UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015350 |
|---|---|
| Receipt number | R000017856 |
| Scientific Title | Cluster RCT of educational intervention for supervisors on general health for their subordinates |
| Date of disclosure of the study information | 2014/10/07 |
| Last modified on | 2014/10/06 18:11:48 |
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Basic information
Public title
Cluster RCT of educational intervention for supervisors on general health for their subordinates
Acronym
Effects of management education of supervisors for improving general health of their subordinates in occupational health settings: a cluster randomized controlled trial
Scientific Title
Cluster RCT of educational intervention for supervisors on general health for their subordinates
Scientific Title:Acronym
Effects of management education of supervisors for improving general health of their subordinates in occupational health settings: a cluster randomized controlled trial
Region
| Japan |
Condition
Condition
healthy individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine effects of management education for supervisors for improving general health of their subordinates and for improving health-related producticity
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of indicator related to general health at baseline, 3 months, 6 months and 12 months after the start of intervention.
Key secondary outcomes
Change of indicator related to psychosocial work environment, work engagement and health-related productivity at baseline, 3 months, 6 months and 12 months after the start of intervention.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group;
Implementation for supervisors of management education for encouraging their subordinates' successful experiences for a half day. Making the management manuals based on the group discussion and handing out the materials to supervisors.
Interventions/Control_2
Control group;
Routine practice except for questionnaire survey before and after intervention.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Workers in a company
2. Respondents to questionnaire survey
3. Study participants with consent
Key exclusion criteria
1. Workers in the units where the boss had moved just before starting this study
2. Non-Responders to questionnaire survey
3. Study participants without consent
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomohisa Nagata |
Organization
University of Occupational and Environmental Health
Division name
Occupational health practice and management
Zip code
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu Fukuoka, Japan
TEL
+81-93-603-1611
tomohisa@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohisa Nagata |
Organization
University of Occupational and Environmental Health
Division name
Occupational health practice and management
Zip code
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu Fukuoka, Japan
TEL
+81-93-603-1611
Homepage URL
tomohisa@med.uoeh-u.ac.jp
Sponsor or person
Institute
Occupational health practice and management, University of Occupational and Environmental Health
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
産業医科大学 産業生態科学研究所 産業保健経営学研究室
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2015 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 06 | Day |
Last modified on
| 2014 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017856
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
