UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045678 |
|---|---|
| Receipt number | R000052028 |
| Scientific Title | Smoking cessation with smartphone application: real world trial |
| Date of disclosure of the study information | 2021/10/31 |
| Last modified on | 2021/10/06 10:54:26 |
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Basic information
Public title
Smoking cessation with smartphone application: real world trial
Acronym
START
Scientific Title
Smoking cessation with smartphone application: real world trial
Scientific Title:Acronym
START
Region
| Japan |
Condition
Condition
Nicotine dependence
Classification by specialty
| Medicine in general | Pneumology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
CureApp Inc. has received regulatory authorization for the manufacturing the CureApp SC Nicotine Addiction Treatment App and CO Checker (CureApp SC) from the Ministry of Health, Labour and Welfare on 21 August, 2020.
This is the first large real-world trial to evaluate the long efficacy for smoking cessation by using CureApp SC, and to clarify the operational problems.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Continuous abstinence rate (CAR) from weeks 9 to 24
Key secondary outcomes
CAR from weeks 9 to 52
Seven-day point prevalence abstinence rate from weeks 4, 8, 12, 24 and 52
Changes of scores of KTSND; Kano Test for Social Nicotine Dependence, from first visit to weeks 12
KTSND scores at weeks 12
Usage rate of the CureApp SC and its functions: digital diary, a personalized chatbot and smoking cessation educational programs
Weight change
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1. Patients with "nicotine dependence" who are eligible for insurance benefits among patients who visit outpatient clinics for smoking cessation will be covered. In other words, patients must: 1) intend to quit smoking immediately; 2) have a score of 5 or higher on the Tobacco Dependence Screener (hereinafter referred to as TDS), a screening test for nicotine dependence; 3) have a smoking history of 10 Pack-years, if the patient is 35 years old or older; 4) The patient must have given written consent to receive smoking cessation treatment.
2. Age: 20 years or older at the time of obtaining consent
3. Patients who can use a smartphone (OS: Android 5.0 or newer, iPhone 8.0 or newer) (criteria for the CureApp SC group only)
Key exclusion criteria
Patients who do not consent to this study
Target sample size
560
Research contact person
Name of lead principal investigator
| 1st name | Katsunori |
| Middle name | |
| Last name | Masaki |
Organization
Keio University School of Medicine
Division name
Department of Internal Medicine, Division of Pulmonary Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3793
masakik@keio.jp
Public contact
Name of contact person
| 1st name | Mayuko |
| Middle name | |
| Last name | Watase |
Organization
Keio University School of Medicine
Division name
Department of Internal Medicine, Division of Pulmonary Medicine
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3793
Homepage URL
mayukowatase@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Nishikawa Public interest incorporated foundation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee Bureau
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 31 | 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
| 2021 | Year | 09 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing particular
Management information
Registered date
| 2021 | Year | 10 | Month | 06 | Day |
Last modified on
| 2021 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052028
