UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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	Tatsunori Suzuki
Organization	Showa University Clinical Research Institute for Clinical Pharmacology and Therapeutics
Division name	Not applicable
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	Tatsunori Suzuki
Organization	Showa University Clinical Research Institute for Clinical Pharmacology and Therapeutics
Division name	Not applicable
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000019468