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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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)

Study Design

Phase
Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Study Population Adult participants (ages 18+) who reside in the contiguous United States

Recruiting Locations

Evidation Health
San Mateo, California 94402
Contact:
Ernesto Ramirez, PhD

More Details

NCT ID
NCT06207929
Status
Recruiting
Sponsor
Evidation Health

Study Contact

Ernesto Ramirez, PhD
415-650-4741
wavestudy@evidation.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.