UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021388 |
|---|---|
| Receipt number | R000024665 |
| Scientific Title | A survey on changes of behavior and attitude of smokers, one year after the complete prohibition against smoking within their workplace. |
| Date of disclosure of the study information | 2016/03/08 |
| Last modified on | 2016/09/09 10:34:09 |
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Basic information
Public title
A survey on changes of behavior and attitude of smokers, one year after the complete prohibition against smoking within their workplace.
Acronym
A survey on changes of behavior and attitude of smokers, one year after the complete prohibition against smoking within their workplace.
Scientific Title
A survey on changes of behavior and attitude of smokers, one year after the complete prohibition against smoking within their workplace.
Scientific Title:Acronym
A survey on changes of behavior and attitude of smokers, one year after the complete prohibition against smoking within their workplace.
Region
| Japan |
Condition
Condition
Smoking
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Surveying changes of the smoking behavior and attitude of smoking employees of Showa University Karasuyama Hospital by the smoke free condition of their workplace, one year after the complete prohibition against smoking within their workplace.
Investigating a contribution level of measuring the concentration of their expired carbon monoxide (COex) to their smoking behavior.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire survey (change of smoking behavior)
Key secondary outcomes
Questionnaire survey (current number of cigarettes per day, time of previous smoking, influencable factor on the change of smoking behavior, contribution of measurement of COex for smoking behavior), COex
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 signed questionnaire and measuring COex (once only).
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
The entrants for the previous clinical 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 (UMIN000016775)", additionally who consented to enter this study in writing.
Key exclusion criteria
Not applicable
Target sample size
32
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
+81-3-3300-5247
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
+81-3-3300-5247
Homepage URL
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
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
| 2016 | Year | 03 | Month | 08 | 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
| 2016 | Year | 03 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 08 | 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=R000024665
