Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Jan 28, 2019
Open Peer Review Period: Jan 29, 2019 - Feb 5, 2019
Date Accepted: Apr 11, 2019
Date Submitted to PubMed: Apr 15, 2019
(closed for review but you can still tweet)
Clinical Efficacy of Telemedicine Compared with Face-to-face Clinic Visit on Smoking Cessation: A Multi-center, Open-label, Randomized Controlled, Non-inferiority Trial
ABSTRACT
Background:
Tobacco is a major public health concern. A 12-week standard smoking cessation program is available in Japan; however, its required face-to-face clinic visits has been one of the key obstacles to completing the program, leading to a low smoking cessation success rate. Telemedicine using an internet-based video counseling instead of regular clinic visits could address the obstacles.
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, multi-center, non-inferiority trial. We recruited nicotine-dependent adults from March to June 2018. Participants randomized to the telemedicine arm underwent an internet-based video counseling, whereas control participants underwent standard face-to-face clinical visits at each time point on the smoking cessation program. Both arms received a CureApp Smoking Cessation smartphone application with a mobile exhaled carbon monoxide checker. The primary outcome was a continuous abstinence rate (CAR) at weeks 9–12. We conducted all analyses by full analysis set.
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 at weeks 9–12 (telemedicine vs. control, 81.0% vs. 78.9%; absolute difference, 2.1%; 95% confidence interval, -12.8 to 17.0); the lower limit of the difference between groups (-12.8%) was greater than a pre-specified limit (-15%).
Conclusions:
The application of telemedicine using internet-based video counseling as a smoking cessation program had a similar CAR at weeks 9–12 as the standard face-to-face clinical visit program. The efficacy of the telemedicine-based smoking cessation program was non-inferior to that of the standard visit-based smoking cessation program. Clinical Trial: This trial was registered at the University Hospital Medical Information Network (UMIN) Clinical Trials Registry (UMIN ID: UMIN000031620).
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