Wear-Smile: A Multidisciplinary Telemedicine-Based Smoking Cessation Program Assisted by Wearable Monitoring Devices for Persons Who Smoke—Protocol for a Randomized Controlled Trial

Background: Tobacco smoking remains one of the leading preventable causes of morbidity and mortality worldwide and is associated with cardiovascular, respiratory, oral, and psychological disorders. Although conventional smoking cessation interventions are effective, barriers related to accessibility, adherence, healthcare costs, and continuity of care frequently limit long-term success. Recent advances in technology may offer innovative opportunities to improve multidisciplinary smoking cessation pathways. Methodology: The Wear-Smile project is a non-profit, monocentric, randomized controlled trial registered in the Clinical Trial Protocol Registry and Results System (code No.: NCT07593742), designed to evaluate the effectiveness of a multidisciplinary telemedicine-based smoking cessation program assisted by wearable remote-monitoring devices. Adults who smoke combustible or heated tobacco or electronic nicotine delivery systems will be randomly allocated in a 1:1 ratio to either an experimental group receiving telemedicine-assisted rehabilitation integrated with wearable monitoring devices or a control group receiving standard in-person smoking cessation care. The intervention will include a multidisciplinary behavioral smoking cessation intervention involving cardiology, respiratory, dental, and psychology specialists. Primary outcomes will include Continuous Abstinence Rates and Point Prevalence Abstinence assessed at 6 and 12 months. Secondary outcomes will include cardiopulmonary and oral health parameters, smoking-related variables, health- and oral health-related quality of life (QoL), as well as adherence, usability, acceptability, and satisfaction with the rehabilitation program. Conclusions: The project may provide preliminary evidence regarding the potential feasibility, acceptability, and effectiveness of a multidisciplinary smoking cessation program integrating telemedicine and wearable monitoring technologies in improving abstinence outcomes, patient engagement, continuity of care, and QoL.