Wide Scale Monitoring for Acute Respiratory Infection Using a Mobile-Based Study Platform

Completed

• Conditions: Influenza; Acute Respiratory Distress Syndrome; Respiratory Tract Infections; Acute Respiratory Tract Infection; Covid19

• Registration Number: NCT04663776
• Lead Sponsor: Boston Children's Hospital

Brief Summary

This is a prospective observational study using a mobile study platform (app) that is designed for use on Android phones. Study participants will provide baseline demographic and medical information and report symptoms of respiratory infection on a weekly basis using the app. Participants will also report use of prevention techniques on the weekly survey. Mobility data will be collected passively using the sensors on the participant's smartphone, if the participant has granted the proper device permissions. The overall goals of the study are to track spread of coronavirus-like illness (CLI), influenza-like illness (ILI) and non-specific respiratory illness (NSRI) on a near-real time basis and identify specific behaviors associated with an increased or decreased risk of developing these conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-04
• Study First Submitted: 2020-12-05
• Study First Submitted QC: 2020-12-05
• Study First Posted: 2020-12-11
• Primary Completion: 2021-12-08
• Study Completion: 2021-12-08
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-04
• Last Update Posted: 2022-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16000

Inclusion Criteria

• Adult 18 years or older, Android mobile phone user, Resides in the United States (has a US home address)

Exclusion Criteria

• Under the age of 18, Does not use an Android mobile device, Opts out of sharing mobility data, Does not live within the United States

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of influenza-like illness (ILI) and COVID-like illness (CLI) in a study participant.	6-month participation period	The definition of ILI will be adapted from CDC guidelines as a participant reporting fever in addition to cough or sore throat without any other known cause. All study analyses and outcomes will be reported using federated analytics. Federated analytics utilizes aggregated responses, rather than individual subject reports. Due to this, when reporting the final outcome, the total incidence may not add up to exactly 100%.
Incidence of COVID-like illness (CLI) in a study participant.	6-month participation period	CLI will be defined as fever and cough, or shortness of breath, or loss of smell. Incidence will be defined as reporting of the above symptoms in the 7 days prior (and not previously). All study analyses and outcomes will be reported using federated analytics. Federated analytics utilizes aggregated responses, rather than individual subject reports. Due to this, when reporting the final outcome, the total incidence may not add up to exactly 100%.

Secondary Outcome Measures

Name	Time	Method
Disease Prevalence	1-year study period	Patterns of mobility (e.g. time away from home, use of public transportation), and reported use of prevention strategies such as wearing a mask and social distancing in participants who do, or don't, develop CIL and/or ILI will be compared. All study analyses and outcomes will be reported using federated analytics. Federated analytics utilizes aggregated responses, rather than individual subject reports. Due to this, when reporting the final outcome, the total prevalence may not add up to exactly 100%.

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States