UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034760 |
|---|---|
| Receipt number | R000039583 |
| Scientific Title | 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 | 2023/05/09 14:13:10 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development of CREW (Civility, Respect, Engagement at the workplace) program for workers and research on adaptability in the workplace
Acronym
An intervention study of CREW program among workers: a cluster randomized control led study
Scientific Title
Development of CREW (Civility, Respect, Engagement at the workplace) program for workers and research on adaptability in the workplace
Scientific Title:Acronym
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) 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
| 1st name | Utako |
| Middle name | |
| Last name | Sawada |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Psychiatric Nursing
Zip code
1130033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
0358413584
utauta-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Utako |
| Middle name | |
| Last name | Sawada |
Organization
The University of Tokyo
Division name
Department of Psychiatric Nursing
Zip code
1130033
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
0358413584
Homepage URL
utauta-tky@umin.ac.jp
Sponsor or person
Institute
Department of Mental Health, Graduate School of Medicine, The University of Tokyo
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Graduate School of Medicine, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
Tel
0358413584
ethics@m.u-tokyo.ac.jp
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
342
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Because the analysis is in progress.
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
| 2018 | Year | 11 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 05 | 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
| 2025 | Year | 03 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 04 | Day |
Last modified on
| 2023 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.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 |
