CClinicalTrials.gg
CompletedNCT04766788Updated Dec 29, 2023

Studying Students at Risk for COVID-19

An observational study in Covid19, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-29.

Sponsored by University of Michigan · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,381
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Covid19

Browse trials for

Keywords

  • Wearable Sensors, students
03

In context

COVID-19

7,638 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 2,381 is above the median of 260 across 3,135 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

Exclusion Criteria:

  • Unwilling or unable to comply with the study procedures.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,381 participants (actual)
Patient registry
No

Interventions

  • OtherWearable 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.

06

What researchers measure

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

    Time frame: 4 months

Secondary outcomes

  1. Survey completion

    Completion will be measured by the number of participants who complete the study surveys

    Time frame: Up to 9 months

  2. Saliva sample

    Analyze samples to determine a possible early prediction/detection model for COVID-19

    Time frame: Up to 4 months

  3. Continuous heart rate

    Analyze heart rate data to determine a possible early prediction/detection model for COVID-19

    Time frame: Up to 8 months

  4. 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

    Time frame: Up to 9 months

07

Study locations

1 site
  • Michigan Medicine
    Ann Arbor, Michigan 48109, United States
08

References and documents

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. PubMed 34115607 ↗
  • 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. PubMed 34992051 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04766788
Lead sponsor
University of Michigan
Responsible party
Sung Won Choi (Edith S Briskin and Shirley K Schlafer Foundation Research Professor of Pediatrics and Associate Professor of Pediatrics and Communicable Diseases, University of Michigan) — Principal investigator
First posted
Feb 23, 2021
Start date
Sep 3, 2020
Primary completion
Jan 26, 2023
Completion
Apr 18, 2023
Last update
Dec 29, 2023

Study contacts

Sung Won Choi, MD, MS
principal investigator · University of Michigan

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion