UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028011 |
|---|---|
| Receipt number | 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 15:09:56 |
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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
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
makiko-kanai@umin.ac.jp
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031683
