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

Completed

• Conditions: Covid19
• Interventions: Other: COVID-19 Monitoring Using Wearable Sensors and Smartphone Technology

• Registration Number: NCT04756869
• Lead Sponsor: University of Michigan

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-04-28
• Primary Completion: 2021-01-16
• Study Completion: 2021-01-16
• Study First Submitted: 2021-02-15
• Study First Submitted QC: 2021-02-15
• Study First Posted: 2021-02-16
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-09
• Last Update Posted: 2022-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 226

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Health Care Workers at Risk for COVID-19	COVID-19 Monitoring Using Wearable Sensors and Smartphone Technology	Health care workers at risk for COVID-19 will be monitored using wearing sensors and smartphone technology.

Primary Outcome Measures

Name	Time	Method
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).
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Michigan Medicine; 🇺🇸 Ann Arbor, Michigan, United States