Studying Students at Risk for COVID-19

Sponsor
University of Michigan (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04766788
Collaborator
(none)
2,494
1
57.9
43.1

Study Details

Study Description

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 Phase
  • 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]). The participant 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. The investigator will provide the participants with "kits" to collect saliva specimens at their home once at baseline. Lastly, the participant will also take a longer baseline (first) survey and complete an end of month survey regarding their mental well-being (3 total, one each month for a total of 4 months), there will also be an exit survey about their thoughts about COVID-19 and participating in the study at the end of the study.

Study Design

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 :
Sep 3, 2020
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 1, 2025

Outcome Measures

Primary Outcome Measures

  1. Feasibility of wearing Fitbit device [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 [4 months]

    Completion will be measured by the number of participants who complete baseline survey and monthly surveys.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Michigan Medicine Ann Arbor Michigan United States 48109

Sponsors and Collaborators

  • University of Michigan

Investigators

  • Principal Investigator: Sung Choi, MS, MD, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Feb 23, 2021
Last Update Posted:
Jan 13, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by 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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 13, 2022