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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018033
Receipt No. R000020891
Scientific Title A feasibility study of smoking cessation artificial intellgence application for patients with nicotine addiction
Date of disclosure of the study information 2015/06/22
Last modified on 2017/07/13

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Basic information
Public title A feasibility study of smoking cessation artificial intellgence application for patients with nicotine addiction
Acronym A study of smoking cessation application for patients with nicotine addiction
Scientific Title A feasibility study of smoking cessation artificial intellgence application for patients with nicotine addiction
Scientific Title:Acronym A study of smoking cessation application for patients with nicotine addiction
Region
Japan

Condition
Condition nicotine addiction
Classification by specialty
Pneumology Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigate the safety and efficacy of smoking cessation aid application for patients with nicotine addiction.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The normal operation of the application
The safety of the application
Key secondary outcomes

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 Treatment
Type of intervention
Device,equipment
Interventions/Control_1 smoking cessation aid application
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria nicotine addiction patients who entitled to get health care services provided by health insurance and who agree to participate in the study after enough explanation about the study.
Key exclusion criteria exclusion criteria
1. a patient does not agree
2. a patient who the attending physician think is does not seem able to use a smartphone.
3. a patient with severe mental disorder who the attending physician think is not followable in the study.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fukunaga Koichi
Organization Keio University school of medicine
Division name pulmonary devision
Zip code
Address shinanomachi35,shinjyukuku,tokyo
TEL 03-3353-1211
Email k-fuku@jf7.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Fukunaga koichi
Organization Keio University school of medicine
Division name pulmonary devision
Zip code
Address shinanomachi35,shinjyukuku,tokyo
TEL 03-3353-1211
Homepage URL
Email k-fuku@jf7.so-net.ne.jp

Sponsor
Institute Keio University school of medicine pulmonary devision
Institute
Department

Funding Source
Organization CureApp, Inc.
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
Address
Tel
Email

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
2015 Year 06 Month 22 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
2014 Year 12 Month 08 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 06 Month 22 Day
Last modified on
2017 Year 07 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020891

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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