UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002973 |
|---|---|
| Receipt number | R000003608 |
| Scientific Title | Efficacy of preventive education on eye-nose-mouth hygiene and hand hygiene for influenza-like illness -Cluster controlled trial in workplace- |
| Date of disclosure of the study information | 2010/01/05 |
| Last modified on | 2013/06/25 17:35:52 |
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Basic information
Public title
Efficacy of preventive education on eye-nose-mouth hygiene and hand hygiene for influenza-like illness
-Cluster controlled trial in workplace-
Acronym
Preventive education on eye-nose-mouth hygiene and hand hygiene for influenza-like illness
-Cluster controlled trial in workplace-
Scientific Title
Efficacy of preventive education on eye-nose-mouth hygiene and hand hygiene for influenza-like illness
-Cluster controlled trial in workplace-
Scientific Title:Acronym
Preventive education on eye-nose-mouth hygiene and hand hygiene for influenza-like illness
-Cluster controlled trial in workplace-
Region
| Japan |
Condition
Condition
Influenza-like illness
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare and evaluate the efficacy of preventive education (education about eye-nose-mouth hygiene, hand hygiene, gargling) for influenza-like illness in the workplace
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
influenza-like illness occurrence during 8 weeks and 6 months after starting preventive education (education on eye-nose-mouth hygiene, education on hand hygiene or
general education)
Key secondary outcomes
questionnaire result about preventive actions for influenza-like illness
(before and after the intervention)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Group 1:eye-nose-mouth hygiene education group
Educate group members about how to prevent the transmission of influenza by eye-nose-mouth hygiene using Check Sheets and Posters.
Group members use Check Sheets for 8 weeks.
Contents of the Check Sheet:
1.Information of influenza
2.Preventive Action:
A. Don't touch eyes, nose or mouth.
B. Wash hands before touching eyes, nose or mouth.
3.Checklist: Members check the degree of preventive actions and influenza-like illness symptoms everyday.
Interventions/Control_2
Group 2:hand hygiene education group
Educate group members about how to prevent the transmission of influenza by hand hygiene using Check Sheets and Posters.
Group members use Check Sheets for 8 weeks.
Contents of the Check Sheet:
1.Information of influenza
2.Preventive Action:
Wash hands frequently.
3.Checklist: Members check the degree of preventive actions and influenza-like illness symptoms everyday.
Interventions/Control_3
Group 3:general education group
Educate group members about how to prevent the transmission of influenza by hand hygiene and gargling using Check Sheets and Posters.
Group members use Check Sheets for 8 weeks.
Contents of the Check Sheet:
1.Information of influenza
2.Preventive Action:
A. Wash hands.
B. Gargle.
3.Checklist: Members check the degree of preventive actions and influenza-like illness symptoms everyday.
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
all workers who belong to 4 kinds of departments in 9 establishments
Key exclusion criteria
all workers who are out of work on October 1st, 2009
Target sample size
1400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fukunaka Yasushi |
Organization
Tokyo Gas CO., LTD
Division name
Department of Health and Safety
Zip code
Address
1-5-20, Kaigan Minato-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Fukunaka Yasushi |
Organization
Tokyo Gas CO., LTD
Division name
Department of Health and Safety
Zip code
Address
1-5-20, Kaigan Minato-ku, Tokyo
TEL
Homepage URL
Sponsor or person
Institute
Department of Health and Safety
Tokyo Gas CO., LTD
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
東京ガス株式会社
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 01 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
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
Completed
Date of protocol fixation
| 2009 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2010 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 01 | Month | 05 | Day |
Last modified on
| 2013 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003608
