UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016775
Receipt number 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 10:33:29

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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 or person

Institute

Showa University Clinical Research Institute for Clinical Pharmacology and Therapeutics

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019468