Monitoring Health Care Workers at Risk for COVID-19 Using Wearable Sensors and Smartphone Technology

Sponsor
University of Michigan (Other)
Overall Status
Completed
CT.gov ID
NCT04756869
Collaborator
(none)
226
1
8.6
26.2

Study Details

Study Description

Brief Summary

This prospective study of health care workers utilizes wearable sensors, surveys and symptom logs, and biospecimens in an effort to improve self-monitoring practices for COVID-19 among health care workers and to provide key data for the development of a predictive model for early detection of COVID-19 infection.

Condition or Disease Intervention/Treatment Phase
  • Other: COVID-19 Monitoring Using Wearable Sensors and Smartphone Technology

Detailed Description

Health care workers work on the front lines of the COVID-19 pandemic, so early detection of COVID-19 infection is especially important in this population in order to prevent the spread of disease among the health care workforce, their patients, and their families. However, standard symptomatic COVID-19 testing is insufficient to protect health care workers and prevent the spread of disease. This study utilizes continuous physiological data from wearable sensors and surveys completed via smartphone technology, in conjunction with biospecimens, in order to assist health care workers in their self-monitoring for COVID-19 infection. Subjects will wear smart watches and temperature monitoring patches to collect continuous heart rate and temperature data. Subjects will also complete baseline and exit surveys, in addition to daily mood and symptom logging surveys. Finally, subjects will provide biospecimens - nasal and saliva samples and optional blood samples. Using wearable sensor data in conjunction with survey data and biospecimens, this study aims to prevent the spread of COVID-19 among health care workers, their patients, and their families, and to eventually develop a predictive model for early detection of COVID-19 infection.

Study Design

Study Type:
Observational
Actual Enrollment :
226 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Monitoring Health Care Workers at Risk for COVID-19 Using Wearable Sensors and Smartphone Technology
Actual Study Start Date :
Apr 28, 2020
Actual Primary Completion Date :
Jan 16, 2021
Actual Study Completion Date :
Jan 16, 2021

Arms and Interventions

Arm Intervention/Treatment
Health Care Workers at Risk for COVID-19

Health care workers at risk for COVID-19 will be monitored using wearing sensors and smartphone technology.

Other: COVID-19 Monitoring Using Wearable Sensors and Smartphone Technology
Health care workers are on-study for 30 days, in which they wear a smart watch and temperature patches up to daily. Subjects also may provide nasal and saliva samples up to daily during the study period, and they may opt-in to blood samples lasting up to 1 year after study completion. Through a smartphone app, participants complete surveys at baseline and at study completion, as well as daily mood surveys and symptom-reporting surveys. Finally, exit interviews occur at the end of the study period, and follow-up interviews may occur at specified timepoints up to 1 year after study completion.

Outcome Measures

Primary Outcome Measures

  1. Feasibility of Wearing Fitbit Watch [30 days]

    Feasibility is defined as wearing the Fitbit Watch for at least 8 hours a day, 5 days a week (~40 hours/week or 160 hours/30 days).

  2. Feasibility of Wearing TempTraq Patch [30 days]

    Feasibility is defined as wearing the TempTraq for at least 8 hours a day, five days a week (~40 hours/week or 160 hours/30 days).

Secondary Outcome Measures

  1. Survey Completion Rate [30 days]

    This outcome is measured by the percentage of subjects that complete their surveys, estimating that at least 50% of subjects will complete the baseline and exit surveys, and at least 50% of subjects will complete at least 50% of the daily symptom surveys.

Other Outcome Measures

  1. Clinical Health Outcomes [2 years]

    Detection of SARS-CoV-2 using any of the following: biospecimens, self-reported test results, a database of COVID-19 testing and results maintained in Employee Health at Michigan Medicine, and subjects' electronic medical records

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Adult Michigan Medicine health care workers age 18 years and older.

  • Health care workers who are involved in direct (in-person) face-to-face patient care or health care workers who are not involved in direct (in-person) face-to-face patient care but work on units where COVID-19 patients are/will likely be treated.

  • Possession of a smartphone (Apple or Android).

  • Ability to understand and demonstrate willingness to remotely sign a written informed consent.

Exclusion Criteria:
  • Unwilling or unable to comply with the study procedures or to allow the study team access to health data.

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, MD, MS, 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:
NCT04756869
Other Study ID Numbers:
  • HUM00180076
First Posted:
Feb 16, 2021
Last Update Posted:
Feb 11, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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 Feb 11, 2022