Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
24 participants
OBSERVATIONAL
2016-05-31
2019-08-31
Brief Summary
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Detailed Description
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This project proposes to develop, deploy, and evaluate such a tool and to address the fundamental scientific challenges to realizing the benefits of such a technology to caregivers and persons with dementia (PWD). The tool - BESI: Behavioral and Environmental Sensing and Intervention - will be an empowerment tool for caregivers of community-dwelling PWD. BESI comprises:
1. a system of body-worn inertial sensors and in-home acoustic, light, temperature, and motion sensors,
2. data analysis techniques to detect and assess agitation and environmental context from these sensor streams,
3. models for the relationship between agitation and the environment that are trained for each PWD-caregiver dyad based on a\&b, and
4. automated real-time notifications to the caregiver based on b\&c (e.g., detection of early agitation stages or of an environment (cumulative and/or instantaneous based on the models) that has led to agitation in the past), empowering the caregiver to intervene before agitation escalation.
Conditions
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Keywords
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Study Design
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FAMILY_BASED
CROSS_SECTIONAL
Study Groups
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Phase 1-Controlled Validation & Study Planning
Phase 1 is focused on refining and ultimately verifying BESI's basic sensing and notification functionality and validating BESI's environmental assessments in a controlled setting - namely the laboratory and homes of two healthy volunteers. This phase also serves to support further requirements gathering to refine BESI for community-based deployment. No interventions are delivered.
No interventions assigned to this group
Phase 2 - In-situ Validation and Ethnographic Analysis
Phase 2 starts the deployment of the technology within a community context, with the goals of validating the system's ability to assess agitation and environmental events in-situ and developing the cyber-sociophysical system models based on the dyad-specific relationship between agitation and the environment. A hybrid remote ethnographic methodology will be used, combining remote BESI measurement and caregiver diaries and a time-series design for the administration of the assessment battery.
No interventions assigned to this group
Phase 3 - Intervention with Home-Based Caregivers
Phase 3 is the intervention phase and the full realization of BESI. The goal is to employ the validated assessment capabilities and the developed modeling techniques to enable real-time, dyad-specific caregiver notifications that empower a caregiver to intervene with the PWD and/or environment before agitation escalation. In addition to validation of the BESI's ability to provide such appropriate notifications, Phase 3 will also serve as a pilot study about the effect that these notifications have on caregiver empowerment (as measured by self-efficacy) and the frequency and severity of PWD agitation, thus providing proof-of-concept for BESI's potential to improve dyad outcomes and motivating a larger-scale followup study to establish proof-of-practice.
Intervention with Home-Based Caregivers
We will assess whether real-time notifications of potential agitation via a wearable wrist device improves caregiver self-efficacy.
Interventions
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Intervention with Home-Based Caregivers
We will assess whether real-time notifications of potential agitation via a wearable wrist device improves caregiver self-efficacy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Living in one home for at least 2 months without hospitalization
* Caregiver seeking support for caregiving needs
* Have a stable caregiver
* Be able to provide consent or assent
Exclusion Criteria
* Multiple and inconsistent caregivers
* Living in multiple homes
* Unable to provide consent or assent
* No known dementia
50 Years
ALL
No
Sponsors
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Carilion Clinic
OTHER
North Carolina Agriculture & Technical State University
OTHER
University of Virginia
OTHER
Responsible Party
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Locations
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University of Virginia
Charlottesville, Virginia, United States
Countries
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Facility Contacts
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John Lach, Ph.D
Role: primary
Tonya Smith-Jackson, Ph.D
Role: backup
References
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Related Links
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Wearable device used in BESI
Other Identifiers
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1418622
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
0037457000
Identifier Type: -
Identifier Source: org_study_id