Smoking Cessation With Wearables to Improve General, Oral Health and Quality of Life

NCT07593742 | Not Yet Recruiting

• 1 other identifier: 4196/2025
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Smoking (Tobacco) Addiction; Smoking Behaviors; Smoking Dependence; Smoking Addiction; Smoking Cessation Intervention; Smoking E-cigarette; Smoking Abstinence; Smoking ( Cigarette); Smoking Cessation

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Heart rate

  Daily monitoring and evaluation at 6 and 12 months

• Blood pressure

  Daily monitoring and evaluation at 6 and 12 months.

• Respiratory rate

  Daily monitoring and evaluation at 6 and 12 months.

• Oxygen Saturation

  Daily monitoring and evaluation at 6 and 12 months.

• Probing depth

  Baseline, 6 months, and 12 months

Other Outcomes (4)

• Nicotine dependence severity

  Baseline, 6 months, and 12 months

• Usability

  6 months and 12 months

• Acceptability

  6 months and 12 months

Study Arms (2)

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.

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.

Behavioral: Conventional Smoking Cessation Behavioral Program

Interventions

Telemedicine-Based Smoking Cessation Program BEHAVIORAL

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.

Telerehabilitation Smoking Cessation Program

Conventional Smoking Cessation Behavioral Program BEHAVIORAL

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.

Conventional Rehabilitation Smoking Cessation Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Salerno: lead

Related Publications (14)

• 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.

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• 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.

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• 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.

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• 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.

  PMID: 38541672 BACKGROUND

• 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.

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• 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.

  PMID: 8795860 BACKGROUND

• 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.

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• 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.

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• 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.

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• 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.

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• 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.

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Related 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.

MeSH Terms

Conditions

Cigarette Smoking; Smoking; Behavior, Addictive; Smoking Cessation; Periodontal Diseases; Vaping

Condition Hierarchy (Ancestors)

Tobacco Smoking; Behavior; Tobacco Use; Compulsive Behavior; Impulsive Behavior; Health Behavior; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Alessia Bramanti, Associate Professor

CONTACT

+393483809181; abramanti@unisa.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: May 18, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: May 18, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share