Covid19NCT04766788
Studying Students at Risk for COVID-19
An observational study of Covid19, run by University of Michigan at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Wearable devices, saliva samples, survey measures
- How many people
- 2,381 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2020to 18 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Students at the University of Michigan must be either coming to campus or reside in the United States.
Who may be able to join
- 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.
Who cannot join
- Unwilling or unable to comply with the study procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Covid19
- Being tested
- Wearable devices, saliva samples, survey measures
- Keywords
- Wearable Sensors, students
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable devices, saliva samples, survey measuresOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 months
Secondary outcomes (4)
Survey completion
Completion will be measured by the number of participants who complete the study surveys
Measured: Up to 9 months
Saliva sample
Analyze samples to determine a possible early prediction/detection model for COVID-19
Measured: Up to 4 months
Continuous heart rate
Analyze heart rate data to determine a possible early prediction/detection model for COVID-19
Measured: 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
Measured: Up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start3 Sep 2020
- Primary completion26 Jan 2023
- Study completion18 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,381 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung Won Choi, University of Michigan
- Investigators
- Sung Won Choi, MD, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766788
- Sponsor's protocol ID
- HUM00185391
- Status last verified
- Dec 2023
- First submitted
- 22 Feb 2021
- Last updated
- 29 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 34115607Gilley 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 34992051Jayaraj 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.
PubMed 39787592
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring Beliefs and Physiological Measures in Students at Risk for COVID-19 Using Wearable Sensors and Smartphone Technology
- ClinicalTrials.gov ID
- NCT04766788
- Acronym / sponsor ID
- HUM00185391
- Conditions
- Covid19
- Keywords
- Wearable Sensors, students
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,381 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 3 Sep 2020 (actual)
- Primary completion
- 26 Jan 2023 (actual)
- Study completion
- 18 Apr 2023 (actual)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Students at the University of Michigan must be either coming to campus or reside in the United States.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Unwilling or unable to comply with the study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable devices, saliva samples, survey measuresProvide a self-collected saliva sample, download and use the suite of apps (e.g., Fitbit, Social Rhythms, Roadmap 2.0), and answer online surveys. | Other | – |
Primary outcome
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
4 secondary outcomes
Survey completion
Time frame: Up to 9 months
Saliva sample
Time frame: Up to 4 months
Continuous heart rate
Time frame: Up to 8 months
Mental well-being
Time frame: Up to 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Background: PubMed 34115607Cislo 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.
- Background: PubMed 34992051Gilley 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.
- Derived from this study: PubMed 39787592Jayaraj 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung Won Choi, MD, MS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of wearing Fitbit device (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04766788, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2023.