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Randomized Controlled Trial
. 2019 Apr 26;21(4):e13520.
doi: 10.2196/13520.

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

Akihiro Nomura  1   2   3 , Tomoyuki Tanigawa  1   4 , Tomoyasu Muto  5 , Takafumi Oga  6 , Yasushi Fukushima  7 , Arihiro Kiyosue  8 , Masaki Miyazaki  9 , Eisuke Hida  10 , Kohta Satake  1   5
Affiliations
Randomized Controlled Trial

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

Akihiro Nomura et al. J Med Internet Res. .

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.

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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.

Figures

Figure 1
Figure 1
Trial flowchart. CASC: CureApp Smoking Cessation; SC: smoking cessation.
See this image and copyright information in PMC

References

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