Covid19NCT04508972
The VOICE-COVID-19
An observational study of Covid19, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
The VOICE-COVID study will evaluate the concordance of screening for symptoms of COVID-19 using a voice based device (Amazon Alexa) compared to manual screening by a study coordinator for individuals entering the Cardiology/Heart Failure clinic at the McGill University Health Centre. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Alexa Amazon
- Type of treatment
- Medical device
- How many people
- 267 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2020to 30 Mar 2023
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Any employees or patients entering the Heart Failure clinic at the McGill University Health Center
Who may be able to join
- Adults >=18 yrs who is entering the HF clinic
- Speaks either English or French
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Voice-based Identification of Clinical Features Requiring Emergent Action in Patients With Suspected COVID-19 Infection (VOICE-COVID) I and II Study
The VOICE-COVID study will evaluate the concordance of screening for symptoms of COVID-19 using a voice based device (Amazon Alexa) compared to manual screening by a study coordinator for individuals entering the Cardiology/Heart Failure clinic at the McGill University Health Centre.
Read the detailed description
This study is an open-label, prospective, cross-over randomized study.
VOICE-COVID I: All individuals entering the Heart Failure (HF) Clinic of the McGill University Health Center will be asked to participate. A poster with instructions to ask the participants (employees or patients) to speak with the Amazon Alexa device. The participant will remain 6 feet away from the device. The Amazon Alexa will ask the survey questions. A study coordinator will then ask the same questions along with some additional questions about Amazon Alexa usability. VOICE-COVID II: A second cohort of 52 people will be then randomized to be screened for symptoms of COVID-19 with an Amazon Alexa or a coordinator. We will study the correlation between the Alexa response and the response to the study coordinator using K-squared statistic tests and screening question concordance.
- Conditions
- Covid19
- Being tested
- Alexa Amazon
- Keywords
- COVID-19, Alexa Device, Voice-based technologies, Screening, Safety
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alexa AmazonDevice
To test the use of the Amazon Alexa device as a tool to conduct screening of employees and patients at the point of entry into the Heart Failure (HF) Clinic of the McGill University Health Center.
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between data captured using Amazon Alexa compared to manual (human) collected data.
Determine the ability of the Amazon Alexa device to properly capture answers from participants and correlate with the answers retrieved by the study coordinator.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start1 Sep 2020
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Amazon Web Services (AWS) Canada
- Responsible party
- Principal investigator, Abhinav Sharma, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Abhinav Sharma, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04508972
- Sponsor's protocol ID
- 2020-6583
- Status last verified
- Aug 2023
- First submitted
- 10 Aug 2020
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We aim to disseminate these results through publications in peer review journals and submission to conferences. Currently, many conferences are converting into a virtual format which would enable our results to be disseminated over a wide audience.
Publications
Marques P, Emami A, Zhang G, Lopes RD, Razaghizad A, Avram R, Sharma A. Impact of age and comorbid heart failure on the utility of smart voice-assistant devices. Eur Heart J Digit Health. 2024 Feb 16;5(3):389-393. doi: 10.1093/ehjdh/ztae012. eCollection 2024 May.
PubMed 38774370Sharma A, Marques P, Zhang G, Oulousian E, Chung SH, Ganni E, Lopes RD, Razaghizad A, Avram R. Voice-assisted Artificial Intelligence-enabled Screening for Severe Acute Respiratory Syndrome Coronavirus 2 Exposure in Cardiovascular Clinics: Primary Results of the VOICE-COVID-19-II Randomized Trial. J Card Fail. 2023 Oct;29(10):1456-1460. doi: 10.1016/j.cardfail.2023.05.004. Epub 2023 May 22.
PubMed 37224994Oulousian E, Chung SH, Ganni E, Razaghizad A, Zhang G, Avram R, Sharma A. Voice-Based Screening for SARS-CoV-2 Exposure in Cardiovascular Clinics (VOICE-COVID-19-II): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Jan 31;12:e41209. doi: 10.2196/41209.
PubMed 36719720Sharma A, Oulousian E, Ni J, Lopes R, Cheng MP, Label J, Henriques F, Lighter C, Giannetti N, Avram R. Voice-based screening for SARS-CoV-2 exposure in cardiovascular clinics. Eur Heart J Digit Health. 2021 Jun 16;2(3):521-527. doi: 10.1093/ehjdh/ztab055. eCollection 2021 Sep.
PubMed 36713601
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voice-based Identification of Clinical Features Requiring Emergent Action in Patients With Suspected COVID-19 Infection (VOICE-COVID) I and II Study
- ClinicalTrials.gov ID
- NCT04508972
- Acronym / sponsor ID
- 2020-6583
- Conditions
- Covid19
- Keywords
- COVID-19, Alexa Device, Voice-based technologies, Screening, Safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Amazon Web Services (AWS) Canada
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 11 Aug 2020 (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 VOICE-COVID study will evaluate the concordance of screening for symptoms of COVID-19 using a voice based device (Amazon Alexa) compared to manual screening by a study coordinator for individuals entering the Cardiology/Heart Failure clinic at the McGill University Health Centre.
Detailed description
This study is an open-label, prospective, cross-over randomized study.
VOICE-COVID I: All individuals entering the Heart Failure (HF) Clinic of the McGill University Health Center will be asked to participate. A poster with instructions to ask the participants (employees or patients) to speak with the Amazon Alexa device. The participant will remain 6 feet away from the device. The Amazon Alexa will ask the survey questions. A study coordinator will then ask the same questions along with some additional questions about Amazon Alexa usability. VOICE-COVID II: A second cohort of 52 people will be then randomized to be screened for symptoms of COVID-19 with an Amazon Alexa or a coordinator. We will study the correlation between the Alexa response and the response to the study coordinator using K-squared statistic tests and screening question concordance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Any employees or patients entering the Heart Failure clinic at the McGill University Health Center
Key inclusion criteria (2 listed)
- Adults >=18 yrs who is entering the HF clinic
- Speaks either English or French
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Alexa AmazonTo test the use of the Amazon Alexa device as a tool to conduct screening of employees and patients at the point of entry into the Heart Failure (HF) Clinic of the McGill University Health Center. | Device | – |
Primary outcome
Correlation between data captured using Amazon Alexa compared to manual (human) collected data.
Time frame: Day 1
Determine the ability of the Amazon Alexa device to properly capture answers from participants and correlate with the answers retrieved by the study coordinator.
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 7 Aug 2023.
- Derived from this study: PubMed 38774370Marques P, Emami A, Zhang G, Lopes RD, Razaghizad A, Avram R, Sharma A. Impact of age and comorbid heart failure on the utility of smart voice-assistant devices. Eur Heart J Digit Health. 2024 Feb 16;5(3):389-393. doi: 10.1093/ehjdh/ztae012. eCollection 2024 May.
- Derived from this study: PubMed 37224994Sharma A, Marques P, Zhang G, Oulousian E, Chung SH, Ganni E, Lopes RD, Razaghizad A, Avram R. Voice-assisted Artificial Intelligence-enabled Screening for Severe Acute Respiratory Syndrome Coronavirus 2 Exposure in Cardiovascular Clinics: Primary Results of the VOICE-COVID-19-II Randomized Trial. J Card Fail. 2023 Oct;29(10):1456-1460. doi: 10.1016/j.cardfail.2023.05.004. Epub 2023 May 22.
- Derived from this study: PubMed 36719720Oulousian E, Chung SH, Ganni E, Razaghizad A, Zhang G, Avram R, Sharma A. Voice-Based Screening for SARS-CoV-2 Exposure in Cardiovascular Clinics (VOICE-COVID-19-II): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Jan 31;12:e41209. doi: 10.2196/41209.
- Derived from this study: PubMed 36713601Sharma A, Oulousian E, Ni J, Lopes R, Cheng MP, Label J, Henriques F, Lighter C, Giannetti N, Avram R. Voice-based screening for SARS-CoV-2 exposure in cardiovascular clinics. Eur Heart J Digit Health. 2021 Jun 16;2(3):521-527. doi: 10.1093/ehjdh/ztab055. eCollection 2021 Sep.
- Individual participant dataSharing planned: Undecided. We aim to disseminate these results through publications in peer review journals and submission to conferences. Currently, many conferences are converting into a virtual format which would enable our results to be disseminated over a wide audience.
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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.
Abhinav Sharma, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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 2 inclusion and 1 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 7 Aug 2023. 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 Canada. 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?
Correlation between data captured using Amazon Alexa compared to manual (human) collected data. (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04508972, which also lists 4 linked publications.
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 7 Aug 2023.