Smoking Cessation With Wearables to Improve General, Oral Health and Quality of Life (Wear-Smile)

Smoking Cessation Programme in Telerehabilitation Assisted by Telemonitoring With Non-Invasive Wearable Devices for the Improvement of Oral Health, General Health and Quality of Life

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Smoking Cessation; Smoking Behaviors; Smoking Dependence; Smoking Abstinence; Smoking Cessation Intervention; Smoking (Tobacco) Addiction; Smoking E-cigarette; Smoking Addiction; Smoking ( Cigarette)
• Intervention / Treatment: Behavioral: Telemedicine-Based Smoking Cessation Program; Behavioral: Conventional Smoking Cessation Behavioral Program

Detailed Description

Tobacco smoking continues to represent one of the most significant and preventable causes of morbidity and mortality worldwide. According to the World Health Organization, tobacco use is responsible for more than eight million deaths every year globally, including deaths caused by direct smoking and those attributable to exposure to secondhand smoke. Tobacco consumption is associated with a wide range of chronic diseases that affect multiple organ systems, including cardiovascular diseases, respiratory disorders, metabolic conditions, and numerous forms of cancer. As a result, smoking represents a major public health concern and a substantial burden for healthcare systems worldwide.

The negative health effects of tobacco use extend beyond systemic diseases and include important implications for oral health. Smoking is strongly associated with oral inflammatory diseases, periodontal disease, delayed wound healing, and a significantly increased risk of oral potentially malignant disorders and oral squamous cell carcinoma. For these reasons, smoking cessation plays a critical role in both preventive medicine and oral healthcare. Promoting effective strategies to support smoking cessation is therefore a priority for public health initiatives and clinical practice.

Despite the well-documented health risks associated with tobacco use, many individuals continue to smoke due to the addictive properties of nicotine and the complex psychological, behavioral, and social factors involved in tobacco dependence. Nicotine addiction is characterized by both physiological dependence and behavioral reinforcement mechanisms that make quitting smoking particularly challenging. Many smokers attempt to quit multiple times before achieving long-term abstinence, and relapse rates remain high without structured support.

Evidence suggests that smoking cessation interventions are more effective when they combine multiple treatment components. Multimodal approaches that include behavioral counseling, psychological support, motivational strategies, and continuous monitoring have been shown to increase the probability of successful smoking cessation compared with minimal interventions or self-directed attempts to quit. However, access to structured smoking cessation programs remains limited in many contexts due to barriers such as geographic distance, time constraints, lack of specialized services, and difficulties maintaining long-term follow-up.

In recent years, telemedicine and digital health technologies have emerged as promising tools to improve the accessibility, continuity, and effectiveness of healthcare interventions. Telemedicine refers to the delivery of healthcare services through digital communication technologies that allow remote interaction between patients and healthcare professionals. Telemedicine platforms can facilitate clinical consultations, follow-up visits, behavioral counseling, and patient monitoring without requiring in-person attendance at healthcare facilities.

The use of telemedicine in behavioral health interventions has expanded significantly in recent years, particularly following the global COVID-19 pandemic, which accelerated the adoption of remote healthcare services. Telehealth approaches have demonstrated potential benefits in terms of improving access to care, reducing logistical barriers, and maintaining continuity of treatment for patients who may otherwise face difficulties attending traditional clinical appointments.

In addition to telecommunication technologies, wearable monitoring devices have become increasingly important tools in digital health. Wearable devices are capable of collecting physiological and behavioral data in real time, allowing healthcare professionals to remotely monitor various parameters such as physical activity, heart rate, sleep patterns, and other health indicators. The integration of wearable monitoring systems into telemedicine platforms may further enhance the capacity to provide personalized and continuous care.

Within the context of smoking cessation programs, remote monitoring technologies may support clinicians in evaluating patient engagement, monitoring behavioral changes, and identifying potential challenges during the cessation process. Continuous monitoring and regular communication between patients and healthcare professionals may help improve adherence to treatment protocols and provide timely support when needed.

The present study aims to investigate the feasibility and effectiveness of a smoking cessation program delivered through a telerehabilitation model supported by an integrated telemedicine platform and wearable remote monitoring devices. Telerehabilitation refers to the remote delivery of rehabilitation services using digital communication technologies and remote monitoring systems. This approach allows healthcare professionals to provide structured treatment programs while maintaining continuous contact with patients in their everyday environments.

Participants eligible for the study will include adult individuals who smoke tobacco products, including both combustible tobacco and alternative nicotine-containing products. Eligible participants will be recruited and assigned to one of two study groups.

Participants in the intervention group will take part in a telerehabilitation-based smoking cessation program delivered through an integrated telemedicine platform. The intervention will include multimodal behavioral and psychological treatment designed to support smoking cessation through structured counseling sessions, motivational strategies, and continuous monitoring. Participants in this group will also use non-invasive wearable monitoring devices that enable healthcare professionals to remotely collect selected physiological and behavioral data during the treatment process. These devices will allow clinicians to monitor patient engagement and support individualized follow-up throughout the program.

Participants assigned to the control group will receive the same multimodal behavioral and psychological smoking cessation program delivered through conventional rehabilitation methods. In this case, treatment will be provided without the support of telemedicine platforms or wearable monitoring technologies. The control group therefore represents the standard rehabilitation approach typically used in clinical practice.

By comparing these two groups, the study aims to evaluate whether the integration of telemedicine technologies and wearable monitoring devices into smoking cessation programs may improve treatment delivery, enhance patient engagement, and support better monitoring during the rehabilitation process. The study will also explore the feasibility of implementing telerehabilitation approaches in the context of smoking cessation and behavioral health interventions.

The results of this study may contribute to the growing body of evidence supporting the use of digital health technologies in addiction treatment and preventive healthcare. Furthermore, the findings may provide valuable insights for the development of scalable and accessible smoking cessation programs that can be implemented in different healthcare settings, helping to expand access to effective interventions for individuals seeking to quit tobacco use.

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alessia Bramanti, Associate Professor; Phone Number: +393483809181; Email: abramanti@unisa.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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
• Pathologies with advanced neurocognitive degeneration
• Unstable psychiatric conditions (subjects with active suicidal ideation, hospitalization for psychiatric reasons and/or changes in psychiatric medication for less than 3 months)
• Inability or refusal to sign informed consent
• Inability to access the integrated telemedicine platform and/or wearable remote monitoring devices (requirement applicable to participants assigned to the experimental group)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telerehabilitation Smoking Cessation Program; Subjects who smoke tobacco with and without combustion and products containing nicotine in telerehabilitation. Assisted, monitored and undergoing multimodal treatment (behavioural-psychological treatment) with the aid of an integrated telemedicine platform and wearable remote monitoring devices.	Behavioral: Telemedicine-Based Smoking Cessation Program; Participants 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.
Active Comparator: Conventional Rehabilitation Smoking Cessation Program; Subjects who smoke combustible and non-combustible tobacco and nicotine-containing products in conventional rehabilitation. Assisted, monitored and undergoing multimodal behavioural-psychological treatment (similar to the study group) without the aid of an integrated telemedicine platform and wearable remote monitoring devices.	Behavioral: Conventional Smoking Cessation Behavioral Program; Participants 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months and 12 months after baseline
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.	6 months and 12 months after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate	Changes in heart rate (beats per minute, bpm) measured through wearable monitoring devices (telerehabilitation group) or home medical devices (control group).	Daily monitoring and evaluation at 6 and 12 months
Blood pressure	Changes in blood pressure (millimeters of mercury, mmHg) measured through wearable monitoring devices (telerehabilitation group) or home medical devices (control group).	Daily monitoring and evaluation at 6 and 12 months.
Respiratory rate	Changes in respiratory rate (breaths/minute) measured through wearable monitoring devices (telerehabilitation group) or home medical devices (control group).	Daily monitoring and evaluation at 6 and 12 months.
Oxygen Saturation	Changes in oxygen saturation (SpO₂, %), measured through wearable monitoring devices (telerehabilitation group) or home medical devices (control group).	Daily monitoring and evaluation at 6 and 12 months.
Probing depth	Changes in periodontal probing depth (millimeters, mm), measured during standardized dental examinations.	Baseline, 6 months, and 12 months
Full-mouth bleeding index	Changes in full-mouth bleeding index, expressed as the percentage (%) of bleeding sites, measured during standardized dental examinations. Higher percentages indicate worse periodontal status.	Baseline, 6 months, and 12 months.
Full-mouth plaque index	Changes in full-mouth plaque index (%) of plaque-positive sites, measured during standardized dental examinations. Higher percentages indicate worse oral hygiene status.	Baseline, 6 months, and 12 months.
Oral health related quality of life	Oral health-related quality of life measured using the Oral Health Impact Profile (OHIP-14). Scores range from 0 to 56, with higher scores indicating worse oral health-related quality of life.	Baseline, 6 months, and 12 months
Health-related quality of life	Health-related quality of life measured using the Short Form Health Survey (SF-36). Scores range from 0 to 100, with higher scores indicating better health-related quality of life.	Baseline, 6 months, and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 6 months, and 12 months
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.	6 months and 12 months
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.	6 months and 12 months
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.	6 months and 12 months

Collaborators and Investigators

• Sponsor: University of Salerno

Publications and helpful links

General Publications

• Apolone G, Mosconi P. The Italian SF-36 Health Survey: translation, validation and norming. J Clin Epidemiol. 1998 Nov;51(11):1025-36. doi: 10.1016/s0895-4356(98)00094-8.
• West R. The clinical significance of "small" effects of smoking cessation treatments. Addiction. 2007 Apr;102(4):506-9. doi: 10.1111/j.1360-0443.2007.01750.x. No abstract available.
• Hoogendijk EO, Afilalo J, Ensrud KE, Kowal P, Onder G, Fried LP. Frailty: implications for clinical practice and public health. Lancet. 2019 Oct 12;394(10206):1365-1375. doi: 10.1016/S0140-6736(19)31786-6.
• Franchignoni M, Giordano A, Brigatti E, Migliario M, Levrini L, Ferriero G. [Psychometric properties of the Italian version of the reduced form of the Oral Health Impact Profile (OHIP-14)]. G Ital Med Lav Ergon. 2010 Jul-Sep;32(3 Suppl B):B71-8. Italian.
• Guo YQ, Chen Y, Dabbs AD, Wu Y. The Effectiveness of Smartphone App-Based Interventions for Assisting Smoking Cessation: Systematic Review and Meta-analysis. J Med Internet Res. 2023 Apr 20;25:e43242. doi: 10.2196/43242.
• Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Back M, Benetos A, Biffi A, Boavida JM, Capodanno D, Cosyns B, Crawford C, Davos CH, Desormais I, Di Angelantonio E, Franco OH, Halvorsen S, Hobbs FDR, Hollander M, Jankowska EA, Michal M, Sacco S, Sattar N, Tokgozoglu L, Tonstad S, Tsioufis KP, van Dis I, van Gelder IC, Wanner C, Williams B; ESC National Cardiac Societies; ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J. 2021 Sep 7;42(34):3227-3337. doi: 10.1093/eurheartj/ehab484. No abstract available.
• Hajesmaeel-Gohari S, Khordastan F, Fatehi F, Samzadeh H, Bahaadinbeigy K. The most used questionnaires for evaluating satisfaction, usability, acceptance, and quality outcomes of mobile health. BMC Med Inform Decis Mak. 2022 Jan 27;22(1):22. doi: 10.1186/s12911-022-01764-2.
• Sanz M, Herrera D, Kebschull M, Chapple I, Jepsen S, Beglundh T, Sculean A, Tonetti MS; EFP Workshop Participants and Methodological Consultants. Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline. J Clin Periodontol. 2020 Jul;47 Suppl 22(Suppl 22):4-60. doi: 10.1111/jcpe.13290.
• Jimenez-Ruiz CA, Andreas S, Lewis KE, Tonnesen P, van Schayck CP, Hajek P, Tonstad S, Dautzenberg B, Fletcher M, Masefield S, Powell P, Hering T, Nardini S, Tonia T, Gratziou C. Statement on smoking cessation in COPD and other pulmonary diseases and in smokers with comorbidities who find it difficult to quit. Eur Respir J. 2015 Jul;46(1):61-79. doi: 10.1183/09031936.00092614. Epub 2015 Apr 16.
• Di Spirito F, Raimondo A, Di Palo MP, Martina S, Fordellone M, Rosa D, Amato M, Lembo S. Oral Lesions and Oral Health-Related Quality of Life in Adult Patients with Psoriasis: A Retrospective Chart Review. Life (Basel). 2024 Mar 7;14(3):347. doi: 10.3390/life14030347.
• Fagerstrom KO, Kunze M, Schoberberger R, Breslau N, Hughes JR, Hurt RD, Puska P, Ramstrom L, Zatonski W. Nicotine dependence versus smoking prevalence: comparisons among countries and categories of smokers. Tob Control. 1996 Spring;5(1):52-6. doi: 10.1136/tc.5.1.52.
• Mersha AG, Bryant J, Booth K, Watson L, Kennedy M. The effectiveness of internet-based group behavioural interventions on lifestyle modifications: A systematic review. Prev Med. 2024 Sep;186:108099. doi: 10.1016/j.ypmed.2024.108099. Epub 2024 Aug 10.
• Taylor GM, Lindson N, Farley A, Leinberger-Jabari A, Sawyer K, Te Water Naude R, Theodoulou A, King N, Burke C, Aveyard P. Smoking cessation for improving mental health. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD013522. doi: 10.1002/14651858.CD013522.pub2.
• Ford PJ, Rich AM. Tobacco Use and Oral Health. Addiction. 2021 Dec;116(12):3531-3540. doi: 10.1111/add.15513. Epub 2021 Apr 25.

Helpful Links

• World Health Organization (WHO). Tobacco. 2023.
• Ministero della Salute & Istituto Superiore di Sanità. Diario del fumatore.
• Ministero della Salute & Istituto Superiore di Sanità. Linee guida cliniche per promuovere la cessazione dell'abitudine al fumo. 2008.
• Società Italiana di Parodontologia e Implantologia (SIdP) & European Federation of Periodontology (EFP). Test di autovalutazione delle gengive.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: March 9, 2026
• First Submitted That Met QC Criteria: May 11, 2026
• First Posted (Actual): May 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Quality of life; Smoking; Telerehabilitation; Smoking cessation; Tobacco; Oral Health; Periodontal disease; E-cigarette; Smoking abstinence; Wearable device; General Health; Periodontal Health; Smoking addiction; Heat not burn tobacco
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Compulsive Behavior; Impulsive Behavior; Behavior; Health Behavior; Tobacco Smoking; Tobacco Use; Behavior, Addictive; Periodontal Diseases; Smoking; Vaping; Smoking Cessation; Cigarette Smoking
• Other Study ID Numbers: 4196/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared. Due to privacy and data protection considerations, the dataset contains sensitive health information that cannot be sufficiently de-identified without compromising participant confidentiality. Aggregate results will be reported in publications and presentations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No