Relationship Between Health Risk and Occupational Exposure of ED

Occupational Exposure Clinical Trial

Official title:

Establishing a Sub Cohort for Relationship Between Health Risk and Occupational Exposure of Emergency Medical Workers

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05651477
• Other study ID #: 2022-09-044-001
• Status: Enrolling by invitation
• Start date: October 11, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2022
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 105
• Est. completion date: December 31, 2023
• Est. primary completion date: October 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Burnout, Professional
• Emergencies
• Medical Emergencies
• Occupational Burnout
• Occupational Exposure
• Occupational Problems

Intervention

Device:
• Wearable Device (Smart Watch)
A smart watch refers to an embedded system portable watch equipped with improved functions than a general watch, and is almost always in the form of a wrist watch. The device we are using is the Samsung Galaxy 4 (SM-R860/870).
• Edge-Box
Edge-Box collects data such as air. The device we are using is the TDS Mfepc-4C2R.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Some Change Value of Life-log during the Specific Interval	Life-log means a record of an individual's daily life. Participants are recommended to wear a watch for at least 10 hours or more a day during work and sleep, while wearing a watch without any special intervention in daily life.	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).
Primary	Some Change Value of Environment-log during the Specific Interval	Environment-log means a continuous record of a working space, and it mainly measures the air quality.	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)