UMIN-CTR Clinical Trial

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

Mental disorder

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Brief Job Stress Questionnaire (BJSQ)

Key secondary outcomes

Work Functioning Impairment Scale (Wfun)
WHO-HPQ

Study type

Interventional

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

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

Ministry Health, Labor and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

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

Date of disclosure of the study information

2017

Year

07

Month

22

Day

URL releasing protocol

Publication of results

Partially published

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

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 related 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