Behavioral and Environmental Sensing and Intervention

Dementia Clinical Trial

— BESI  

Official title:

Behavioral and Environmental Sensing and Intervention for Dementia Caregiver Empowerment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03297268
• Other study ID #: 0037457000
• Secondary ID: 1418622
• Status: Recruiting
• Phase: N/A
• First received: September 20, 2017
• Last updated: September 27, 2017
• Start date: May 2016
• Est. completion date: August 2019

Study information

• Verified date: September 2017
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Behavioral and Psychiatric Symptoms of Dementia
• Caregivers
• Dementia

Intervention

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.

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
University of Virginia	Carilion Clinic, North Carolina Agricultural and Technical State University

Country where clinical trial is conducted

United States, 

References & Publications (33)

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved Caregiver Self-Efficacy	Increased scores on Revised Scale for Caregiver Self-Efficacy	30 days
Primary	Decreased Caregiver Burden	Zarit Burden Interview score lowered	30 days

External Links

•   Wearable device used in BESI