A Virtual Prospective Study Exploring Activity Trackers and COVID-19 Infections

Study Overview
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Brief Summary
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Prospective, observational, exploratory study exploring the relationship between passively-collected data from wearable activity devices and SARS-CoV-2 infection

Official Title
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A Decentralized, Prospective Study Exploring the Relationship Between Passively-collected Data From Wearable Activity Devices and SARS-CoV-2 Infection

Conditions
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Covid19, SARS-CoV Infection

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults 18+ years of age Lives in the United States Speaks, reads, and understands English Willing and able to use and wear a wrist-worn activity device daily, during the day and during sleep, or as much as is possible, for the duration of the study Meets minimum software and device requirements for the wrist-worn activity device (Apple iOS 12 and up, Android version 6.0 and up) Willing to answer daily, weekly and monthly surveys for the duration of the study Willing to provide weekly self-collected saliva samples, plus one additional sample if prompted to do so (up to 9 total samples), and ship back the sample(s) within 24 hours of sample collection Exclusion Criteria: Self-reported previous diagnosis of COVID-19 Currently participating in any type of clinical trial Lives in the District of Columbia (Washington D.C.), Alaska, Hawaii, Arizona, Nevada, U.S. military base located overseas, or U.S. territories (Puerto Rico, U.S. Virgin Islands, Guam, Northern Mariana Island, or American Samoa)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Garmin Study Device Group<br>Individuals who are randomly assigned to receive the Garmin vívosmart® 4 | |
| Empatica Study Device Group<br>Individuals who are randomly assigned to receive the Empatica E4 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of database containing physiological, behavioral data in combination with SARS-CoV-2 infection | To develop a database of physiological and behavioral data via wearable devices and self-reported questionnaires (e.g.,symptoms) combined with laboratory confirmation of SARS- CoV-2 infection. | Through study completion, an average of 7 months | 
| Correlation between SARS-CoV-2 infection and collected wearable data and self-reported data | Physiological and behavioral data from wearable devices (Garmin vivosmart 4, Empatica E4) , patient self-reported data questionnaires (includes but is not limited to demographics, symptoms, medical history, lifestyle, comorbidities, and Medical care utilization), and laboratory diagnostic confirmation of SARS-CoV-2 infection. | Through study completion, an average of 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lift of the analytical models as expressed as the ratio of COVID-19+ recall (COVID-19+ cases detected by model as a percentage of total positive cases)/Healthy false positives (healthy cases detected by the model as being COVID-19+). | Lift is a measure of model performance and will be evaluated at multiple timepoints along the infection time-course (for example, 1 day prior to illness onset, onset, day 3, etc.) | Through study completion, an average of 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, SARS-Cov Infection, SARS-CoV-2