Studying Students at Risk for COVID-19

Study Overview
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Brief Summary
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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
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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.

Official Title
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Monitoring Beliefs and Physiological Measures in Students at Risk for COVID-19 Using Wearable Sensors and Smartphone Technology

Conditions
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Covid19

Intervention / Treatment
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* Other: Wearable devices, saliva samples, survey measures


Participation Criteria
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Eligibility Criteria
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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. Exclusion Criteria: Unwilling or unable to comply with the study procedures.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Wearable devices, saliva samples, survey measures|Provide a self-collected saliva sample, download and use the suite of apps (e.g., Fitbit, Social Rhythms, Roadmap 2.0), and answer online surveys.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of wearing Fitbit device | 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 | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survey completion | Completion will be measured by the number of participants who complete the study surveys | Up to 9 months | 
| Saliva sample | Analyze samples to determine a possible early prediction/detection model for COVID-19 | Up to 4 months | 
| Continuous heart rate | Analyze heart rate data to determine a possible early prediction/detection model for COVID-19 | Up to 8 months | 
| Mental well-being | 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 | Up to 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wearable Sensors, students