- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05357365
Establishing a Cohort for Occupational Disease of Emergency Medical Workers
November 1, 2022 updated by: Samsung Medical Center
A Study on the Establishment of a Cohort for Occupational Disease, Damage Prevention, and Health Management of Emergency Medical Workers
This study aims to understand the epidemiological characteristics, related factors , and current status of occupational diseases and damage that occur in emergency medical workers (doctors and nurses).
A number of surveys were conducted on about 100 emergency medical workers for about a year with occupational factors, physical health, and mental health.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
Background :
The importance and public role of emergency medical care
- Emergency medical care is a public and essential medical service that is directly related to the lives of the public and plays a key role in the domestic medical delivery system.
Health problems of domestic emergency medical staff
- Emergency medical workers are at higher risk than the general population due to higher work intensity, lack of medical staff, unplanned patient occurrence, and congestion.
- Most emergency medical workers in Korea are classified as high-risk medical staff and receive special medical checkups once or twice a year. On the other hand, these regular medical checkups are only an evaluation of the overall health status of medical staff, which does not lead to prevention before the deterioration of the health status of individual medical staff.
- Objective : The purpose of this study is to establish a cohort research system to develop prevention and health care solutions by identifying epidemiological characteristics, related factors for occupational diseases, and damage occurring in emergency medical workers (doctors and nurses).
- Design: Observational (Cohort study)
- Setting: In the Department of Emergency at the Samsung Medical Center and other hospitals
- Enrollment : About 100 Emergency medical workers (doctors and nurses)
- Methods: Questionnaire surveys on occupational, mental, physical factors during about 1 year.
Study Type
Observational
Enrollment (Actual)
105
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Samsung Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Medical workers of the emergency department in the tertiary hospitals in Korea
Description
Inclusion criteria: The emergency medical workers
- who have heard the explanation of the study and agreed to participate
- aged 18 or older
- have no occupational disease or damage (within 4 weeks) at the time of cohort establishment.
Exclusion criteria:
- Those who disagree with this study
- A person who is not engaged in actual work, such as taking leave of absence, or who does not agree to participate
- Those with occupational diseases or damage at the time of cohort establishment (within 4 weeks)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Doctor
Doctors of the Emergency department conduct questionnaires about occupational, mental, physical factors on their health.
|
Questionnaire survey about occupational, mental, physical factors on one's health.
|
Nurses
Nurses of the Emergency department conduct questionnaires about occupational, mental, physical factors on their health.
|
Questionnaire survey about occupational, mental, physical factors on one's health.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stress_1
Time Frame: At the enrollment
|
Stress of the participants with surveys asking their status
|
At the enrollment
|
Stress_2
Time Frame: 3 months after the enrollment
|
Stress of the participants with surveys asking their status
|
3 months after the enrollment
|
Stress_3
Time Frame: 6 months after the enrollment
|
Stress of the participants with surveys asking their status
|
6 months after the enrollment
|
Stress_4
Time Frame: 9 months after the enrollment
|
Stress of the participants with surveys asking their status
|
9 months after the enrollment
|
Stress_5
Time Frame: 12 months after the enrollment
|
Stress of the participants with surveys asking their status
|
12 months after the enrollment
|
Burn out_1
Time Frame: At the enrollment
|
Burn out of the participants with surveys asking their status
|
At the enrollment
|
Burn out_2
Time Frame: 3 months after the enrollment
|
Burn out of the participants with surveys asking their status
|
3 months after the enrollment
|
Burn out_3
Time Frame: 6 months after the enrollment
|
Burn out of the participants with surveys asking their status
|
6 months after the enrollment
|
Burn out_4
Time Frame: 9 months after the enrollment
|
Burn out of the participants with surveys asking their status
|
9 months after the enrollment
|
Burn out_5
Time Frame: 12 months after the enrollment
|
Burn out of the participants with surveys asking their status
|
12 months after the enrollment
|
Depression_1
Time Frame: At the enrollment
|
Depression of the participants with surveys asking their status
|
At the enrollment
|
Depression_2
Time Frame: 3 months after the enrollment
|
Depression of the participants with surveys asking their status
|
3 months after the enrollment
|
Depression_3
Time Frame: 6 months after the enrollment
|
Depression of the participants with surveys asking their status
|
6 months after the enrollment
|
Depression_4
Time Frame: 9 months after the enrollment
|
Depression of the participants with surveys asking their status
|
9 months after the enrollment
|
Depression_5
Time Frame: 12 months after the enrollment
|
Depression of the participants with surveys asking their status
|
12 months after the enrollment
|
PTSD_1
Time Frame: At the enrollment
|
PTSD of the participants with surveys asking their status
|
At the enrollment
|
PTSD_2
Time Frame: 3 months after the enrollment
|
PTSD of the participants with surveys asking their status
|
3 months after the enrollment
|
PTSD_3
Time Frame: 6 months after the enrollment
|
PTSD of the participants with surveys asking their status
|
6 months after the enrollment
|
PTSD_4
Time Frame: 9 months after the enrollment
|
PTSD of the participants with surveys asking their status
|
9 months after the enrollment
|
PTSD_5
Time Frame: 12 months after the enrollment
|
PTSD of the participants with surveys asking their status
|
12 months after the enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Circulatory mechanical disease_1
Time Frame: At the enrollment
|
Circulatory mechanical disease of the participants with surveys asking their status
|
At the enrollment
|
Circulatory mechanical disease_2
Time Frame: 12 months after the enrollment
|
Circulatory mechanical disease of the participants with surveys asking their status
|
12 months after the enrollment
|
Musculoskeletal disorder_1
Time Frame: At the enrollment
|
Musculoskeletal disorder of the participants with surveys asking their status
|
At the enrollment
|
Musculoskeletal disorder_2
Time Frame: 3 months after the enrollment
|
Musculoskeletal disorder of the participants with surveys asking their status
|
3 months after the enrollment
|
Musculoskeletal disorder_3
Time Frame: 6 months after the enrollment
|
Musculoskeletal disorder of the participants with surveys asking their status
|
6 months after the enrollment
|
Musculoskeletal disorder_4
Time Frame: 9 months after the enrollment
|
Musculoskeletal disorder of the participants with surveys asking their status
|
9 months after the enrollment
|
Musculoskeletal disorder_5
Time Frame: 12 months after the enrollment
|
Musculoskeletal disorder of the participants with surveys asking their status
|
12 months after the enrollment
|
Respiratory disease_1
Time Frame: At the enrollment
|
Respiratory disease of the participants with surveys asking their status
|
At the enrollment
|
Respiratory disease_2
Time Frame: 12 months after the enrollment
|
Respiratory disease of the participants with surveys asking their status
|
12 months after the enrollment
|
Endocrine/metabolic disease_1
Time Frame: At the enrollment
|
Endocrine/metabolic disease of the participants with surveys asking their status
|
At the enrollment
|
Endocrine/metabolic disease_2
Time Frame: 12 months after the enrollment
|
Endocrine/metabolic disease of the participants with surveys asking their status
|
12 months after the enrollment
|
Cancer disease_1
Time Frame: At the enrollment
|
Cancer disease of the participants with surveys asking their status
|
At the enrollment
|
Cancer disease_2
Time Frame: 12 months after the enrollment
|
Cancer disease of the participants with surveys asking their status
|
12 months after the enrollment
|
Other diseases_1
Time Frame: At the enrollment
|
Other diseases of the participants with surveys asking their status
|
At the enrollment
|
Other diseases_2
Time Frame: 12 months after the enrollment
|
Other diseases of the participants with surveys asking their status
|
12 months after the enrollment
|
The change of how good the participants feel about their health condition (very good~very bad) and checking whether they were sick or feel uncomfortable or not (yes vs. no)
Time Frame: Every 2 weeks from the enrollment up to 1 year
|
The change of how good the participants feel about their health condition (very good~very bad) and checking whether they were sick or feel uncomfortable or not (yes vs. no)
|
Every 2 weeks from the enrollment up to 1 year
|
Occupational factors of the participants with surveys: Main working hours_1
Time Frame: At the enrollment
|
Main working hours
|
At the enrollment
|
Occupational factors of the participants with surveys: Main working hours_2
Time Frame: 1 months after the enrollment
|
Main working hours
|
1 months after the enrollment
|
Occupational factors of the participants with surveys: Main working hours_3
Time Frame: 2 months after the enrollment
|
Main working hours
|
2 months after the enrollment
|
Occupational factors of the participants with surveys: Main working hours_4
Time Frame: 3 months after the enrollment
|
Main working hours
|
3 months after the enrollment
|
Occupational factors of the participants with surveys: Main working hours_5
Time Frame: 4 months after the enrollment
|
Main working hours
|
4 months after the enrollment
|
Occupational factors of the participants with surveys: Main working hours_6
Time Frame: 5 months after the enrollment
|
Main working hours
|
5 months after the enrollment
|
Occupational factors of the participants with surveys: Main working hours_7
Time Frame: 6 months after the enrollment
|
Main working hours
|
6 months after the enrollment
|
Occupational factors of the participants with surveys: Main working hours_8
Time Frame: 7 months after the enrollment
|
Main working hours
|
7 months after the enrollment
|
Occupational factors of the participants with surveys: Main working hours_9
Time Frame: 8 months after the enrollment
|
Main working hours
|
8 months after the enrollment
|
Occupational factors of the participants with surveys: Main working hours_10
Time Frame: 9 months after the enrollment
|
Main working hours
|
9 months after the enrollment
|
Occupational factors of the participants with surveys: Main working hours_11
Time Frame: 10 months after the enrollment
|
Main working hours
|
10 months after the enrollment
|
Occupational factors of the participants with surveys: Main working hours_12
Time Frame: 11 months after the enrollment
|
Main working hours
|
11 months after the enrollment
|
Occupational factors of the participants with surveys: Main working hours_13
Time Frame: 12 months after the enrollment
|
Main working hours
|
12 months after the enrollment
|
Occupational factors of the participants with surveys: Average working hours per day_1
Time Frame: At the enrollment
|
Average working hours per day
|
At the enrollment
|
Occupational factors of the participants with surveys: Average working hours per day_2
Time Frame: 1 months after the enrollment
|
Average working hours per day
|
1 months after the enrollment
|
Occupational factors of the participants with surveys: Average working hours per day_3
Time Frame: 2 months after the enrollment
|
Average working hours per day
|
2 months after the enrollment
|
Occupational factors of the participants with surveys: Average working hours per day_4
Time Frame: 3 months after the enrollment
|
Average working hours per day
|
3 months after the enrollment
|
Occupational factors of the participants with surveys: Average working hours per day_5
Time Frame: 4 months after the enrollment
|
Average working hours per day
|
4 months after the enrollment
|
Occupational factors of the participants with surveys: Average working hours per day_6
Time Frame: 5 months after the enrollment
|
Average working hours per day
|
5 months after the enrollment
|
Occupational factors of the participants with surveys: Average working hours per day_7
Time Frame: 6 months after the enrollment
|
Average working hours per day
|
6 months after the enrollment
|
Occupational factors of the participants with surveys: Average working hours per day_8
Time Frame: 7 months after the enrollment
|
Average working hours per day
|
7 months after the enrollment
|
Occupational factors of the participants with surveys: Average working hours per day_9
Time Frame: 8 months after the enrollment
|
Average working hours per day
|
8 months after the enrollment
|
Occupational factors of the participants with surveys: Average working hours per day_10
Time Frame: 9 months after the enrollment
|
Average working hours per day
|
9 months after the enrollment
|
Occupational factors of the participants with surveys: Average working hours per day_11
Time Frame: 10 months after the enrollment
|
Average working hours per day
|
10 months after the enrollment
|
Occupational factors of the participants with surveys: Average working hours per day_12
Time Frame: 11 months after the enrollment
|
Average working hours per day
|
11 months after the enrollment
|
Occupational factors of the participants with surveys: Average working hours per day_13
Time Frame: 12 months after the enrollment
|
Average working hours per day
|
12 months after the enrollment
|
Occupational factors of the participants with surveys: Damages_1
Time Frame: At the enrollment
|
Damages that occurred while performing business operations
|
At the enrollment
|
Occupational factors of the participants with surveys: Damages_2
Time Frame: 3 months after the enrollment
|
Damages that occurred while performing business operations
|
3 months after the enrollment
|
Occupational factors of the participants with surveys: Damages_3
Time Frame: 6 months after the enrollment
|
Damages that occurred while performing business operations
|
6 months after the enrollment
|
Occupational factors of the participants with surveys: Damages_4
Time Frame: 9 months after the enrollment
|
Damages that occurred while performing business operations
|
9 months after the enrollment
|
Occupational factors of the participants with surveys: Damages_5
Time Frame: 12 months after the enrollment
|
Damages that occurred while performing business operations
|
12 months after the enrollment
|
Lifestyle of the participants with surveys: Drinking alcohol status_1
Time Frame: At the enrollment
|
Drinking alcohol status
|
At the enrollment
|
Lifestyle of the participants with surveys: Drinking alcohol status_2
Time Frame: 3 months after the enrollment
|
Drinking alcohol status
|
3 months after the enrollment
|
Lifestyle of the participants with surveys: Drinking alcohol status_3
Time Frame: 6 months after the enrollment
|
Drinking alcohol status
|
6 months after the enrollment
|
Lifestyle of the participants with surveys: Drinking alcohol status_4
Time Frame: 9 months after the enrollment
|
Drinking alcohol status
|
9 months after the enrollment
|
Lifestyle of the participants with surveys: Drinking alcohol status_5
Time Frame: 12 months after the enrollment
|
Drinking alcohol status
|
12 months after the enrollment
|
Lifestyle of the participants with surveys : Smoking_1
Time Frame: At the enrollment
|
Smoking status
|
At the enrollment
|
Lifestyle of the participants with surveys : Smoking_2
Time Frame: 3 months after the enrollment
|
Smoking status
|
3 months after the enrollment
|
Lifestyle of the participants with surveys : Smoking_3
Time Frame: 6 months after the enrollment
|
Smoking status
|
6 months after the enrollment
|
Lifestyle of the participants with surveys : Smoking_4
Time Frame: 9 months up to 1 year
|
Smoking status
|
9 months up to 1 year
|
Lifestyle of the participants with surveys : Smoking_5
Time Frame: 12 months up to 1 year
|
Smoking status
|
12 months up to 1 year
|
Lifestyle of the participants with surveys : Obesity and weight control_1
Time Frame: At the enrollment
|
Status of obesity and weight control
|
At the enrollment
|
Lifestyle of the participants with surveys : Obesity and weight control_2
Time Frame: 3 months after the enrollment
|
Status of obesity and weight control
|
3 months after the enrollment
|
Lifestyle of the participants with surveys : Obesity and weight control_3
Time Frame: 6 months after the enrollment
|
Status of obesity and weight control
|
6 months after the enrollment
|
Lifestyle of the participants with surveys : Obesity and weight control_4
Time Frame: 9 months after the enrollment
|
Status of obesity and weight control
|
9 months after the enrollment
|
Lifestyle of the participants with surveys : Obesity and weight control_5
Time Frame: 12 months after the enrollment
|
Status of obesity and weight control
|
12 months after the enrollment
|
Lifestyle of the participants with surveys: physical activity and exercise_1
Time Frame: At the enrollment
|
Status of physical activity and exercise
|
At the enrollment
|
Lifestyle of the participants with surveys: physical activity and exercise_2
Time Frame: 3 months after the enrollment
|
Status of physical activity and exercise
|
3 months after the enrollment
|
Lifestyle of the participants with surveys: physical activity and exercise_3
Time Frame: 6 months after the enrollment
|
Status of physical activity and exercise
|
6 months after the enrollment
|
Lifestyle of the participants with surveys: physical activity and exercise_4
Time Frame: 9 months after the enrollment
|
Status of physical activity and exercise
|
9 months after the enrollment
|
Lifestyle of the participants with surveys: physical activity and exercise_5
Time Frame: 12 months after the enrollment
|
Status of physical activity and exercise
|
12 months after the enrollment
|
Lifestyle of the participants with surveys : A sense of safety_1
Time Frame: At the enrollment
|
A sense of safety
|
At the enrollment
|
Lifestyle of the participants with surveys : A sense of safety_2
Time Frame: 3 months after the enrollment
|
A sense of safety
|
3 months after the enrollment
|
Lifestyle of the participants with surveys : A sense of safety_3
Time Frame: 6 months after the enrollment
|
A sense of safety
|
6 months after the enrollment
|
Lifestyle of the participants with surveys : A sense of safety_4
Time Frame: 9 months after the enrollment
|
A sense of safety
|
9 months after the enrollment
|
Lifestyle of the participants with surveys : A sense of safety_5
Time Frame: 12 months after the enrollment
|
A sense of safety
|
12 months after the enrollment
|
Lifestyle of the participants with surveys : Stress level_1
Time Frame: At the enrollment
|
Stress level
|
At the enrollment
|
Lifestyle of the participants with surveys : Stress level_2
Time Frame: 3 months after the enrollment
|
Stress level
|
3 months after the enrollment
|
Lifestyle of the participants with surveys : Stress level_3
Time Frame: 6 months after the enrollment
|
Stress level
|
6 months after the enrollment
|
Lifestyle of the participants with surveys : Stress level_4
Time Frame: 9 months after the enrollment
|
Stress level
|
9 months after the enrollment
|
Lifestyle of the participants with surveys : Stress level_5
Time Frame: 12 months after the enrollment
|
Stress level
|
12 months after the enrollment
|
Lifestyle of the participants with surveys: Sleep_1
Time Frame: At the enrollment
|
Sleep
|
At the enrollment
|
Lifestyle of the participants with surveys: Sleep_2
Time Frame: 3 months after the enrollment
|
Sleep
|
3 months after the enrollment
|
Lifestyle of the participants with surveys: Sleep_3
Time Frame: 6 months after the enrollment
|
Sleep
|
6 months after the enrollment
|
Lifestyle of the participants with surveys: Sleep_4
Time Frame: 9 months after the enrollment
|
Sleep
|
9 months after the enrollment
|
Lifestyle of the participants with surveys: Sleep_5
Time Frame: 12 months after the enrollment
|
Sleep
|
12 months after the enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Taerim KIM, Samsung Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 9, 2022
Primary Completion (Anticipated)
May 30, 2023
Study Completion (Anticipated)
December 31, 2023
Study Registration Dates
First Submitted
April 3, 2022
First Submitted That Met QC Criteria
April 27, 2022
First Posted (Actual)
May 2, 2022
Study Record Updates
Last Update Posted (Actual)
November 3, 2022
Last Update Submitted That Met QC Criteria
November 1, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-11-032-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
This is a multicentered study and there are researchers of other institutes, therefore, IPD can be available to them.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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