DementiaNCT07116122
Evaluating a Wearable Tracking System for Family Caregivers of Persons With Dementia With Wandering Concerns
A study testing Tracking/finding system in people with Dementia and Memory Loss, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Memory Loss, Caregiver
- What is being tested?
- Tracking/finding system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2026to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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 locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Transportation Research Institute
Ann Arbor, Michigan, 48109
About this study
Official title: 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
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
- Being tested
- Tracking/finding system
- Keywords
- dementia, memory loss, caregiver, dementia caregiver support, tracking device
- Medical subject headings
- Dementia, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tracking/finding systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Tracking/finding system | Experimental | Persons with dementia will wear the tracking device (Care Companion) and the caregivers will be using the companion smartphone application. Receives: Device: Tracking/finding system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 Month
Secondary outcomes (4)
Alzheimer's Disease (AD) and Alzheimer's Disease Related Dementias (ADRD) Negative Health Events and Service Utilization (stage I)
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.
Measured: 1 month
Lifespace Questionnaire (stage I)
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.
Measured: Baseline and 1 month
Alzheimer's Disease (AD) and Alzheimer's Disease Related Dementias (ADRD) Negative Health Events and Service Utilization (stage II)
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.
Measured: 6 month
Lifespace Questionnaire (stage II)
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.
Measured: Baseline and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study startFeb 2026 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Why it stopped: Device development took longer than anticipated and the study needed to be redesigned to not include device testing.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Koronis Biomedical Technologies, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Colleen Peterson, University of Michigan
- Investigators
- Colleen M Peterson, PhD, Principal investigator, University of Michigan Transportation Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116122
- Sponsor's protocol ID
- HUM00241188
- Other IDs
- 2R42AG058336-02A1
- Status last verified
- Feb 2026
- First submitted
- 4 Aug 2025
- Last updated
- 23 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07116122
- Acronym / sponsor ID
- HUM00241188
- Conditions
- Dementia, Memory Loss, Caregiver
- Keywords
- dementia, memory loss, caregiver, dementia caregiver support, tracking device
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Device development took longer than anticipated and the study needed to be redesigned to not include device testing.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Koronis Biomedical Technologies, National Institute on Aging (NIA)
- Study start
- Feb 2026 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Tracking/finding system | Experimental | Device: Tracking/finding systemPersons with dementia will wear the tracking device (Care Companion) and the caregivers will be using the companion smartphone application. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tracking/finding systemPersons 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. | Device | Tracking/finding system |
Primary outcome
Care Companion acceptability and utility (stage I)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
4 secondary outcomes
Alzheimer's Disease (AD) and Alzheimer's Disease Related Dementias (ADRD) Negative Health Events and Service Utilization (stage I)
Time frame: 1 month
Lifespace Questionnaire (stage I)
Time frame: Baseline and 1 month
Alzheimer's Disease (AD) and Alzheimer's Disease Related Dementias (ADRD) Negative Health Events and Service Utilization (stage II)
Time frame: 6 month
Lifespace Questionnaire (stage II)
Time frame: Baseline and 6 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colleen M Peterson, PhD principal investigator
University of Michigan Transportation Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tracking/finding system in people with Dementia and Memory Loss, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Care Companion acceptability and utility (stage I) (time frame: 1 Month). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.