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

December 20, 2021 updated by: Evidation Health

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

847

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Mateo, California, United States, 94402
        • Evidation Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult participants (ages 18+) who reside in the contiguous United States and are at elevated risk of contracting COVID-19.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Garmin Study Device Group
Individuals who are randomly assigned to receive the Garmin vívosmart® 4
Empatica Study Device Group
Individuals who are randomly assigned to receive the Empatica E4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of database containing physiological, behavioral data in combination with SARS-CoV-2 infection
Time Frame: 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.
Through study completion, an average of 7 months
Correlation between SARS-CoV-2 infection and collected wearable data and self-reported data
Time Frame: 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.
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+).
Time Frame: 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.)
Through study completion, an average of 7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Evidation Health

Collaborators

Eli Lilly and Company
United States Department of Defense
Bill and Melinda Gates Foundation
Biomedical Advanced Research and Development Authority
Vir Biotechnology, Inc.

Investigators

  • Principal Investigator: Ernesto Ramirez, PhD, Evidation Health
  • Principal Investigator: Luca Foschini, PhD, Evidation Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2020

Primary Completion (Actual)

June 1, 2021

Study Completion (Actual)

June 1, 2021

Study Registration Dates

First Submitted

October 30, 2020

First Submitted That Met QC Criteria

November 6, 2020

First Posted (Actual)

November 10, 2020

Study Record Updates

Last Update Posted (Actual)

January 11, 2022

Last Update Submitted That Met QC Criteria

December 20, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID Signals

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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