Studying Students at Risk for COVID-19

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04766788
• Other study ID #: HUM00185391
• Status: Completed
• Start date: September 3, 2020
• Est. completion date: April 18, 2023

Study information

• Verified date: December 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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, 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2381
• Est. completion date: April 18, 2023
• Est. primary completion date: January 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Other:
• Wearable 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.

Locations

Country	Name	City	State
United States	Michigan Medicine	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 months
Secondary	Survey completion	Completion will be measured by the number of participants who complete the study surveys	Up to 9 months
Secondary	Saliva sample	Analyze samples to determine a possible early prediction/detection model for COVID-19	Up to 4 months
Secondary	Continuous heart rate	Analyze heart rate data to determine a possible early prediction/detection model for COVID-19	Up to 8 months
Secondary	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	Up to 9 months