Official Title
Wearable Assisted Viral Evidence (WAVE) Study A Decentralized, Prospective Study Exploring the Relationship Between Passively-collected Data From Wearable Activity Devices and Respiratory Viral Infections
Brief Summary

The goal of this decentralized, observational study is to enroll and observe adults inthe contingent United States during the 2023-2024 flu season. The main study objectivesare to create a dataset of paired wearable data, self-reported symptoms, and respiratoryviral infection (RVI) from PCR testing during the 2023-2024 flu season and to developalgorithm that is able to accurately classify asymptomatic and symptomatic RVI andunderstand the algorithm's performance metrics.

Detailed Description

Not Provided

Completed
Influenza, Human
COVID-19
Influenza A
Influenza B
Respiratory Syncytial Virus (RSV)
Eligibility Criteria

Inclusion Criteria:

- Lives in the United States

- Speaks, reads, and understands English

- Currently owns and uses a consumer wearable device (Apple Watch, Garmin, or Fitbit)
with necessary step and heart rate data at minimum or willing to wear a
study-provided device and download the Fitbit app

- Willing to connect their wearable device to the Evidation platform and wear it daily
for at least 10 hours for the duration of the study

- Owns a smartphone with Apple iOS 15 installed or higher OR Android version 9.0
installed or higher or willing to update

- Willing to respond to daily and weekly questionnaires for a 10-week period

- Willing to complete at-home nasal swab tests and return the nasal swab samples
within 24 hours of being asked to complete it

- Meets data density requirements for wearable devices

Exclusion Criteria:

- Self reported diagnosis of both flu and COVID by a healthcare professional or using
an at-home test in the past 3 months

- Currently enrolled in another interventional study to prevent or treat COVID-19 or
another flu-related program being conducted by Evidation (individuals currently
participating in Evidation's FluSmart program will be told that their participation
will be paused)

- Has a primary mailing address that is a P.O box, Army Post Office (APO), Fleet Post
Office (FPO), or Diplomatic Post Office (DPO) address, or U.S. military base located
overseas, or U.S. territories (Puerto Rico, U.S. Virgin Islands, Guam, Northern
Mariana Island, or American Samoa)

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

Evidation Health
San Mateo 5392423, California 5332921, United States

Ernesto Ramirez, PhD, Principal Investigator
Evidation Health

Biomedical Advanced Research and Development Authority
NCT Number
Keywords
Flu
Influenza
RSV
Covid
Wearable
MeSH Terms
Influenza, Human
COVID-19