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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016775
Receipt No. R000019468
Scientific Title A survey on changes of behavior and attitude of smokers after the complete prohibition against smoking within their workplace and the measurement of the concentration of expired carbon monoxide.
Date of disclosure of the study information 2015/03/11
Last modified on 2016/09/09

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Basic information
Public title A survey on changes of behavior and attitude of smokers after the complete prohibition against smoking within their workplace and the measurement of the concentration of expired carbon monoxide.
Acronym A survey on changes of behavior and attitude of smokers after the complete prohibition against smoking within their workplace and the measurement of expired pCO.
Scientific Title A survey on changes of behavior and attitude of smokers after the complete prohibition against smoking within their workplace and the measurement of the concentration of expired carbon monoxide.
Scientific Title:Acronym A survey on changes of behavior and attitude of smokers after the complete prohibition against smoking within their workplace and the measurement of expired pCO.
Region
Japan

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

Objectives
Narrative objectives1 Measuring the concentration of expired carbon monoxide (expired pCO) of smoking employees of Showa University Karasuyama Hospital.
Surveying the comprehension about the influence on physical condition by smoking, and changes of the attitude toward smoking after they noticed the level of expired pCO.
Moreover, investigating changes of the smoking behavior, attitude and expired pCO by the complete smoke free condition of their workplace and by the measurement of expired pCO secondary, in the following surveys.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Questionnaire survey (age, gender, smoking history, current number of cigarettes per day, time of previous smoking), expired pCO, degree of comprehension about influence on physical condition by smoking
Key secondary outcomes Questionnaire survey (change of smoking behavior, influencable factor on the change of smoking behavior), contribution of measurement of expired pCO for smoking behavior

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Answering the unsigned questionnaire and measuring expired pCO, and then taking the following surveys (answering the signed questionnaire and measuring expired pCO) in 1, 3 and 6 months.
Interventions/Control_2
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 Smoking employees of Showa University Karasuyama Hospital who accepted answering the unsigned questionnaire and measuring expired pCO, additionally who consented to advancing toward the following surveys in writing.
Key exclusion criteria Not applicable
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsunori Suzuki
Organization Showa University Clinical Research Institute for Clinical Pharmacology and Therapeutics
Division name Not applicable
Zip code
Address 6-11-11 Kitakarasuyama Setagaya-ku Tokyo 157-8577, JAPAN
TEL 03-3300-5247
Email tatsunori@med.showa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsunori Suzuki
Organization Showa University Clinical Research Institute for Clinical Pharmacology and Therapeutics
Division name Not applicable
Zip code
Address 6-11-11 Kitakarasuyama Setagaya-ku Tokyo 157-8577, JAPAN
TEL 03-3300-5247
Homepage URL
Email tatsunori@med.showa-u.ac.jp

Sponsor
Institute Showa University Clinical Research Institute for Clinical Pharmacology and Therapeutics
Institute
Department

Funding Source
Organization Showa University Clinical Research Institute for Clinical Pharmacology and Therapeutics
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

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 11 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 Completed
Date of protocol fixation
2015 Year 02 Month 27 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 11 Day
Last follow-up date
2015 Year 10 Month 02 Day
Date of closure to data entry
2015 Year 12 Month 31 Day
Date trial data considered complete
2015 Year 12 Month 31 Day
Date analysis concluded
2015 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 03 Month 11 Day
Last modified on
2016 Year 09 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019468

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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