TY  - JOUR
AU  - Nomura, Akihiro
AU  - Tanigawa, Tomoyuki
AU  - Muto, Tomoyasu
AU  - Oga, Takafumi
AU  - Fukushima, Yasushi
AU  - Kiyosue, Arihiro
AU  - Miyazaki, Masaki
AU  - Hida, Eisuke
AU  - Satake, Kohta
PY  - 2019
DA  - 2019/04/26
TI  - Clinical Efficacy of Telemedicine Compared to Face-to-Face Clinic Visits for Smoking Cessation: Multicenter Open-Label Randomized Controlled Noninferiority Trial
JO  - J Med Internet Res
SP  - e13520
VL  - 21
IS  - 4
KW  - smoking cessation
KW  - nicotine dependence
KW  - telecare
KW  - telemedicine
KW  - mHealth
KW  - digital therapeutics
KW  - mobile phone
AB  - Background: Tobacco is a major public health concern. A 12-week standard smoking cessation program is available in Japan; however, it requires face-to-face clinic visits, which has been one of the key obstacles to completing the program, leading to a low smoking cessation success rate. Telemedicine using internet-based video counseling instead of regular clinic visits could address this obstacle. Objective: This study aimed to evaluate the efficacy and feasibility of an internet-based remote smoking cessation support program compared with the standard face-to-face clinical visit program among patients with nicotine dependence. Methods: This study was a randomized, controlled, open-label, multicenter, noninferiority trial. We recruited nicotine-dependent adults from March to June 2018. Participants randomized to the telemedicine arm received internet-based video counseling, whereas control participants received standard face-to-face clinic visits at each time point in the smoking cessation program. Both arms received a CureApp Smoking Cessation smartphone app with a mobile exhaled carbon monoxide checker. The primary outcome was a continuous abstinence rate (CAR) from weeks 9 to 12. Full analysis set was used for data analysis. 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%). Conclusions: The application of telemedicine using internet-based video counseling as a smoking cessation program had a similar CAR from weeks 9 to 12 as that of the standard face-to-face clinical visit program. The efficacy of the telemedicine-based smoking cessation program was not inferior to that of the standard visit–based smoking cessation program. Trial Registration: University Hospital Medical Information Network Clinical Trials Registry: UMIN000031620; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035975. 
SN  - 1438-8871
UR  - http://www.jmir.org/2019/4/e13520/
UR  - https://doi.org/10.2196/13520
UR  - http://www.ncbi.nlm.nih.gov/pubmed/30982776
DO  - 10.2196/13520
ID  - info:doi/10.2196/13520
ER  -