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The VOICE-COVID-19

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ClinicalTrials.gov Identifier: NCT04508972
Recruitment Status : Recruiting
First Posted : August 11, 2020
Last Update Posted : September 28, 2020
Sponsor:
Collaborators:
Amazon Web Services (AWS) Canada
University of California
Information provided by (Responsible Party):
Abhinav Sharma, McGill University Health Centre/Research Institute of the McGill University Health Centre

Tracking Information
First Submitted Date August 10, 2020
First Posted Date August 11, 2020
Last Update Posted Date September 28, 2020
Actual Study Start Date July 1, 2020
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 10, 2020)
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, we will use a linear regression approach to model the relationship between both surveys
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The VOICE-COVID-19
Official Title Voice-based Identification of Clinical Features Requiring Emergent Action in Patients With Suspected COVID-19 Infection (VOICE-COVID) Study
Brief 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.
Detailed Description

This study is an open-label, non-interventional, prospective study.

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. We will study the correlation between the Alexa response and the response to the study coordinator using K-squared statistic tests.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Any employees or patients entering the Heart Failure clinic at the McGill University Health Center
Condition Covid19
Intervention Device: Alexa Amazon
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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 14, 2020)
200
Original Estimated Enrollment
 (submitted: August 10, 2020)
50
Estimated Study Completion Date November 1, 2020
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adults >=18 yrs who is entering the HF clinic
  • Speaks either English or French

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Abhinav Sharma, MD 514 934-1934 abhinav.sharma@mcgill.ca
Contact: Julie Lebel 514 934-1934 ext 38106 julie.lebel@muhc.mcgill.ca
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT04508972
Other Study ID Numbers 2020-6583
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Plan Description: 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.
Responsible Party Abhinav Sharma, McGill University Health Centre/Research Institute of the McGill University Health Centre
Study Sponsor McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
  • Amazon Web Services (AWS) Canada
  • University of California
Investigators
Principal Investigator: Abhinav Sharma, MD McGill University Health Centre/Research Institute of the McGill University Health Centre
PRS Account McGill University Health Centre/Research Institute of the McGill University Health Centre
Verification Date September 2020