Recruiting

Behavioral Sensing

Sponsor:

University of Virginia

Code:

NCT03297268

Conditions

Behavioral and Psychiatric Symptoms of Dementia

Dementia

Caregivers

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Intervention with Home-Based Caregivers

Study Details

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.

Conditions

Behavioral and Psychiatric Symptoms of Dementia

Dementia

Caregivers

Study ID

NCT03297268

Start date

May, 2016

Status verified date

Sep, 2017

Completion date

Aug, 2019

Anticipated

Primary completion date

Aug, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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

Enrollment

24 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Intervention with Home-Based Caregivers

We will assess whether real-time notifications of potential agitation via a wearable wrist device improves caregiver self-efficacy.

Primary outcome measure

  • Improved Caregiver Self-Efficacy [ Time Frame: 30 days ]
  • Decreased Caregiver Burden [ Time Frame: 30 days ]

Central Contacts and Locations

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22904

Contacts

John Lach, Ph.D

jlach@virginia.edu

Tonya Smith-Jackson, Ph.D

tlsmithj@ncat.edu

Principal Investigator:

Azziza Bankole, M.D.

More Information

Sponsor

University of Virginia

Last update posted

Sep 29, 2017

Last verified

Sep, 2017

Keywords

  • Dementia Caregiver Empowerment
  • Caregiver Burden
  • Agitation in Dementia
  • Environmental Sensors
  • Wearable Technology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2017-09-29.