UMIN-CTR Clinical Trial

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