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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04623138

Enrollment

847

Registered

2020-11-10

Start date

2020-11-04

Completion date

2021-06-01

Last updated

2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, SARS-CoV Infection

Keywords

COVID-19, SARS-Cov Infection, SARS-CoV-2

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.)

Countries

United States

Outcome results