Clinical trial NCT05651477: Relationship Between Health Risk and Occupational Exposure of ED
Official title: Establishing a Sub Cohort for Relationship Between Health Risk and Occupational Exposure of Emergency Medical Workers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Occupational Exposure
Occupational Problems
Occupational Burnout
Medical Emergencies
Keywords: Wearable Device
Smart Watch
Internet of Things
IoT
Personal Health Record
PHR
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2022-12-15
Enrollment: 105
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: Medical workers of the emergency department in the tertiary hospitals in Korea

Brief summary: This study established a sub-cohort of emergency medical workers, for the development of health care and disease prevention solution, by identifying epidemiological characteristics and factors related to occupational exposure. Each life-log or environment-log data will be collected by wearable device (e.g. smart-watch) and IoT (e.g. Edge-box). From collected data, relationship between health risks and occupational exposure of emergency medical workers will be determined.

Detailed description: Background : In South Korea, incidence of medical emergency is increasing, and 10 million people are using emergency medical services annually. Emergency medical services, which are directly related to the lives of the people, are essential, but medical staffs engaged in the department are reported to be at high risk due to health-related problems and poor working conditions. Although their general health status is confirmed through periodical health screening, there is a lack of research regarding each really individual health problems.

Objective : This study aims to establish a sub-cohort research system of emergency medical workers to develop disease prevention and health management solutions by identifying relationship between health risk and occupational exposure.

Design : Prospective Observational Cohort Study

Setting : In the Department of Emergency in 5 medical institutions

Enrollment : To be recruited by invitation from the prior cohort (NCT04883684) that consist of 105 doctors or nurses

Data Collection-1 : Life-log data collection by wearable device (smart watch) Participants wear smart watch freely during 12 months. Participants are recommended to wear a watch for at least 10 hours or more a day, and informed it must be worn during work and sleep, while this study assumes wearing a watch without any special intervention in daily life. Participants should access the watch app to transmit the saved data in watch, 2 times a week (Monday and Thursday)

Data Collection-2 : Environment-log data collection by edge-box (TDS Mfepc-4C2R) Among the five institutions where the participants works, Samsung Medical Center collects and manages data by installing 4 edge boxes in emergency medical centers to measure air quality.

Eligibility criteria: Inclusion Criteria:

* An Emergency Medical Worker (doctor, nurse) subject recruited from prior cohort construction studies.
* An adult aged 18 or older, who voluntarily agrees and signs.
* A subject who has not experienced occupational disease or damage within four weeks from the time of establishing a sub-cohort.

Exclusion Criteria:

* An subject who was recruited from prior cohort construction studies, but withdraws the agrees at the time of establishing a sub-cohort
* A subject who does not agree to participate in this study or withdraw the consent after agreement.
* A subject who is not engaged in work, such as leave of absence.
* A subject who has experienced occupational disease or damage within four weeks from the time of establishing a sub-cohort.
* A subject who is legally unable to participate in clinical research or unable to participate in clinical research at the discretion of the investigator.

Primary outcomes:
measure: Some Change Value of Life-log during the Specific Interval
timeFrame: To access the watch app to transmit the saved data in watch, 2 times a week (Monday and Thursday). There is no specific event, but the time frame is transmitted throughout the study period (December 31, 2023).
measure: Some Change Value of Environment-log during the Specific Interval
timeFrame: To transmit the saved data in box, automatically every day. There is no specific event, but the time frame is transmitted throughout the study period (December 31, 2023)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Taerim Kim
role: PRINCIPAL_INVESTIGATOR
References: