ARUA-ALZ - Connecting Audio and Radio SensingmSystems to Improve Care at Home for ADRD

NCT06170528 | Completed FDA Device

• 1 other identifier: STUDY00003184
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to address the unmet care needs and reduce the care burdens for persons with ADRD (Alzheimer's Disease and Alzheimer's Disease Related Dementias) and their caregivers by providing monitoring of daily activities and gestures using audio and radio sensing, providing voice-based reminders intervention. In phase 1, dyads will participate in two focus groups will take 60 minutes per each. In Phase 2, AURA\_ALZ (connecting Audio and Radio Sensing Systems-Alzheimer's Disease) will deployed for two weeks at participants' home. At the end of the two weeks, usability, acceptability of the use of the system will be measured.

Conditions

Alzheimer Disease; Caregiver Burden

Outcome Measures

Primary Outcomes (3)

• Usability of use of the AURA_ALZ system will be determined

  Usability Scale (rating from 1 to 5 with the higher score is better)adapted for the evaluation of AURA-ALZ will be administered to assess the usability of AURA-ALZ.

  At two weeks after deployment of system

• Acceptability of use of the AURA_ALZ system will be determined

  Interviews will be conducted with all study participants to ask about their acceptability of the AURA-ALZ system

  At two weeks after deployment of system

• Feasibility of use of the AURA_ALZ system will be determined

  Feasibility will be determined by the retention rates.

  At two weeks after deployment of system

Study Arms (1)

Mild ADRA and their caregivers

OTHER

Deployed the AURA\_ALZ system at Home

Device: AURA_ALZ

Interventions

AURA_ALZ DEVICE

AURA\_ALZ includes the WiFi CSI-based human sensing algorithms, as well as the voice and web interfaces. The devices of AURA\_ALZ consists of Fitbit watch, iPad, ASUS routers, Jetson nano, webcam, and Amazon Echo.

Mild ADRA and their caregivers

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be included, dyads of persons with ADRD and their family caregivers must meet the following criteria:
• person must be diagnosed with ADRD from a physician. Caregivers must self-report that their person's dementia diagnosis from a physician and self-report Global Deterioration Scale (GDS) rating for care recipients to determine stage of dementia. Eligible participants must characterize their person's ADRD symptoms as fitting with Stages 3 and 4 (defined as mild cognitive impairment to mild dementia of Alzheimer's type),
• at least 1 caregiver living in the same household for at least 4 hours per day for at least the past 6 months,
• both individuals within the dyads be at least 18 years of age,
• both individuals within the dyads have sufficient vision and speaking capabilities to use a voice-enabled system, and
• both individuals within the dyads live in a community setting in Tallahassee or assisted living setting inTallahassee.

You may not qualify if:

• Person is diagnosed with Moderate and Sever ADRD
• No caregivers living in the same household
• Both individuals with less 18 years of age
• Both individuals within the dyads have language barriers

Sponsors & Collaborators

• Florida State University: lead
• University of North Carolina, Chapel Hill: collaborator
• The University of Texas Health Science Center at San Antonio: collaborator

Study Sites (1)

Florida State University College of nursing

Tallahassee, Florida, 32306, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Caregiver Burden

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Jing Wang, PhD

  Florida State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: FSU Site Principal Investigator

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: December 14, 2023
• Study Start: November 16, 2022
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)