UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020123 |
|---|---|
| Receipt number | R000023245 |
| Scientific Title | A clinical study of smoking cessation application for patients with nicotine addiction |
| Date of disclosure of the study information | 2015/12/09 |
| Last modified on | 2020/08/27 22:52:15 |
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Basic information
Public title
A clinical study of smoking cessation application for patients with nicotine addiction
Acronym
A clinical study of smoking cessation application for patients with nicotine addiction
Scientific Title
A clinical study of smoking cessation application for patients with nicotine addiction
Scientific Title:Acronym
A clinical 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
continuous abstinence rate during 9-24 week
Key secondary outcomes
MPSS(mood and physical symptoms scale), FTCQ-12(12-item French version of the Tobacco Craving Questionnaire),KTSND,continuous abstinence rate during 9-52 week etc
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
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
duration: 6 months
usage: one application per patient
frequency: up to several times daily
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
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Betsuyaku Tomoko |
Organization
Keio University school of medicine
Division name
pulmonary devision
Zip code
Address
shinanomachi35,shinjyukuku,tokyo
TEL
03-3353-1211
tbtsuyaku@z5.keio.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
k-fuku@jf7.so-net.ne.jp
Sponsor or person
Institute
Keio University school of medicine pulmonary devision
Institute
Department
Personal name
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
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 | 12 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://mhealth.jmir.org/2019/2/e12694/
Number of participants that the trial has enrolled
56
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
| 2015 | Year | 12 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 09 | 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 | 12 | Month | 08 | Day |
Last modified on
| 2020 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023245
