Studying Students at Risk for COVID-19

Completed

• Conditions: Covid19

• Registration Number: NCT04766788
• Lead Sponsor: University of Michigan

Brief Summary

The goal of this longitudinal observational study is to learn about how the COVID-19 has impacted and continues to impact students at the University of Michigan. We hope to determine whether a combination of (1) continuous heart rate obtained from wearable devices, (2) self-reported data from surveys and symptom logs, and (3) saliva samples can be used to help students self-monitor for infection and eventually be able to create a predictive model to detect illness early.

Detailed Description

The study was originally intended to last one year, however, it was expanded to follow the study participants over several years.

During this study, participants will be asked to:

* Provide a baseline self-collected saliva sample

* Download and use a suite of mobile apps (e.g., Fitbit, Social Rhythms, Roadmap 2.0)

* Complete surveys online

* Wear non-invasive Fitbit smartwatch

* Grant the study team access to their university academic records (optional)

The study will use these tools to monitor participants' physical activity and mental health over the course of at least three years. The study will also examine whether there is a connection between mental health and academic performance.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-09-03
• Study First Submitted: 2021-02-22
• Study First Submitted QC: 2021-02-22
• Study First Posted: 2021-02-23
• Primary Completion: 2023-01-26
• Study Completion: 2023-04-18
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-22
• Last Update Posted: 2023-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2381

Inclusion Criteria

• Students at the University of Michigan who have moved back to Ann Arbor or who are completing schooling completely online.
• For those completing school online, must be able to provide a mailing address within the United States where they can receive study tools
• Possession of a smartphone (Apple or Andriod)
• Ability to understand and demonstrate willingness to sign a written informed consent.

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Exclusion Criteria

• Unwilling or unable to comply with the study procedures.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of wearing Fitbit device	4 months	Feasibility will will be defined as wearing the Fitbit watch at least 8 hours per day up to at least 5 days of the week

Secondary Outcome Measures

Name	Time	Method
Saliva sample	Up to 4 months	Analyze samples to determine a possible early prediction/detection model for COVID-19
Survey completion	Up to 9 months	Completion will be measured by the number of participants who complete the study surveys
Mental well-being	Up to 9 months	Assess participant mental well-being during the COVID-19 pandemic and if the use of health and well-being applications impacts self-rated well-being
Continuous heart rate	Up to 8 months	Analyze heart rate data to determine a possible early prediction/detection model for COVID-19

Trial Locations

Locations (1)

Michigan Medicine; 🇺🇸 Ann Arbor, Michigan, United States