Clinical trial NCT04756869: Monitoring Health Care Workers at Risk for COVID-19 Using Wearable Sensors and Smartphone Technology
Official title: Monitoring Health Care Workers at Risk for COVID-19 Using Wearable Sensors and Smartphone Technology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: mobile health
wearable sensors
COVID-19
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health care workers at Michigan Medicine at risk for COVID-19

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of Wearing Fitbit Watch
timeFrame: 30 days
measure: Feasibility of Wearing TempTraq Patch
timeFrame: 30 days
Secondary outcomes:
measure: Survey Completion Rate
timeFrame: 30 days
Other outcomes:
measure: Clinical Health Outcomes
timeFrame: 2 years
Locations:
city: Ann Arbor
country: United States
facility: Michigan Medicine
state: Michigan
Study officials:
affiliation: University of Michigan
name: Sung Choi, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.