Smoking ( Cigarette)Wear-SmileNCT07593742
Smoking Cessation With Wearables to Improve General, Oral Health and Quality of Life
A study testing Telemedicine-Based Smoking Cessation Program and Conventional Smoking Cessation Behavioral Program in people with Smoking ( Cigarette) and Smoking (Tobacco) Addiction, run by University of Salerno.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking ( Cigarette), Smoking (Tobacco) Addiction, Smoking Behaviors
- What is being tested?
- Telemedicine-Based Smoking Cessation Program and Conventional Smoking Cessation Behavioral Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Smoking ( Cigarette), Smoking (Tobacco) Addiction, Smoking Behaviors, Smoking Cessation, Smoking Dependence, Smoking Addiction
- Being tested
- Telemedicine-Based Smoking Cessation Program, Conventional Smoking Cessation Behavioral Program
- Keywords
- Smoking, Smoking cessation, Smoking addiction, Tobacco, Wearable device, Telerehabilitation, Oral Health, Periodontal Health, General Health, Quality of life, Periodontal disease, E-cigarette, Heat not burn tobacco, Smoking abstinence
- Medical subject headings
- Cigarette Smoking, Smoking, Behavior, Addictive, Smoking Cessation, Periodontal Diseases, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine-Based Smoking Cessation ProgramBehavioural
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.
Conventional Smoking Cessation Behavioral ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation Smoking Cessation Program | Experimental | 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. Receives: Behavioral: Telemedicine-Based Smoking Cessation Program |
| Conventional Rehabilitation Smoking Cessation Program | Active comparator | 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. Receives: Behavioral: Conventional Smoking Cessation Behavioral Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months and 12 months after baseline
Secondary outcomes (9)
Heart rate
Changes in heart rate (beats per minute, bpm) measured through wearable monitoring devices (telerehabilitation group) or home medical devices (control group).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Daily monitoring and evaluation at 6 and 12 months.
Probing depth
Changes in periodontal probing depth (millimeters, mm), measured during standardized dental examinations.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Smoking ( Cigarette)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salerno
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessia Bramanti, University of Salerno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593742
- Sponsor's protocol ID
- 4196/2025
- Acronym
- Wear-Smile
- Status last verified
- Jan 2026
- First submitted
- 9 Mar 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 32383274Jimenez-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.
PubMed 25882805Visseren 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.
PubMed 34458905Hajesmaeel-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.
PubMed 35081953Di 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.
PubMed 38541672Franchignoni 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.
PubMed 21302527Apolone 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.
PubMed 9817120Fagerstrom 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.
PubMed 8795860West 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.
PubMed 17362283Mersha 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.
PubMed 39134180Guo 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.
PubMed 37079352Hoogendijk 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.
PubMed 31609228Taylor 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.
PubMed 33687070Ford PJ, Rich AM. Tobacco Use and Oral Health. Addiction. 2021 Dec;116(12):3531-3540. doi: 10.1111/add.15513. Epub 2021 Apr 25.
PubMed 33822437
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07593742
- Acronym / sponsor ID
- Wear-Smile / 4196/2025
- Conditions
- Smoking ( Cigarette), Smoking (Tobacco) Addiction, Smoking Behaviors, Smoking Cessation, Smoking Dependence, Smoking Addiction
- Keywords
- Smoking, Smoking cessation, Smoking addiction, Tobacco, Wearable device, Telerehabilitation, Oral Health, Periodontal Health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- University of SalernoUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation Smoking Cessation Program | Experimental | Behavioral: Telemedicine-Based Smoking Cessation ProgramSubjects 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. |
| Conventional Rehabilitation Smoking Cessation Program | Active comparator | Behavioral: Conventional Smoking Cessation Behavioral ProgramSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemedicine-Based Smoking Cessation ProgramParticipants 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. | Behavioural | Telerehabilitation Smoking Cessation Program |
| Conventional Smoking Cessation Behavioral ProgramParticipants 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. | Behavioural | Conventional Rehabilitation Smoking Cessation Program |
Primary outcome
Continuous Abstinence Rate (CAR) from tobacco and nicotine-containing products
Time frame: 6 months and 12 months after baseline
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)
Time frame: 6 months and 12 months after baseline
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.
9 secondary outcomes
Heart rate
Time frame: Daily monitoring and evaluation at 6 and 12 months
Blood pressure
Time frame: Daily monitoring and evaluation at 6 and 12 months.
Respiratory rate
Time frame: Daily monitoring and evaluation at 6 and 12 months.
Oxygen Saturation
Time frame: Daily monitoring and evaluation at 6 and 12 months.
Probing depth
Time frame: Baseline, 6 months, and 12 months
Full-mouth bleeding index
Time frame: Baseline, 6 months, and 12 months.
Full-mouth plaque index
Time frame: Baseline, 6 months, and 12 months.
Oral health related quality of life
Time frame: Baseline, 6 months, and 12 months
Health-related quality of life
Time frame: Baseline, 6 months, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Background: PubMed 32383274Sanz 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.
- Background: PubMed 25882805Jimenez-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.
- Background: PubMed 34458905Visseren 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.
- Background: PubMed 35081953Hajesmaeel-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.
- Background: PubMed 38541672Di 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.
- Background: PubMed 21302527Franchignoni 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.
- Background: PubMed 9817120Apolone 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.
- Background: PubMed 8795860Fagerstrom 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.
- Background: PubMed 17362283West 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.
- Background: PubMed 39134180Mersha 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.
- Background: PubMed 37079352Guo 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.
- Background: PubMed 31609228Hoogendijk 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.
- World Health Organization (WHO). Tobacco. 2023.Link provided by the sponsor.
- Ministero della Salute \& Istituto Superiore di Sanità. Linee guida cliniche per promuovere la cessazione dell'abitudine al fumo. 2008.Link provided by the sponsor.
- Società Italiana di Parodontologia e Implantologia (SIdP) \& European Federation of Periodontology (EFP). Test di autovalutazione delle gengive.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine-Based Smoking Cessation Program and Conventional Smoking Cessation Behavioral Program in people with Smoking ( Cigarette) and Smoking (Tobacco) Addiction, run by University of Salerno.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessia Bramanti, Associate Professor (+393483809181, abramanti@unisa.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous Abstinence Rate (CAR) from tobacco and nicotine-containing products (time frame: 6 months and 12 months after baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07593742, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.