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

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ClinicalTrials.gov Identifier: NCT04663776
Recruitment Status : Recruiting
First Posted : December 11, 2020
Last Update Posted : December 11, 2020
Sponsor:
Collaborator:
Google LLC.
Information provided by (Responsible Party):
John Brownstein, 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.

Condition or disease
Covid19 Influenza Respiratory Tract Infections Acute Respiratory Tract Infection Acute Respiratory Distress Syndrome

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Study Type : Observational
Estimated Enrollment : 100000 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 : November 4, 2020
Estimated Primary Completion Date : December 8, 2021
Estimated Study Completion Date : December 8, 2021





Primary Outcome Measures :
  1. Incidence of influenza-like illness (ILI) and COVID-like illness (CLI) in a study participant. [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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%.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population will be adult Android mobile device users who live within the United States.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04663776


Locations
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United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: John Brownstein, PhD    617-355-6000    john.brownstein@childrens.harvard.edu   
Principal Investigator: John Brownstein, PhD         
Sponsors and Collaborators
Boston Children's Hospital
Google LLC.
Publications:

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Responsible Party: John Brownstein, Chief Innovation Officer, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT04663776    
Other Study ID Numbers: P00036213
First Posted: December 11, 2020    Key Record Dates
Last Update Posted: December 11, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All study data is reported as aggregates in federated analytics. We have language that we have the option to share aggregate data within our protocol and consent, though it is not guaranteed that it will be done. No individual participant data is available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Respiratory Tract Infections
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Disease Attributes
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury