with higher scores representing greater mobility and access to the community and lower scores indicating limited mobility and likely restriction to home.

Trial Locations

Locations (1)

University of Michigan Transportation Research Institute; 🇺🇸 Ann Arbor, Michigan, United States