Behavioral and Environmental Sensing and Intervention

NCT03297268 | Unknown

• 2 other identifiers: 00374570001418622
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

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

Interventions

Intervention with Home-Based Caregivers OTHER

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

Also known as: Real-time caregiver notifications

Phase 3 - Intervention with Home-Based Caregivers

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Community sample of people with dementia living at home with unpaid caregivers.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Virginia: lead
• Carilion Clinic: collaborator
• North Carolina Agriculture & Technical State University: collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22904, United States

RECRUITING

Related Publications (33)

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Related Links

• Wearable device used in BESI

MeSH Terms

Conditions

Behavior; Dementia; Caregiver Burden; Aberrant Motor Behavior in Dementia

Interventions

Methods

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Stress, Psychological; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2017
• First Posted: September 29, 2017
• Study Start: May 1, 2016
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: September 29, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)