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

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 226

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Michigan Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Health care workers at Michigan Medicine at risk for COVID-19

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Wearing Fitbit Watch	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).	30 days
Feasibility of Wearing TempTraq Patch	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).	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survey Completion Rate	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.	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Health Outcomes	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	2 years

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Clingan CA, Dittakavi M, Rozwadowski M, Gilley KN, Cislo CR, Barabas J, Sandford E, Olesnavich M, Flora C, Tyler J, Mayer C, Stoneman E, Braun T, Forger DB, Tewari M, Choi SW. Monitoring Health Care Workers at Risk for COVID-19 Using Wearable Sensors and Smartphone Technology: Protocol for an Observational mHealth Study. JMIR Res Protoc. 2021 May 12;10(5):e29562. doi: 10.2196/29562.

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2020
• Primary Completion (Actual): January 16, 2021
• Study Completion (Actual): January 16, 2021

Study Registration Dates

• First Submitted: February 15, 2021
• First Submitted That Met QC Criteria: February 15, 2021
• First Posted (Actual): February 16, 2021

Study Record Updates

• Last Update Posted (Actual): February 11, 2022
• Last Update Submitted That Met QC Criteria: February 9, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: mobile health; COVID-19; wearable sensors
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: HUM00180076

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data (IPD) will be shared with other researchers when the appropriate Data Use Agreement (DUA) is in place. What IPD will be shared is undecided at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No