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
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Care Companion acceptability and utility (stage I)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Tracking/finding system
Persons with dementia will wear the tracking device (Care Companion) and the caregivers will be using the companion smartphone application.
干预措施: Tracking/finding system (Device)
结局指标
主要结局
Care Companion acceptability and utility (stage I)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- 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)
研究者
Colleen Peterson
Assistant Research Scientist
University of Michigan