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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036401
Receipt No. R000041369
Scientific Title Verification of effectiveness of smoking cessation recommendation in emergency department
Date of disclosure of the study information 2019/06/01
Last modified on 2019/04/03

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Basic information
Public title Verification of effectiveness of smoking cessation recommendation in emergency department
Acronym Verification of effectiveness of smoking cessation recommendation in emergency department
Scientific Title Verification of effectiveness of smoking cessation recommendation in emergency department
Scientific Title:Acronym Verification of effectiveness of smoking cessation recommendation in emergency department
Region
Japan

Condition
Condition smoking
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examine whether it leads to smoking cessation behavior by providing smoking cessation information to smokers who visited emergency outpatients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Whether patients quit smoking after 16 weeks
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Behavior,custom
Interventions/Control_1 Information for smoking cessation outpatient department
Provide information on smoking risks and the benefits of smoking cessation
Questionnaire survey on smoking behavior and intention to quit smoking on the first day and 16 weeks later
Interventions/Control_2 Information for smoking cessation outpatient department
Questionnaire survey on smoking behavior and intention to quit smoking on the first day and 16 weeks later
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
15 years-old <=
Age-upper limit
120 years-old >
Gender Male and Female
Key inclusion criteria registered emergency department
current smoker
discharge patient
Key exclusion criteria No alert patient
No Japanese speaker
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name Tsutomu
Middle name
Last name Iwasaki
Organization St. Luke's International Hospital
Division name Emergency Department
Zip code 104-8560
Address 9-1 Akashi-cho, Chuo-ku, Tokyo
TEL 03-3541-5151
Email iwatsu@luke.ac.jp

Public contact
Name of contact person
1st name Tsutomu
Middle name
Last name Iwasaki
Organization St. Luke's International Hospital
Division name Emergency Department
Zip code 104-8560
Address 9-1 Akashi-cho, Chuo-ku, Tokyo
TEL 03-3541-5151
Homepage URL
Email iwatsu@luke.ac.jp

Sponsor
Institute St. Luke's International Hospital
Institute
Department

Funding Source
Organization St. Luke's International Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization St. Luke's International Hospital
Address 9-1 Akashi-cho, Chuo-ku, Tokyo
Tel 03-3541-5151
Email iwatsu@luke.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 聖路加国際病院

Other administrative information
Date of disclosure of the study information
2019 Year 06 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 Preinitiation
Date of protocol fixation
2019 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 06 Month 01 Day
Last follow-up date
2020 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 04 Month 03 Day
Last modified on
2019 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041369

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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