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OpenTrials
Completed

NCT Number: NCT04766788

Studying Students at Risk for COVID-19

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Michigan Medicine

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of wearing Fitbit device

    Time frame: 4 months

    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

Secondary outcomes

  1. Survey completion

    Time frame: Up to 9 months

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

  2. Saliva sample

    Time frame: Up to 4 months

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

  3. Continuous heart rate

    Time frame: Up to 8 months

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

  4. Mental well-being

    Time frame: Up to 9 months

    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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 23, 2021
Registry last updated
Dec 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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