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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06170528
• Other study ID #: STUDY00003184
• Status: Recruiting
• Phase: N/A
• Start date: November 16, 2022
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Florida State University
• Contact: HyeJin Park, PhD
• Phone: 8506445345
• Email: hpark5[@]fsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The purpose of this study is to reduce the care burdens of people with mild cognitive impairment or mild dementia and their caregivers using Fitbit watches and Amazon Echo devices. Couples will be both recruited and provided with consent forms that explain the study.

In the first phase, after the informed consent, selected dyads will participate in two focus groups will take 60 minutes per each. For this, a research staff will schedule a zoom meeting and then will show the short introduction video regarding Alexa and Fitbit, lists of voice interaction with Alexa, and lists of Fitbit conversation. After this, each dyad will participate in one focus groups interview. Participants will be compensated with a $50.00 gift card to this phase of the study.

In the second phase, a researcher will visit each dyad's home to set up Amazon Echo and Fitbit. The research staff will train participants in use of the Amazon Echo device and Fitbit. A web camera will be set up in the living room. This visit will take about three hours. The camera will run for three hours, and then be removed from the home setting. Two routers, the Amazon echo, Fitbit watch and iPad will remain in the home for two weeks. Signals from two routers will capture activities. Couples will contact the researcher with questions. During the two weeks data on movement, sitting, lying, walking, drinking, eating, falls, washing face, brushing teeth, and location data of the patients as detected by the WIFI router. Daily reminders will be given through the voice assisted ECHO system for routine activities of daily living including time to eat, taking medication, etc. At the end of the two-week study period, measurements will be made on usability, acceptability of the use of the system. Participants will be compensated with another $50.00 gift card for completing this phase of the study.

There are minimal risks in performing the research procedures that consist of a survey, interview, and testing feasibility of the device. However, PI will continuously monitor any harms or discomfort from participants.

Data reporting: Information we learn about participants in this study will be handled in a confidential manner, within the limits of the law. If we publish the results of the study in a scientific journal or book, we will not identify participants. The Institutional Review Board and other groups that have the responsibility of monitoring research may want to see study records which identify the participants as a subject in this study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2024
• Est. primary completion date: July 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

Inclusion Criteria:

• To be included, dyads of persons with ADRD and their family caregivers must meet the following criteria:

1. 1 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),

2. at least 1 caregiver living in the same household for at least 4 hours per day for at least the past 6 months,

3. both individuals within the dyads be at least 18 years of age,

4. both individuals within the dyads have sufficient vision and speaking capabilities to use a voice-enabled system, and

5. both individuals within the dyads live in a community setting in Tallahassee or assisted living setting inTallahassee.

Exclusion Criteria,

1. Person is diagnosed with Moderate and Sever ADRD

2. No caregivers living in the same household

3. Both individuals with less 18 years of age

4. Both individuals within the dyads have language barriers

Related Conditions & MeSH terms

• Alzheimer Disease
• Caregiver Burden

Intervention

Device:
• AURA_ALZ
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.

Locations

Country	Name	City	State
United States	Florida State University College of nursing	Tallahassee	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Florida State University	The University of Texas Health Science Center at San Antonio, University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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