Studying Students at Risk for COVID-19

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

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Other: Wearable devices, saliva samples, survey measures

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.

• Study Type: Observational
• Enrollment (Actual): 2381

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Michigan Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Sung Won Choi, MD, MS, University of Michigan

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2020
• Primary Completion (Actual): January 26, 2023
• Study Completion (Actual): April 18, 2023

Study Registration Dates

• First Submitted: February 22, 2021
• First Submitted That Met QC Criteria: February 22, 2021
• First Posted (Actual): February 23, 2021

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 22, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Wearable Sensors, students
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: HUM00185391

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No