Behavioral and Environmental Sensing and Intervention

Study Overview
=================
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: a system of body-worn inertial sensors and in-home acoustic, light, temperature, and motion sensors, data analysis techniques to detect and assess agitation and environmental context from these sensor streams, models for the relationship between agitation and the environment that are trained for each PWD-caregiver dyad based on a&b, and 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.

Official Title
-----------------
Behavioral and Environmental Sensing and Intervention for Dementia Caregiver Empowerment

Conditions
-----------------
Dementia, Behavioral and Psychiatric Symptoms of Dementia, Caregivers

Intervention / Treatment
-----------------
* Other: Intervention with Home-Based Caregivers


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Phase 1-Controlled Validation & Study Planning<br>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 - In-situ Validation and Ethnographic Analysis<br>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 - Intervention with Home-Based Caregivers<br>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<br>* We will assess whether real-time notifications of potential agitation via a wearable wrist device improves caregiver self-efficacy.<br>* Other names: Real-time caregiver notifications;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved Caregiver Self-Efficacy | Increased scores on Revised Scale for Caregiver Self-Efficacy | 30 days | 
| Decreased Caregiver Burden | Zarit Burden Interview score lowered | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dementia Caregiver Empowerment, Caregiver Burden, Agitation in Dementia, Environmental Sensors, Wearable Technology