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

Evidation Health

Status

Completed

Conditions

Influenza A

COVID-19

Influenza, Human

Respiratory Syncytial Virus (RSV)

Influenza B

Study type

Observational

Funder types

Industry

Other U.S. Federal agency

Identifiers

NCT06207929

WAVE Study

Details and patient eligibility

About

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

Enrollment

18,157 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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)