An observational study in Behavioral and Psychiatric Symptoms of Dementia, Dementia and Caregivers, sponsored by University of Virginia. Status unknown at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2017-09-29.
Sponsored by University of Virginia · Observational
This 3-phase research plan to employ Behavioral and Environmental Sensing and Intervention (BESI) will overcome the fundamental scientific barriers to realizing prediction of agitation episodes and detection early stages of dementia related agitation. The goal of which is empowering caregivers to intervene early and ultimately reduce agitation, thus reducing caregiver burden and extending aging-in-place and improving the associated quality-of-life and cost benefits.
The dementia syndrome of Alzheimer's disease and other disorders is rapidly expanding due to the aging of society and the longevity of citizens. In its varying stages, care of the dementia syndrome requires differing sets of skills from the caregivers, and more skilled intervention is required as the disease progresses. These caregivers experience increased burden due to the challenges and stresses of caring. A recent systematic review of caregiver burden factors revealed dementia-related agitation to be the most prevalent factor leading caregivers to institutionalize community-dwelling loved ones with dementia. Tools that empower caregivers to proactively reduce the incidents and severity of agitation would reduce stress and increase self-efficacy, thereby extending aging-in-place and the associated quality-of-life and cost benefits.
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:
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This study's planned enrollment of 24 is below the median of 235 across 341 observational studies indexed under Behavior.
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Community sample of people with dementia living at home with unpaid caregivers.
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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.
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.
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.
Other: Intervention with Home-Based Caregivers
We will assess whether real-time notifications of potential agitation via a wearable wrist device improves caregiver self-efficacy.
Also known as: Real-time caregiver notifications
Improved Caregiver Self-Efficacy
Increased scores on Revised Scale for Caregiver Self-Efficacy
Time frame: 30 days
Decreased Caregiver Burden
Zarit Burden Interview score lowered
Time frame: 30 days
Plan to share: No
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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