UMIN-CTR Clinical Trial

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	No longer recruiting
Date of protocol fixation	2019 Year 05 Month 01 Day
Date of IRB	2019 Year 06 Month 19 Day
Anticipated trial start date	2019 Year 07 Month 01 Day
Last follow-up date	2020 Year 06 Month 30 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	2021 Year 04 Month 04 Day

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