@Article{info:doi/10.2196/13520,
author="Nomura, Akihiro
and Tanigawa, Tomoyuki
and Muto, Tomoyasu
and Oga, Takafumi
and Fukushima, Yasushi
and Kiyosue, Arihiro
and Miyazaki, Masaki
and Hida, Eisuke
and Satake, Kohta",
title="Clinical Efficacy of Telemedicine Compared to Face-to-Face Clinic Visits for Smoking Cessation: Multicenter Open-Label Randomized Controlled Noninferiority Trial",
journal="J Med Internet Res",
year="2019",
month="Apr",
day="26",
volume="21",
number="4",
pages="e13520",
keywords="smoking cessation; nicotine dependence; telecare; telemedicine; mHealth; digital therapeutics; mobile phone",
abstract="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. ",
issn="1438-8871",
doi="10.2196/13520",
url="http://www.jmir.org/2019/4/e13520/",
url="https://doi.org/10.2196/13520",
url="http://www.ncbi.nlm.nih.gov/pubmed/30982776"
}