Occupational ExposureNCT05651477
Relationship Between Health Risk and Occupational Exposure of ED
An observational study of Occupational Exposure and Occupational Problems, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Occupational Exposure, Occupational Problems, Occupational Burnout
- What is being tested?
- Wearable Device (Smart Watch) and Edge-Box
- Type of treatment
- Medical device
- How many people
- 105 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 Oct 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Medical workers of the emergency department in the tertiary hospitals in Korea
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Establishing a Sub Cohort for Relationship Between Health Risk and Occupational Exposure of Emergency Medical Workers
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.
Read the 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.
- Being tested
- Wearable Device (Smart Watch), Edge-Box
- Keywords
- Wearable Device, Smart Watch, Internet of Things, IoT, Personal Health Record, PHR
- Medical subject headings
- Burnout, Professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable Device (Smart Watch)Device
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-BoxDevice
Edge-Box collects data such as air. The device we are using is the TDS Mfepc-4C2R.
| Study group | Role | What they receive |
|---|---|---|
| Doctor | Doctors of the Emergency department conduct questionnaires about occupational, mental, physical factors on their health. Receives: Device: Wearable Device (Smart Watch); Device: Edge-Box | |
| Nurses | Nurses of the Emergency department conduct questionnaires about occupational, mental, physical factors on their health. Receives: Device: Wearable Device (Smart Watch); Device: Edge-Box |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start11 Oct 2022
- Primary completion10 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational ExposureStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Taerim Kim, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651477
- Sponsor's protocol ID
- 2022-09-044-001
- Status last verified
- Oct 2022
- First submitted
- 30 Oct 2022
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This is a multicentered study and there are researchers of other institutes, therefore, IPD can be available to them.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing a Sub Cohort for Relationship Between Health Risk and Occupational Exposure of Emergency Medical Workers
- ClinicalTrials.gov ID
- NCT05651477
- Acronym / sponsor ID
- 2022-09-044-001
- Keywords
- Wearable Device, Smart Watch, Internet of Things, IoT, Personal Health Record, PHR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 11 Oct 2022 (actual)
- Primary completion
- 10 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 15 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doctor | – | Device: Wearable Device (Smart Watch), Device: Edge-BoxDoctors of the Emergency department conduct questionnaires about occupational, mental, physical factors on their health. |
| Nurses | – | Device: Wearable Device (Smart Watch), Device: Edge-BoxNurses of the Emergency department conduct questionnaires about occupational, mental, physical factors on their health. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Medical workers of the emergency department in the tertiary hospitals in Korea
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | Doctor, Nurses |
| Edge-BoxEdge-Box collects data such as air. The device we are using is the TDS Mfepc-4C2R. | Device | Doctor, Nurses |
Primary outcome
Some Change Value of Life-log during the Specific Interval
Time frame: 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).
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.
Some Change Value of Environment-log during the Specific Interval
Time frame: 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)
Environment-log means a continuous record of a working space, and it mainly measures the air quality.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Individual participant dataSharing planned: Undecided. This is a multicentered study and there are researchers of other institutes, therefore, IPD can be available to them.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Taerim Kim principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Occupational Exposure and Occupational Problems, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Some Change Value of Life-log during the Specific Interval (time frame: 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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.