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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. Read our disclaimer for details. Identifier: NCT03297268
Recruitment Status : Unknown
Verified September 2017 by University of Virginia.
Recruitment status was:  Recruiting
First Posted : September 29, 2017
Last Update Posted : September 29, 2017
Carilion Clinic
North Carolina Agriculture & Technical State University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Behavioral and Psychiatric Symptoms of Dementia Dementia Caregivers Other: Intervention with Home-Based Caregivers

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.

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Study Type : Observational
Estimated Enrollment : 24 participants
Observational Model: Family-Based
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. Improved Caregiver Self-Efficacy [ Time Frame: 30 days ]
    Increased scores on Revised Scale for Caregiver Self-Efficacy

  2. Decreased Caregiver Burden [ Time Frame: 30 days ]
    Zarit Burden Interview score lowered

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community sample of people with dementia living at home with unpaid caregivers.

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03297268

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United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22904
Contact: John Lach, Ph.D   
Contact: Tonya Smith-Jackson, Ph.D   
Principal Investigator: Azziza Bankole, M.D.         
Sub-Investigator: Martha Anderson, DNP         
Sponsors and Collaborators
University of Virginia
Carilion Clinic
North Carolina Agriculture & Technical State University
Additional Information:
Hall GR, Gerdner LA, Zwygart-Stauffacher M, et al: Principles of nonpharmacological management: Caring for people with Alzheimer's disease using a conceptual model. Psychiatric Annals 1995; 25(7):432-440
Gerdner LA, Buckwalter KC, Hall GR: Temporal patterning of agitation and stressors associated with agitation: Case profiles to illustrate the Progressively Lowered Stress Threshold model. Journal of the American Psychiatric Nurses Association 2005; 11(4):215-222
Logsdon RG, Gibbons LE, McCurry, et al: Quality of life in Alzheimer's disease: Patient and caregiver reports. Journal of Mental Health and Ageing 1999; 5:21-32

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Responsible Party: University of Virginia Identifier: NCT03297268    
Other Study ID Numbers: 0037457000
1418622 ( Other Grant/Funding Number: National Science Foundation )
First Posted: September 29, 2017    Key Record Dates
Last Update Posted: September 29, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Virginia:
Dementia Caregiver Empowerment
Caregiver Burden
Agitation in Dementia
Environmental Sensors
Wearable Technology
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Neurodegenerative Diseases