Alzheimer DiseaseNCT06170528
ARUA-ALZ - Connecting Audio and Radio SensingmSystems to Improve Care at Home for ADRD
A study testing AURA_ALZ in people with Alzheimer Disease and Caregiver Burden, run by Florida State University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Alzheimer Disease, Caregiver Burden
- What is being tested?
- AURA_ALZ
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2022to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be included, dyads of persons with ADRD and their family caregivers must meet the following criteria:
- 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),
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University College of nursing
Tallahassee, Florida, 32306
About this study
Official title: ARUA-ALZ - Connecting Audio and Radio Sensing Systems to Improve Care at Home for ADRD
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.
Read the detailed 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.
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.
- Conditions
- Alzheimer Disease, Caregiver Burden
- Being tested
- AURA_ALZ
- Medical subject headings
- Alzheimer Disease, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AURA_ALZDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Mild ADRA and their caregivers | Other | Deployed the AURA_ALZ system at Home Receives: Device: AURA_ALZ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: At two weeks after deployment of system
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start16 Nov 2022
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, The University of Texas Health Science Center at San Antonio
- Responsible party
- Principal investigator, Jing Wang, Florida State University
- Investigators
- Jing Wang, PhD, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170528
- Sponsor's protocol ID
- STUDY00003184
- Status last verified
- Aug 2024
- First submitted
- 19 Oct 2023
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARUA-ALZ - Connecting Audio and Radio Sensing Systems to Improve Care at Home for ADRD
- ClinicalTrials.gov ID
- NCT06170528
- Acronym / sponsor ID
- STUDY00003184
- Conditions
- Alzheimer Disease, Caregiver Burden
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, The University of Texas Health Science Center at San Antonio
- Study start
- 16 Nov 2022 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mild ADRA and their caregivers | Other | Device: AURA_ALZDeployed the AURA_ALZ system at Home |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- To be included, dyads of persons with ADRD and their family caregivers must meet the following criteria:
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AURA_ALZAURA_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. | Device | Mild ADRA and their caregivers |
Primary outcome
Usability of use of the AURA_ALZ system will be determined
Time frame: At two weeks after deployment of system
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.
Acceptability of use of the AURA_ALZ system will be determined
Time frame: At two weeks after deployment of system
Interviews will be conducted with all study participants to ask about their acceptability of the AURA-ALZ system
Feasibility of use of the AURA_ALZ system will be determined
Time frame: At two weeks after deployment of system
Feasibility will be determined by the retention rates.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Wang, PhD principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AURA_ALZ in people with Alzheimer Disease and Caregiver Burden, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of use of the AURA_ALZ system will be determined (time frame: At two weeks after deployment of system). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.