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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04663776
Recruitment Status : Completed
First Posted : December 11, 2020
Last Update Posted : March 7, 2022
Sponsor:
Collaborator:
Google LLC.
Information provided by (Responsible Party):
John Brownstein, Boston Children's Hospital

Study Description
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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

Study Design
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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 : November 4, 2020
Actual Primary Completion Date : December 8, 2021
Actual Study Completion Date : December 8, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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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%.


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Contacts and Locations
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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
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children's Hospital
Google LLC.
More Information
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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: March 7, 2022
Last Verified: March 2022
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