Status:
COMPLETED
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
Lead Sponsor:
Evidation Health
Collaborating Sponsors:
Biomedical Advanced Research and Development Authority
Conditions:
Influenza, Human
COVID-19
Eligibility:
All Genders
18+ years
Brief Summary
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 o...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 21 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 7 2024
Estimated Enrollment :
18157 Patients enrolled
Trial Details
Trial ID
NCT06207929
Start Date
January 21 2024
End Date
August 7 2024
Last Update
September 5 2024
Active Locations (1)
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1
Evidation Health
San Mateo, California, United States, 94402