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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000028330
Receipt No. 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

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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)
Email 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
Email yoshikawat@jnioshwork.com

Sponsor
Institute National Institute of Occupational Safety and Health, Japan (JNIOSH)
Institute
Department

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
Email

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
URL(English) https://upload.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


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