Clincosm LogoSign in Get a demo

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

Sponsor
Boston Children's Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04663776
Collaborator
Google LLC. (Industry)
16,000
Enrollment
1
Location
13.1
Actual Duration (Months)
1220.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    16000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Wide Scale Monitoring for Acute Respiratory Infection Using a Mobile-Based Study Platform
    Actual Study Start Date :
    Nov 4, 2020
    Actual Primary Completion Date :
    Dec 8, 2021
    Actual Study Completion Date :
    Dec 8, 2021

    Outcome Measures

    Primary Outcome Measures

    1. 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%.

    2. 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

    1. 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%.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Boston Children's Hospital Boston Massachusetts United States 02115

    Sponsors and Collaborators

    • Boston Children's Hospital
    • Google LLC.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    John Brownstein, Chief Innovation Officer, Boston Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT04663776
    Other Study ID Numbers:
    • P00036213
    First Posted:
    Dec 11, 2020
    Last Update Posted:
    Mar 7, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Respiratory Tract Infections
    Respiratory Distress Syndrome
    Respiratory Distress Syndrome, Newborn
    Acute Lung Injury

    Study Results

    No Results Posted as of Mar 7, 2022