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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002973
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Health and Safety
Tokyo Gas CO., LTD
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003608

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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