Behavioral and Environmental Sensing and Intervention

• Conditions: Dementia; Caregivers; Behavioral and Psychiatric Symptoms of Dementia
• Interventions: Other: Intervention with Home-Based Caregivers

• Registration Number: NCT03297268
• Lead Sponsor: University of Virginia

Brief Summary

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.

Detailed Description

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:

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.

Study Timeline

• Study Start: 2016-05
• Status Verified: 2017-09
• Study First Submitted: 2017-09-20
• Study First Submitted QC: 2017-09-27
• Last Update Submitted: 2017-09-27
• Study First Posted: 2017-09-29
• Last Update Posted: 2017-09-29
• Primary Completion: 2019-08
• Study Completion: 2019-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Diagnosis of dementia
• 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

• Hospitalization in the last 2 months
• Multiple and inconsistent caregivers
• Living in multiple homes
• Unable to provide consent or assent
• No known dementia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Phase 3 - Intervention with Home-Based Caregivers	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.

Primary Outcome Measures

Name	Time	Method
Improved Caregiver Self-Efficacy	30 days	Increased scores on Revised Scale for Caregiver Self-Efficacy
Decreased Caregiver Burden	30 days	Zarit Burden Interview score lowered

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States