UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036401 |
|---|---|
| Receipt number | 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 | 2021/04/04 13:10:34 |
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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
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
iwatsu@luke.ac.jp
Sponsor or person
Institute
St. Luke's International Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041369
