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

Completed

• Conditions: Covid19; SARS-CoV Infection

• Registration Number: NCT04623138
• Lead Sponsor: Evidation Health

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-30
• Study Start: 2020-11-04
• Study First Submitted QC: 2020-11-06
• Study First Posted: 2020-11-10
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-20
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 847

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of database containing physiological, behavioral data in combination with SARS-CoV-2 infection	Through study completion, an average of 7 months	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.
Correlation between SARS-CoV-2 infection and collected wearable data and self-reported data	Through study completion, an average of 7 months	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.

Secondary Outcome Measures

Name	Time	Method
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+).	Through study completion, an average of 7 months	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.)

Trial Locations

Locations (1)

Evidation Health; 🇺🇸 San Mateo, California, United States