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NCT04508972 Clinical Trial

The VOICE-COVID-19

Covid19 Clinical Trial

Official title:
Voice-based Identification of Clinical Features Requiring Emergent Action in Patients With Suspected COVID-19 Infection (VOICE-COVID) I and II Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04508972
Other study ID # 2020-6583
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date March 30, 2023

Study information
Verified date August 2023
Source McGill University Health Centre/Research Institute of the McGill University Health Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 267
Est. completion date March 30, 2023
Est. primary completion date March 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adults >=18 yrs who is entering the HF clinic - Speaks either English or French Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

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.

Locations
Country Name City State
Canada Muhc-Rimuhc Montreal Quebec

Sponsors (2)
Lead Sponsor Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre Amazon Web Services (AWS) Canada

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Other Self reported Likert scale on comfort in using the Amazon Alexa device Day 1
Primary 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. Day 1
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