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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034760
Receipt No. R000039583
Official scientific title of the study Development of CREW (Civility, Respect, Engagement at the workplace) program for workers and research on adaptability in the workplace
Date of disclosure of the study information 2018/12/07
Last modified on 2018/12/08

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Basic information
Official scientific title of the study Development of CREW (Civility, Respect, Engagement at the workplace) program for workers and research on adaptability in the workplace
Title of the study (Brief title) An intervention study of CREW program among workers: a cluster randomized control led study
Region
Japan

Condition
Condition Not applicable
Adult
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the effectiveness of an CREW intervention program for increasing work engagement among workers, with a cluster randomized controlled trial design.
The study also aimed to examine the effectiveness of this program for improving psychological distress, Civility, work performance, Job satisfaction, and organization citizenship behavior.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Work Engagement measured by Utrecht Work Engagement Scale (UWES-9) before randomization, and 3 and 6 months after intervention
Key secondary outcomes 1) Brief Job Stress Questionnaire (BJSQ)
2)Civility (CREW Civility Scale)
3)Work performance measured by WHO Health and Performance Questionnaire (HPQ)
4)Job Job satisfaction (Job satisfaction)
5)Organizational Citizenship Behavior(Organizational Citizenship Behavior)

All outcomes will be measured before randomization, and 3 and 6 months after intervention

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control No treatment
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom Other
Interventions/Control_1 About 15 minutes of CREW program session per session, about 10 times for about 3 months, will be implemented in the group assigned to the intervention group by random assignment. The content of the session is a dialogue in accordance with the theme of the participants. The theme is set for each workplace each time, but be sure to set a theme to think about "respect and respect to each other".
Interventions/Control_2 A facilitator proceeding the session of Intervention 1 is recruited from other than the employee assigned to the non-intervention group. 3 hours of facilitator training will be held for employees who applied for. The content of training consists of "explanation about CREW program", "basic role and principle of facilitator" and "session practice exercise".
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 Employees
Key exclusion criteria None
Target sample size 680

Research contact person
Name of lead principal investigator Utako Sawada
Organization Graduate School of Medicine, The University of Tokyo
Division name Department of Psychiatric Nursing
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL +81358413522
Email utauta-tky@umin.ac.jp

Public contact
Name of contact person Utako Sawada
Organization Graduate School of Medicine, The University of Tokyo
Division name Department of Psychiatric Nursing
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL +81358413522
Homepage URL
Email utauta-tky@umin.ac.jp

Sponsor
Institute Department of Mental Health, Graduate School of Medicine, The University of Tokyo
Institute
Department

Funding Source
Organization Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 日本に所在する企業など (詳細未定)

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 07 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 11 Month 26 Day
Anticipated trial start date
2018 Year 12 Month 01 Day
Last follow-up date
2020 Year 03 Month 20 Day
Date of closure to data entry
2020 Year 03 Month 20 Day
Date trial data considered complete
2020 Year 03 Month 20 Day
Date analysis concluded
2020 Year 03 Month 30 Day

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 11 Month 04 Day
Last modified on
2018 Year 12 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039583

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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