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

NCT04663776 | Completed

• 1 other identifier: P00036213
• Study Type: observational
• Target: 16,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Influenza; Respiratory Tract Infections; Acute Respiratory Tract Infection; Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (2)

• Incidence of influenza-like illness (ILI) and COVID-like illness (CLI) in a study participant.

  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%.

  6-month participation period

• Incidence of COVID-like illness (CLI) in a study participant.

  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%.

  6-month participation period

Secondary Outcomes (1)

• Disease Prevalence

  1-year study period

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be adult Android mobile device users who live within the United States.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Google LLC.: collaborator

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (17)

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MeSH Terms

Conditions

COVID-19; Influenza, Human; Respiratory Tract Infections; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections; Respiration Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Innovation Officer

Study Record Dates

• First Submitted: December 5, 2020
• First Posted: December 11, 2020
• Study Start: November 4, 2020
• Primary Completion: December 8, 2021
• Study Completion: December 8, 2021
• Last Updated: March 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)