UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000031620
Receipt No. R000035975
Scientific Title A randomized controlled trial of telecare and face to face consultation with CA-F17 based on the standard smoking cessation program for nicotine dependence.
Date of disclosure of the study information 2018/03/08
Last modified on 2019/09/03 (Ver. 5)

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Basic information
Public title A randomized controlled trial of telecare and face to face consultation with CA-F17 based on the standard smoking cessation program for nicotine dependence.
Acronym A randomized controlled trial of telecare and face to face consultation with CA-F17 based on the standard smoking cessation program for nicotine dependence.
Scientific Title A randomized controlled trial of telecare and face to face consultation with CA-F17 based on the standard smoking cessation program for nicotine dependence.
Scientific Title:Acronym A randomized controlled trial of telecare and face to face consultation with CA-F17 based on the standard smoking cessation program for nicotine dependence.
Region
Japan

Condition
Condition nicotine dependence
Classification by specialty
Medicine in general Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Randomized, controlled non-inferiority study to assess the efficacy and safety of CA-F17 using telecommunications technology in addition to the standard smoking cessation treatment program as compared with face to face consultation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 9-12 week Continuous Abstinence Rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Behavior,custom
Interventions/Control_1 Intervention group:One-time dispense of CA-F17 in conjunction with 3months of Standard Treatment of Nicotine Dependence using telecommunications technology.
Interventions/Control_2 Control group:One-time dispense of CA-F17 in conjunction with 3 months of Standard Treatment of Nicotine Dependence with face to face consultation.
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 Cases using a smartphone, diagnosed as nicotine dependent on tobacco dependence screening test who intend to quit smoking immediately
Key exclusion criteria Cases judged difficult to participate in the trial, such as severe mental illness
Target sample size 114

Research contact person
Name of lead principal investigator
1st name Akihiro
Middle name
Last name Nomura
Organization Kanazawa University Hospital
Division name Innovative Research Center
Zip code 9200934
Address 13-1,Takaramachi, Kanazawa city, Ishikawa prefecture
TEL 076-265-2049
Email anomura@med.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name Tomoyasu
Middle name
Last name Muto
Organization CureApp, Inc.
Division name Clinical and Regulatory Affairs Department
Zip code 1030001
Address 12-5, Kodenmacho, Nihombashi, Chu-o-ku, Tokyo
TEL 03-6231-0183
Homepage URL
Email clinreg_admin@cureapp.jp

Sponsor
Institute CureApp, Inc.
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 Tokyo-Eki Center-building Clinic Institutional Review Board
Address 3-3-14, Nihombashi, Chuo-ku, Tokyo, 103-0027, Japan
Tel 03-1526-6688
Email info_tecc-irb@clinipro.co.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
2018 Year 03 Month 08 Day

Related information
URL releasing protocol https://www.researchprotocols.org/2019/7/e12701/
Publication of results Published

Result
URL related to results and publications https://www.jmir.org/2019/4/e13520/
Number of participants that the trial has enrolled 115
Results 
We randomized 115 participants with nicotine dependence: 58 were allocated to the telemedicine (internet-based video counseling) arm and 57, to the control (standard face-to-face clinical visit) arm. We analyzed all 115 participants for the primary outcome. Both telemedicine and control groups had similar CARs from weeks 9 to 12 (81.0% vs 78.9%; absolute difference, 2.1%; 95% CI -12.8 to 17.0), and the lower limit of the difference between groups (-12.8%) was greater than the prespecified limit (-15%).
Results date posted
2019 Year 09 Month 03 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2019 Year 01 Month 28 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 03 Month 08 Day
Date of IRB
2018 Year 03 Month 09 Day
Anticipated trial start date
2018 Year 03 Month 12 Day
Last follow-up date
2018 Year 12 Month 05 Day
Date of closure to data entry
2018 Year 12 Month 14 Day
Date trial data considered complete
2019 Year 01 Month 15 Day
Date analysis concluded
2019 Year 01 Month 17 Day

Other
Other related information

Management information
Registered date
2018 Year 03 Month 07 Day
Last modified on
2019 Year 09 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035975