UMIN-CTR Clinical Trial

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
Email	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
Email	mayukowatase@keio.jp

Sponsor
Institute	Keio University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052028