UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043216 |
|---|---|
| Receipt number | R000046713 |
| Scientific Title | Observational study on physicians who work extended hours in association with their physical and mental health |
| Date of disclosure of the study information | 2021/02/02 |
| Last modified on | 2024/08/05 10:16:08 |
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Basic information
Public title
Physicians' working reformation: a national survey
Acronym
Physicians' working reformation: a national survey
Scientific Title
Observational study on physicians who work extended hours in association with their physical and mental health
Scientific Title:Acronym
Study on long-working physicians
Region
| Japan |
Condition
Condition
physical and mental condition
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish and assess both subjective and objective measures of the physical and mental health status of physicians who work extended hours.
Basic objectives2
Others
Basic objectives -Others
To establish and assess both subjective and objective measures of the physical and mental health status of physicians who work extended hours.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Depression
Key secondary outcomes
Sleepiness and alertness
Burnout
Fatigueness
Physical conditions and social events that relate to the above mentioned condition.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Those physicians working in Japan who participated and gave consent of participation in the study
Key exclusion criteria
None
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Tanigawa |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Public Health
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111ext3535
tataniga@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Hiroo |
| Middle name | |
| Last name | Wada |
Organization
Juntendo University Graduate School of Medicine
Division name
Department of Public Health
Zip code
113-8421
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111ext3535
Homepage URL
https://www.juntendo.ac.jp/graduate/laboratory/labo/kosyu_eisei/k2.html
h-wada@juntendo.ac.jp
Sponsor or person
Institute
Department of Public Health, Juntendo University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board of Juntendo University Faculty of Medicine
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-3813-3111
N/A
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
| 2021 | Year | 02 | Month | 02 | 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
| 2020 | Year | 06 | Month | 30 | Day |
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research Design
-National Data
-Observational studies
How to recruit research subjects
Approximately 140,000 physicians working in health care facilities across the country were recruited by mail and email.
Management information
Registered date
| 2021 | Year | 02 | Month | 01 | Day |
Last modified on
| 2024 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046713
