JMIR Publications

ABSTRACT

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 to complete the program. Telemedicine is a useful mean of providing medical treatment in distance. While 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:

We aim to determine the efficacy and safety 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, multi-center trial. Participants randomized to the intervention arm will undergo an internet-based smoking cessation program while control participants will undergo a standard face-to-face program. We will use the ‘CureApp Smoking Cessation (CASC)’ for both arms, which consists of a CureApp smoking cessation smartphone application for patients and a web-based patient information management system for clinicians with a mobile carbon monoxide (CO) checking device. The primary endpoint will be the continuous abstinence rate (CAR) at 9–12 weeks. Secondary endpoints will be the smoking cessation success rate at 4, 8, 12, and 24 weeks; CAR at 9–24 weeks; changes in scores on the Mood and Physical Symptoms Scale and 12-item French version of the Tobacco Craving Questionnaire; Kano Test for Social Nicotine Dependence scores at 8, 12, and 24 weeks; time to first lapse after first visit; Nicotine Dependence Cognition Scale scores at 12 and 24 weeks; usage rate of the CASC; and presence of product problems or adverse events.

Results:

We will recruit 114 participants who are nicotine-dependent, otherwise healthy adults from March to July 2018, and follow them up 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 safety 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 safety 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 trying such programs. Clinical Trial: This study is registered at the University Hospital Medical Information Network (UMIN) Clinical Trials Registry (UMIN ID: UMIN000031620).