Studying Students at Risk for COVID-19

NCT04766788 | Completed

• 1 other identifier: HUM00185391
• Study Type: observational
• Target: 2,381
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

Wearable Sensors, students

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Survey completion

  Up to 9 months

• Saliva sample

  Up to 4 months

• Continuous heart rate

  Up to 8 months

• Mental well-being

  Up to 9 months

Interventions

Wearable devices, saliva samples, survey measures OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Unwilling or unable to comply with the study procedures.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

Michigan Medicine

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (3)

• 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.

  PMID: 34115607 BACKGROUND

• 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.

  PMID: 34992051 BACKGROUND

• Jayaraj G, Cao X, Horwitz A, Rozwadowski M, Shea S, Hanauer SN, Hanauer DA, Tewari M, Shedden K, Choi SW. Trends in Mental Health Outcomes of College Students Amid the Pandemic (Roadmap mHealth App): Longitudinal Observational Study. J Med Internet Res. 2025 Jan 9;27:e67627. doi: 10.2196/67627.

  PMID: 39787592 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Wearable Electronic Devices

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• Sung Won Choi, MD, MS

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Edith S Briskin and Shirley K Schlafer Foundation Research Professor of Pediatrics and Associate Professor of Pediatrics and Communicable Diseases

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: February 23, 2021
• Study Start: September 3, 2020
• Primary Completion: January 26, 2023
• Study Completion: April 18, 2023
• Last Updated: December 29, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)