UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028330 |
|---|---|
| Receipt number | R000032424 |
| Scientific Title | Study of the effectiveness for workplace improvements based on stress check program |
| Date of disclosure of the study information | 2017/07/22 |
| Last modified on | 2018/07/23 12:57:41 |
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Basic information
Public title
Study of the effectiveness for workplace improvements based on stress check program
Acronym
Study of the effectiveness for workplace improvements based on stress check program
Scientific Title
Study of the effectiveness for workplace improvements based on stress check program
Scientific Title:Acronym
Study of the effectiveness for workplace improvements based on stress check program
Region
| Japan |
Condition
Condition
Mental disorder
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the idea of improving the workplace environment in the stress check system, we examine the effect of improving workplace environment through intervention survey at model workplace. In particular, qualitatively and quantitatively evaluate the changes of the target workers and organizations, and consider the points of improvement for improving the work environment related to the stress check system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Brief Job Stress Questionnaire (BJSQ)
Key secondary outcomes
Work Functioning Impairment Scale (Wfun)
WHO-HPQ
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Study design is a pre-and post-comparative test that does not have a control group.
In this research, workplace environment improvement method (Yoshikawa et al., 2013) using a participatory approach is conducted at multiple model workplaces in the workplace.
We hold a presentation meeting that will share the improvement results within 1 to 2 months after improvement implementation, and evaluate the effect using the questionnaire before, after, and after the announcement. We also conduct interviews with several workers at the workplace that participated in efforts to improve the workplace environment and perform qualitative assessment on the mental health impact of workplace participation type workplace improvement workplaces while reviewing the process of workplace environment improvement efforts .
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The subjects to be studied are workers.
A workplace that can cooperate with intervention surveys with a set of preliminary questionnaires surveyed according to the procedure of this research, workplace review meeting on workplace environment improvement, workplace environment improvement, achievement presentation meeting, and posterior questionnaire survey Select as "model workplace" to actually conduct intervention research 5 All workers working in the workplace will be subjects of research.
Target workers are included The number of research subjects is about 10 to 30 people. Changes in the workplace organization to which the target person belongs are also planned to be evaluated, and the number of target organizations is assumed to be 5 or less in the workplace.
The setting of the model workplace will utilize the network of members of the research team to publicly invite a workplace that can cooperate with the implementation of workplace environment improvement based on the operation of the stress check system and survey before and after questionnaires.
Specifically, distribute leaflets describing the contents of the initiatives to related research groups and occupational health staff, and recruit model workplaces.
Key exclusion criteria
A worker who receives informed consent to this research and who can not agree to participate
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Yoshikawa |
Organization
National Institute of Occupational Safety and Health, Japan (JNIOSH)
Division name
Research Center for Overwork-Related Disorders (RECORDs)
Zip code
Address
Nagao 6 Chome 21-1, Kawasaki 214-8585 Japan
TEL
044-865-6111(8283)
yoshikawat@jnioshwork.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toru Yoshikawa |
Organization
National Institute of Occupational Safety and Health, Japan (JNIOSH)
Division name
Research Center for Overwork-Related Disorders (RECORDs)
Zip code
Address
Nagao 6 Chome 21-1, Kawasaki 214-8585 Japan
TEL
044-865-6111(8283)
Homepage URL
yoshikawat@jnioshwork.com
Sponsor or person
Institute
National Institute of Occupational Safety and Health, Japan (JNIOSH)
Institute
Department
Personal name
Funding Source
Organization
Ministry Health, Labor 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
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
H2801
Org. issuing International ID_1
National Institute of Occupational Safety and Health, Japan (JNIOSH)
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
独立行政法人労働者安全健康機構労働安全衛生総合研究所
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Main results already published
Date of protocol fixation
| 2016 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 22 | Day |
Last modified on
| 2018 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032424
| Research Plan | |
|---|---|
| Registered date | File name |
| 2018/01/20 | 21-1 様式1 利益相反審査申請書N-G27-04 20160616提出版.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2018/01/20 | 資料２ いきいき職場つくりマニュアル.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2018/01/20 | 資料３ 調査票 名前無し.doc |
Single case data URL
Value
https://center6.umin.ac.jp/ice/32424
