Clinical Efficacy of Telemedicine Compared to Face-to-Face Clinic Visits for Smoking Cessation: Multicenter Open-Label Randomized Controlled Noninferiority Trial

Akihiro Nomura, Tomoyuki Tanigawa, Tomoyasu Muto, Takafumi Oga, Yasushi Fukushima, Arihiro Kiyosue, Masaki Miyazaki, Eisuke Hida, Kohta Satake, Akihiro Nomura, Tomoyuki Tanigawa, Tomoyasu Muto, Takafumi Oga, Yasushi Fukushima, Arihiro Kiyosue, Masaki Miyazaki, Eisuke Hida, Kohta Satake

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.

Keywords: digital therapeutics; mHealth; mobile phone; nicotine dependence; smoking cessation; telecare; telemedicine.

Conflict of interest statement

Conflicts of Interest: This trial was supported by CureApp, Inc. AN received consulting fees from CureApp, Inc. TT and TM are employees of CureApp, Inc. KS is the founder and a shareholder of CureApp, Inc, and patent holder of the CASC system. EH has a consultation contract as a biostatistician with CureApp, Inc. TO, YF, AK and MM received research support fees from CureApp, Inc.

©Akihiro Nomura, Tomoyuki Tanigawa, Tomoyasu Muto, Takafumi Oga, Yasushi Fukushima, Arihiro Kiyosue, Masaki Miyazaki, Eisuke Hida, Kohta Satake. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 26.04.2019.

Figures

Figure 1
Figure 1
Trial flowchart. CASC: CureApp Smoking Cessation; SC: smoking cessation.

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