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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04766788
Enrollment
2381
Registered
2021-02-23
Start date
2020-09-03
Completion date
2023-04-18
Last updated
2023-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

Wearable Sensors, students

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.

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.

Sponsors

University of Michigan
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of wearing Fitbit device4 monthsFeasibility will will be defined as wearing the Fitbit watch at least 8 hours per day up to at least 5 days of the week

Secondary

MeasureTime frameDescription
Survey completionUp to 9 monthsCompletion will be measured by the number of participants who complete the study surveys
Saliva sampleUp to 4 monthsAnalyze samples to determine a possible early prediction/detection model for COVID-19
Continuous heart rateUp to 8 monthsAnalyze heart rate data to determine a possible early prediction/detection model for COVID-19
Mental well-beingUp to 9 monthsAssess participant mental well-being during the COVID-19 pandemic and if the use of health and well-being applications impacts self-rated well-being

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026