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OpenTrials
Completed

NCT Number: NCT04756869

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Michigan Medicine

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

COVID-19 Monitoring Using Wearable Sensors and Smartphone Technology

Other

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.

Primary outcomes

  1. Feasibility of Wearing Fitbit Watch

    Time frame: 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

    Time frame: 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 outcomes

  1. Survey Completion Rate

    Time frame: 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 outcomes

  1. Clinical Health Outcomes

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 16, 2021
Registry last updated
Feb 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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