Clinical trial NCT04766788: Studying Students at Risk for COVID-19
Official title: Monitoring Beliefs and Physiological Measures in Students at Risk for COVID-19 Using Wearable Sensors and Smartphone Technology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: Wearable Sensors, students
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 2381
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Students at the University of Michigan must be either coming to campus or reside in the United States.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of wearing Fitbit device
timeFrame: 4 months
Secondary outcomes:
measure: Survey completion
timeFrame: Up to 9 months
measure: Saliva sample
timeFrame: Up to 4 months
measure: Continuous heart rate
timeFrame: Up to 8 months
measure: Mental well-being
timeFrame: Up to 9 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Michigan Medicine
state: Michigan
Study officials:
affiliation: University of Michigan
name: Sung Won Choi, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.