Tobacco smoking remains one of the leading preventable causes of disease, disability, and premature death worldwide. According to the World Health Organization, tobacco use is responsible for more than eight million deaths each year globally, including deaths caused by direct smoking and exposure to secondhand smoke. Smoking is a major risk factor for a wide range of chronic diseases, including cardiovascular diseases, chronic respiratory diseases, several types of cancer, and numerous oral health conditions. In addition to systemic effects, tobacco use is strongly associated with oral potentially malignant disorders and oral squamous cell carcinoma, representing a significant burden for public health systems.
Despite the well-documented health risks, smoking cessation remains difficult for many individuals due to the addictive properties of nicotine and the complex behavioral and psychological components associated with tobacco dependence. Multimodal smoking cessation programs that combine behavioral counseling, psychological support, and continuous monitoring have been shown to increase the likelihood of successful cessation. However, access to these programs may be limited by logistical barriers, including geographic distance, time constraints, and limited availability of specialized services.
In recent years, telemedicine and digital health technologies have emerged as promising tools to support healthcare delivery and improve access to treatment programs. Telemedicine platforms allow remote interaction between patients and healthcare professionals, facilitating communication, follow-up, and monitoring of patients over time. Additionally, wearable devices and remote monitoring systems enable the collection of physiological and behavioral data outside traditional clinical settings, providing clinicians with valuable information to support personalized interventions.
The aim of this study is to evaluate the effectiveness and feasibility of a smoking cessation program delivered through a telerehabilitation model supported by an integrated telemedicine platform and wearable remote monitoring devices. The program is designed to support individuals who smoke tobacco products, including both combustible tobacco and alternative nicotine-containing products, by providing behavioral and psychological interventions combined with continuous remote monitoring.
Participants enrolled in the study will be assigned to one of two groups. The intervention group will participate in a telerehabilitation program delivered through a dedicated telemedicine platform. This program will include structured behavioral and psychological treatment sessions aimed at supporting smoking cessation, along with remote monitoring through non-invasive wearable devices that allow healthcare professionals to track selected physiological parameters and patient engagement during the treatment process.
The control group will receive the same multimodal behavioral and psychological treatment program but delivered through conventional rehabilitation methods without the use of telemedicine technologies or wearable monitoring devices.
By comparing these two approaches, the study aims to explore whether the integration of telemedicine and wearable technologies into smoking cessation programs may improve patient engagement, facilitate monitoring, and potentially enhance the effectiveness of behavioral interventions aimed at reducing tobacco use. The findings of this study may contribute to the development of innovative digital health strategies for smoking cessation and provide evidence to support the integration of telemedicine into addiction treatment and preventive healthcare programs.
Subjects who smoke ≥ 5 cigarettes per day (traditional or equivalent in nicotine content in non-combustible tobacco or liquid/vape), regardless of the severity of nicotine dependence
Subjects ≥ 18 years of age
Ability and willingness to provide informed consent or presence of a legal representative who consents
Subjects in possession of home medical devices for measuring cardiopulmonary parameters (sphygmomanometer and pulse oximeter) (requirement applicable to participants assigned to the control group)
Age < 18
Pregnant or breastfeeding women
Subjects with a remote or current history of using smoking cessation methods
Subjects with acute dependence on alcohol or other substances of abuse other than nicotine
Parallel
Telemedicine-Based Smoking Cessation Program
BehavioralParticipants receive a personalized multimodal behavioral and psychological smoking cessation intervention delivered through a telemedicine platform. The intervention includes individual counseling, cognitive behavioral therapy, and motivational support provided remotely. The telemedicine system is web-based and accessible from computers or mobile devices (Android or iOS). Participants may also use non-invasive wearable devices integrated with the telemedicine platform to remotely monitor vital parameters, including heart rate, blood pressure, respiratory rate, and oxygen saturation, measured twice daily for up to 12 months. Smoking behavior is recorded using a standardized smoking diary. The telemedicine platform allows clinicians to monitor participants' progress and conduct teleconsultations when needed.
Conventional Smoking Cessation Behavioral Program
BehavioralParticipants receive a personalized multimodal behavioral and psychological smoking cessation intervention delivered through conventional in-person clinical care according to national clinical guidelines. The intervention includes individual counseling, cognitive behavioral therapy, and motivational support provided during face-to-face visits. Follow-up sessions are scheduled two weeks after the initial consultation and then monthly for up to 12 months to support smoking cessation and prevent relapse. Participants record smoking behavior using a standardized smoking diary and monitor cardiopulmonary parameters at home using portable medical devices.
Continuous Abstinence Rate (CAR) from tobacco and nicotine-containing products
Continuous abstinence rate (CAR) defined as the proportion (%) of participants who remain completely abstinent from combustible and non-combustible tobacco and nicotine-containing products from the start of the cessation program to the follow-up assessment at 6 and 12 months. Abstinence will be assessed through participant self-report using a standardized smoking diary.
Point Prevalence Abstinence (PPA)
Point prevalence abstinence (PPA) defined as the proportion (%) of participants reporting no use of combustible or non-combustible tobacco products at the time of follow-up assessment.
Heart rate
Changes in heart rate (beats per minute, bpm) measured through wearable monitoring devices (telerehabilitation group) or home medical devices (control group).
Blood pressure
Changes in blood pressure (millimeters of mercury, mmHg) measured through wearable monitoring devices (telerehabilitation group) or home medical devices (control group).
Respiratory rate
Changes in respiratory rate (breaths/minute) measured through wearable monitoring devices (telerehabilitation group) or home medical devices (control group).
Oxygen Saturation
Changes in oxygen saturation (SpO₂, %), measured through wearable monitoring devices (telerehabilitation group) or home medical devices (control group).
Nicotine dependence severity
Nicotine dependence measured using the Fagerström Test for Nicotine Dependence (FTND). FTND scores range from 0 to 10, with higher scores indicating greater nicotine dependence.
Usability
Usability with the smoking cessation program will be assessed using the System Usability Scale (SUS). SUS scores range from 0 to 100, with higher scores indicating better usability.
Acceptability
Acceptability with the smoking cessation program will be assessed using the Treatment Acceptability/Adherence Scale (TAAS). TAAS scores range from 10 to 70, with higher scores indicating better acceptability.
Patient and Doctor Satisfaction
Satisfaction with the smoking cessation program will be assessed using the Client Satisfaction Questionnaire (CSQ-8). CSQ-8 scores range from 8 to 32, with higher scores indicating greater satisfaction.
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