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Studying Students at Risk for COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04766788
Recruitment Status : Active, not recruiting
First Posted : February 23, 2021
Last Update Posted : February 23, 2021
Sponsor:
Information provided by (Responsible Party):
Sung Won Choi, University of Michigan

Brief Summary:
The purpose of this study is to determine whether continuous heart rate obtained from wearable devices and self-reported data from surveys and symptom logs alongside saliva samples can be used to help students self-monitor for infection and eventually be able to create a predictive model to detect infection or illness early.

Condition or disease Intervention/treatment
Covid19 Other: Wearable devices, saliva samples, survey measures

Detailed Description:
During this study, participants will be asked to; Provide a baseline self-collected saliva sample, download and use the suite of apps (e.g., Fitbit, Social Rhythms, Roadmap 2.0) and answer surveys that are delivered through the Roadmap 2.0 app at 4 time points (e.g., baseline, 1-month, 2-month, 3-month [end of academic semester]). You will wear a non-invasive health sensor watch (Fitbit) for up to one academic year and interact with the positive activity and circadian rhythms and fitness apps. We will provide you with "kits" to collect saliva specimens at your home once at baseline. Lastly, you will also take a longer baseline (first) survey and complete an end of month survey regarding your mental well-being (3 total, one each month for a total of 4 months), there will also be an exit survey about your thoughts about COVID-19 and participating in the study at the end of the study.

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Study Type : Observational
Actual Enrollment : 2494 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Monitoring Beliefs and Physiological Measures in Students at Risk for COVID-19 Using Wearable Sensors and Smartphone Technology
Actual Study Start Date : September 3, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : August 2021

Intervention Details:
  • Other: Wearable devices, saliva samples, survey measures
    Provide a baseline self-collected saliva sample, download and use the suite of apps (e.g., Fitbit, Social Rhythms, Roadmap 2.0) and answer surveys that are delivered through the Roadmap 2.0 app at 4 time points (e.g., baseline, 1-month, 2-month, 3-month [end of academic semester]).


Primary Outcome Measures :
  1. Feasibility of wearing Fitbit device [ Time Frame: 9 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 over the period of an academic semester


Secondary Outcome Measures :
  1. Survey completion [ Time Frame: 4 months ]
    Completion will be measured by the number of participants who complete baseline survey and monthly surveys.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Students at the University of Michigan who have moved back to Ann Arbor or who are completing schooling completely online.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04766788


Locations
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United States, Michigan
Michigan Medicine
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Sung Choi, MS, MD University of Michigan
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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
ClinicalTrials.gov Identifier: NCT04766788    
Other Study ID Numbers: HUM00185391
First Posted: February 23, 2021    Key Record Dates
Last Update Posted: February 23, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sung Won Choi, University of Michigan:
Wearable Sensors, students