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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Alessia Bramanti, Associate Professor
- 電話番号:+393483809181
- メール:abramanti@unisa.it
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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)
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:支持療法
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的: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.
|
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.
|
|
アクティブコンパレータ: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.
|
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.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Continuous Abstinence Rate (CAR) from tobacco and nicotine-containing products
時間枠: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.
|
6 months and 12 months after baseline
|
|
Point Prevalence Abstinence (PPA)
時間枠: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.
|
6 months and 12 months after baseline
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Heart rate
時間枠:Daily monitoring and evaluation at 6 and 12 months
|
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
時間枠:Daily monitoring and evaluation at 6 and 12 months.
|
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
時間枠:Daily monitoring and evaluation at 6 and 12 months.
|
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
時間枠:Daily monitoring and evaluation at 6 and 12 months.
|
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
時間枠:Baseline, 6 months, and 12 months
|
Changes in periodontal probing depth (millimeters, mm), measured during standardized dental examinations.
|
Baseline, 6 months, and 12 months
|
|
Full-mouth bleeding index
時間枠:Baseline, 6 months, and 12 months.
|
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
時間枠:Baseline, 6 months, and 12 months.
|
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
時間枠:Baseline, 6 months, and 12 months
|
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
時間枠:Baseline, 6 months, and 12 months
|
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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Nicotine dependence severity
時間枠:Baseline, 6 months, and 12 months
|
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
時間枠:6 months and 12 months
|
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
時間枠:6 months and 12 months
|
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
時間枠:6 months and 12 months
|
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
|
協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- 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.
便利なリンク
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 4196/2025
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。