Behavioral and Environmental Sensing and Intervention (BESI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03297268|
Recruitment Status : Recruiting
First Posted : September 29, 2017
Last Update Posted : September 29, 2017
|Condition or disease||Intervention/treatment|
|Behavioral and Psychiatric Symptoms of Dementia Dementia Caregivers||Other: Intervention with Home-Based Caregivers|
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.
|Study Type :||Observational|
|Estimated Enrollment :||24 participants|
|Official Title:||Behavioral and Environmental Sensing and Intervention for Dementia Caregiver Empowerment|
|Actual Study Start Date :||May 2016|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||August 2019|
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.
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.
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.
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.
Other Name: Real-time caregiver notifications
- Improved Caregiver Self-Efficacy [ Time Frame: 30 days ]Increased scores on Revised Scale for Caregiver Self-Efficacy
- Decreased Caregiver Burden [ Time Frame: 30 days ]Zarit Burden Interview score lowered
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03297268
|United States, Virginia|
|University of Virginia||Recruiting|
|Charlottesville, Virginia, United States, 22904|
|Contact: John Lach, Ph.D email@example.com|
|Contact: Tonya Smith-Jackson, Ph.D firstname.lastname@example.org|
|Principal Investigator: Azziza Bankole, M.D.|
|Sub-Investigator: Martha Anderson, DNP|