Abstract
BackgroundSmoking is considered the main cause of preventable illness and early deaths worldwide. The treatment usually prescribed to people who wish to quit smoking is a multidisciplinary intervention, combining both psychological advice and pharmacological therapy, since the application of both strategies significantly increases the chance of success in a quit attempt.ObjectiveWe present a study protocol of a 12-month randomized open-label parallel-group trial whose primary objective is to analyze the efficacy and efficiency of usual psychopharmacological therapy plus the Social-Local-Mobile app (intervention group) applied to the smoking cessation process compared with usual psychopharmacological therapy alone (control group).MethodsThe target population consists of adult smokers (both male and female) attending the Smoking Cessation Unit at Virgen del Rocío University Hospital, Seville, Spain. Social-Local-Mobile is an innovative intervention based on mobile technologies and their capacity to trigger behavioral changes. The app is a complement to pharmacological therapies to quit smoking by providing personalized motivational messages, physical activity monitoring, lifestyle advice, and distractions (minigames) to help overcome cravings. Usual pharmacological therapy consists of bupropion (Zyntabac 150 mg) or varenicline (Champix 0.5 mg or 1 mg). The main outcomes will be (1) the smoking abstinence rate at 1 year measured by means of exhaled carbon monoxide and urinary cotinine tests, and (2) the result of the cost-effectiveness analysis, which will be expressed in terms of an incremental cost-effectiveness ratio. Secondary outcome measures will be (1) analysis of the safety of pharmacological therapy, (2) analysis of the health-related quality of life of patients, and (3) monitoring of healthy lifestyle and physical exercise habits.ResultsOf 548 patients identified using the hospital’s electronic records system, we excluded 308 patients: 188 declined to participate and 120 did not meet the inclusion criteria. A total of 240 patients were enrolled: the control group (n=120) will receive usual psychopharmacological therapy, while the intervention group (n=120) will receive usual psychopharmacological therapy plus the So-Lo-Mo app. The project was approved for funding in June 2015. Enrollment started in October 2016 and was completed in October 2017. Data gathering was completed in November 2018, and data analysis is under way. The first results are expected to be submitted for publication in early 2019.ConclusionsSocial networks and mobile technologies influence our daily lives and, therefore, may influence our smoking habits as well. As part of the SmokeFreeBrain H2020 European Commission project, this study aims at elucidating the potential role of these technologies when used as an extra aid to quit smoking.Trial RegistrationClinicalTrials.gov NCT03553173; https://clinicaltrials.gov/ct2/show/record/NCT03553173 (Archived by WebCite at http://www.webcitation.org/74DuHypOW).International Registered Report Identifier (IRRID)PRR1-10.2196/12464
Highlights
BackgroundSmoking is considered the main cause of preventable illness and early deaths worldwide [1]
As part of the SmokeFreeBrain H2020 European Commission project, this study aims at elucidating the potential role of these technologies when used as an extra aid to quit smoking
As part of the SmokeFreeBrain H2020 European Commission project (Grant Agreement 681120) [16,17], this study aims at elucidating the potential role of the aforementioned technologies when used as an extra aid to quit
Summary
BackgroundSmoking is considered the main cause of preventable illness and early deaths worldwide [1]. 5.4 million people worldwide die each year of tobacco-related diseases, and it is estimated that by 2030 smoking will cause 8 to 10 million deaths a year, over 80% of them in low- and middle-income countries [3]. According to the World Health Organization, in 2025, about 22% of the adult populations of Europe will be regular smokers [4]. In Spain, in 2017, 22.08% of the population aged over 15 years smoked daily and 2.34% were occasional smokers. In Spain 25.58% of males and 18.76% of females are smokers; and 17.56% of young persons aged 15 to 24 years old have a tobacco habit, showing a relevant difference by sex (19.96% of males compared with 15.05% of females) [5]. The treatment usually prescribed to people who wish to quit smoking is a multidisciplinary intervention, combining both psychological advice and pharmacological therapy, since the application of both strategies significantly increases the chance of success in a quit attempt
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