UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031620 |
|---|---|
| Receipt number | 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 16:04:45 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
clinreg_admin@cureapp.jp
Sponsor or person
Institute
CureApp, Inc.
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
Tokyo-Eki Center-building Clinic Institutional Review Board
Address
3-3-14, Nihombashi, Chuo-ku, Tokyo, 103-0027, Japan
Tel
03-1526-6688
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035975
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
