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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028011
Receipt No. R000031683
Scientific Title Prospective study on the effect of smoking prevention measures on smoking cessation including respiratory function test for workers.
Date of disclosure of the study information 2017/07/01
Last modified on 2019/10/31

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Basic information
Public title Prospective study on the effect of smoking prevention measures on smoking cessation including respiratory function test for workers.
Acronym Prospective study on the effect of smoking prevention measures on smoking cessation including respiratory function test for workers.
Scientific Title Prospective study on the effect of smoking prevention measures on smoking cessation including respiratory function test for workers.
Scientific Title:Acronym Prospective study on the effect of smoking prevention measures on smoking cessation including respiratory function test for workers.
Region
Japan Asia(except Japan)

Condition
Condition Not applicable
Adult, Worker
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of the study is to evaluate whether smoking prevention measures including telling lung age will improve smoking rate.
We also aim to examine whether psychologikal distress and work productivity will improve, and sick rate will decrease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes smoking rate
Key secondary outcomes 1)Psychological distress measured by the Brief Job Stress Questionnaire
2)Presenteeism / Absenteeism
3)Physical performance assessments (Hand grip strength, Sit-to-stand test, two-step test)

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 Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 telling lung age obtained by lung function test
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
19 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria Employees who agree to participate in the study with a written informed consent
Key exclusion criteria None
Target sample size 750

Research contact person
Name of lead principal investigator
1st name Makiko
Middle name
Last name Kanai
Organization National Hospital Organization Kyoto Medical Center
Division name Respiratory Medicine
Zip code 6128555
Address 1-1, Fukakusa-Mukaihata-Cho, Fushimi-Ku
TEL 0756419161
Email makiko-kanai@umin.ac.jp

Public contact
Name of contact person
1st name Makiko
Middle name
Last name Kanai
Organization National Hospital Organization Kyoto Medical Center
Division name Respiratory Medicine
Zip code 6128555
Address 1-1, Fukakusa-Mukaihata-Cho, Fushimi-Ku
TEL 0756419161
Homepage URL
Email makiko-kanai@umin.ac.jp

Sponsor
Institute National Hospital Organization Kyoto Medical Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Hospital Organization Kyoto Medical Center
Address 1-1 Mukaihata-cho, Fukakusa, Fushimiku,kyoto citiy
Tel 0756419161
Email makiko-kanai@umin.ac.jp

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
2017 Year 07 Month 01 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
2017 Year 06 Month 29 Day
Date of IRB
2017 Year 07 Month 01 Day
Anticipated trial start date
2017 Year 07 Month 03 Day
Last follow-up date
2019 Year 08 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 30 Day
Last modified on
2019 Year 10 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031683

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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