Caregiver, Dementia, Memory Loss
Conditions
Keywords
dementia, memory loss, caregiver, dementia caregiver support, tracking device
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.
Interventions
DEVICETracking/finding system
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.
Sponsors
University of Michigan
Koronis Biomedical Technologies
National Institute on Aging (NIA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORColleen M Peterson, PhD
University of Michigan Transportation Research Institute
Outcome results
None listed