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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04663776

Enrollment

16000

Registered

2020-12-11

Start date

2020-11-04

Completion date

2021-12-08

Last updated

2022-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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%.

Countries

United States

Outcome results