Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
10034 participants
OBSERVATIONAL
2023-06-28
2024-06-15
Brief Summary
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Detailed Description
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Participants will be asked to complete an e-consent via a REDCap survey. If participants have questions, they are provided with study contact information via e-mail. Participants will complete the survey which will have questions on prior symptoms and device ownership (anticipated time to complete: 5 minutes). If the participant owns one of the following wearable devices (Fitbit, Garmin, or Apple Watch), they will be sent to a redirect URL to login into their device account (for Fitbit or Garmin) or be provided with instructions to export their Healthkit data and dump their data into a unique Strongbox link (for Apple Watch). If participants choose to contribute their wearable device data to the study and the data obtained pass through data quality thresholds, they will receive compensation. There is no compensation for survey completion. The investigators will ask participants if they wish to be re-contacted for future studies related to this project.
The investigators will collect endpoint data values from the wearable. These data will be used to estimate daily activity amounts and intensity (i.e., exercise and walking), standing, sleep amounts, sleep quality, heart rate variability, SpO2, respiratory rate, and heart rate. All of the wearable device data will be identified using a Study ID.
The investigators will use statistical and machine learning models to develop personalized "baseline" models of health and detect anomalies that can help in identifying COVID-19 infection. The investigators will validate and test the sensitivity and specificity of our mode for detecting respiratory infection vs. no infection against symptom surveys and diagnostic testing as ground truth. The model testing and validation will be done separately for each brand of device and will be further modified according to the type of respiratory infection.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Adults 18 years of age and up
The study will recruit any adult over the age of 18 years.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Biomedical Advanced Research and Development Authority
FED
Duke University
OTHER
Responsible Party
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Principal Investigators
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Chris Woods
Role: PRINCIPAL_INVESTIGATOR
Duke University
Jessilyn Dunn
Role: PRINCIPAL_INVESTIGATOR
Duke University
Ryan Shaw
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University
Durham, North Carolina, United States
Countries
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Other Identifiers
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PRO00106404
Identifier Type: -
Identifier Source: org_study_id
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