UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056078 |
|---|---|
| Receipt number | R000064077 |
| Scientific Title | Intervention Study to Improve Occupational Health and Safety Awareness of Divers Engaged in Underwater Construction |
| Date of disclosure of the study information | 2024/11/06 |
| Last modified on | 2024/11/06 17:09:22 |
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Basic information
Public title
Intervention Study to Improve Occupational Health and Safety Awareness of Divers Engaged in Underwater Construction
Acronym
Intervention Study to Improve Occupational Health and Safety Awareness of Divers Engaged in Underwater Construction
Scientific Title
Intervention Study to Improve Occupational Health and Safety Awareness of Divers Engaged in Underwater Construction
Scientific Title:Acronym
Intervention Study to Improve Occupational Health and Safety Awareness of Divers Engaged in Underwater Construction
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Provide education by watching educational videos to improve diving knowledge and increase safety awareness.
Basic objectives2
Others
Basic objectives -Others
Decrease in occupational accidents
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
validation test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
View educational videos
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
For the following
- Divers belonging to Class I members of the Japan Diving Association (160 establishments)
- All recreational instructors belonging to the 14 diving instruction organizations that make up the Leisure Diving Certification Card Promotion Council
- Consenting parties
Key exclusion criteria
For the following
- Those who have withdrawn their consent
- Those who stopped inputting data in the middle of the process.
- Those who declined in the final screen
Target sample size
1300
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Ishitake |
Organization
Kurume University School of Medicine
Division name
Dept. Environmental Health
Zip code
830-0011
Address
67 Asahimachi, Kurume, Fukuoka, Japan
TEL
0942-31-7552
kankyo@kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Ishitake |
Organization
Kurume University School of Medicine
Division name
Dept. Environmental Health
Zip code
830-0011
Address
67 Asahimachi, Kurume, Fukuoka, Japan
TEL
0942-31-7552
Homepage URL
kankyo@kurume-u.ac.jp
Sponsor or person
Institute
Kurume University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kurume University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kurume University School of Medicine
Address
67 Asahimachi Kurume Fukuoka Japan
Tel
0942-65-3749
i-rinri@kurume-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 06 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2024 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 06 | Day |
Last modified on
| 2024 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064077
