Studying Students at Risk for COVID-19

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

2381 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-03

Study Completion Date

2023-04-18

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.

Conditions

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Covid19

Keywords

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Wearable Sensors, students

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Sung Won Choi

Edith S Briskin and Shirley K Schlafer Foundation Research Professor of Pediatrics and Associate Professor of Pediatrics and Communicable Diseases

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sung Won Choi, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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Michigan Medicine

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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Cislo C, Clingan C, Gilley K, Rozwadowski M, Gainsburg I, Bradley C, Barabas J, Sandford E, Olesnavich M, Tyler J, Mayer C, DeMoss M, Flora C, Forger DB, Cunningham JL, Tewari M, Choi SW. Monitoring beliefs and physiological measures in students at risk for COVID-19 using wearable sensors and smartphone technology: Protocol for a mobile health study. JMIR Res Protoc. 2021 Jun 4;10(6):e29561. doi: 10.2196/29561. Online ahead of print.

Reference Type BACKGROUND

PMID: 34115607 (View on PubMed)

Gilley KN, Baroudi L, Yu M, Gainsburg I, Reddy N, Bradley C, Cislo C, Rozwadowski ML, Clingan CA, DeMoss MS, Churay T, Birditt K, Colabianchi N, Chowdhury M, Forger D, Gagnier J, Zernicke RF, Cunningham JL, Cain SM, Tewari M, Choi SW. Risk Factors for COVID-19 in College Students Identified by Physical, Mental, and Social Health Reported During the Fall 2020 Semester: Observational Study Using the Roadmap App and Fitbit Wearable Sensors. JMIR Ment Health. 2022 Feb 10;9(2):e34645. doi: 10.2196/34645.