An interventional study of AURA_ALZ in Alzheimer Disease and Caregiver Burden, sponsored by Florida State University. Completed at 1 site in United States. Open to participants aged 18 Years to 110 Years. Per ClinicalTrials.gov, last updated 2024-08-23.
Sponsored by Florida State University · Not applicable, Interventional, and Device feasibility
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.
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.
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 the investigators learn about participants in this study will be handled in a confidential manner, within the limits of the law. If investigators publish the results of the study in a scientific journal or book, no participants will be identified. 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.
3,765 studies on the registry are indexed under Alzheimer Disease; 881 are open to participants now.
This study's enrollment of 9 is below the median of 68 across 2,861 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Florida State University is the lead sponsor of 245 studies on the registry; 46 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 9 (56%) have results posted.
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To be included, dyads of persons with ADRD and their family caregivers must meet the following criteria:
Exclusion Criteria,
Deployed the AURA\_ALZ system at Home
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.
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.
Time frame: 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
Time frame: 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.
Time frame: At two weeks after deployment of system
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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