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 Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
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.
University of Michigan Transportation Research Institute
Ann Arbor, Michigan, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 Month
Care Companion acceptability and utility (stage II)
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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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 Month
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.
Time frame: 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.
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)
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.
Time frame: 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.
Time frame: Baseline and 6 month