Comparing Telemedicine and Face-to-Face Consultation Based on the Standard Smoking Cessation Program for Nicotine Dependence: Protocol for a Randomized Controlled Trial (Preprint)

BACKGROUND Smoking is a major public health concern. In Japan, a 12-week standard smoking cessation support program is available, however, its required face-to-face visits are a key obstacle in completing the program. Telemedicine is a useful way to provide medical treatment at a distance. Although telemedicine for smoking cessation using an internet-based video system has the potential for ensuring better clinical outcomes for patients with nicotine dependence, its efficacy is unclear. OBJECTIVE The aim of this study is to determine the efficacy and feasibility of a smoking cessation support program using an internet-based video system compared with a face-to-face program among patients with nicotine dependence. METHODS This study will be a randomized, controlled, open-label, multicenter trial. Participants randomized to the intervention arm will undergo an internet-based smoking cessation program, whereas control participants will undergo a standard face-to-face program. We will use the CureApp Smoking Cessation (CASC) for both arms, which consists of the CASC smartphone app for patients and a Web-based patient information management system for clinicians with a mobile carbon monoxide checking device. The primary endpoint will be the continuous abstinence rate (CAR) from weeks 9 to 12. Secondary endpoints will be: (1) the smoking cessation success rate at 4, 8, 12, and 24 weeks; (2) CAR from weeks 9 to 24; (3) changes in scores on the mood and physical symptoms scale and 12-Item French Version Of The Tobacco Craving Questionnaire; (4) Kano Test for Social Nicotine Dependence scores at 8, 12, and 24 weeks; (5) time to first lapse after the first visit; (6) nicotine dependence and cognition scale scores at 12 and 24 weeks; (7) usage rate of the CASC; (8) qualitative questionnaire about the usability and acceptability of telemedicine; and (9) presence of product problems or adverse events. RESULTS We will recruit 114 participants who are nicotine-dependent but otherwise healthy adults from March to July 2018 and follow up with them until January 2019 (24 weeks). We expect all study results to be available by the end of March 2019. CONCLUSIONS This will be the first randomized controlled trial to evaluate the efficacy and feasibility of an internet-based (telemedicine) smoking cessation support program relative to a face-to-face program among patients with nicotine dependence. We expect that the efficacy of the telemedicine smoking cessation support program will not be clinically worse than the face-to-face program. If this trial demonstrates that telemedicine does not have clinically worse efficacy and feasibility than a conventional face-to-face program, physicians can begin to offer a more flexible smoking cessation program to patients who may otherwise give up on trying such programs. CLINICALTRIAL University Hospital Medical Information Network Clinical Trials Registry: UMIN000031620; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035975 INTERNATIONAL REGISTERED REPOR DERR1-10.2196/12701