Abstract
BackgroundTobacco consumption is the most preventable cause of morbidity-mortality in the world. One aspect of smoking cessation that merits in-depth study is the use of an application designed for smartphones (app), as a supportive element that could assist younger smokers in their efforts to quit. To assess the efficacy of an intervention that includes the assistance of a smoking cessation smartphone application targeted to young people aged 18 to 30 years who are motivated to stop smoking.Methods/designCluster randomised clinical trial. Setting: Primary Health Care centres (PHCCs) in Catalonia. Analyses based on intention to treat. Participants: motivated smokers of 10 or more cigarettes per day, aged 18 to 30 years, consulting PHCCs for any reason and who provide written informed consent to participate in the trial. Intervention group will receive a 6-month smoking cessation programme that implements recommendations of a Clinical Practice Guideline, complemented with a smartphone app designed specifically for this programme. Control group will receive the usual care. The outcome measure will be abstinence at 12 months confirmed by exhaled-air carbon monoxide concentration of at least 10 parts per million at each control test.DiscussionTo our knowledge this is the first randomised controlled trial of a programme comparing the efficacy of usual care with a smoking cessation intervention involving a mobile app. If effective, the modality could offer a universal public health management approach to this common health concern.Trial registrationNCT01734421
Highlights
Tobacco consumption is the most preventable cause of morbidity-mortality in the world
To our knowledge this is the first randomised controlled trial of a programme comparing the efficacy of usual care with a smoking cessation intervention involving a mobile app
The objective of the present study is to evaluate the efficacy of an intervention that incorporates a smartphone app designed to reduce the prevalence of tobacco consumption in motivated young adults aged 18 to 30 years
Summary
The development of the proposed smartphone app, and subsequent evaluation of its effectiveness in our population, has the potential to contribute a useful tool for the smoking cessation efforts of young adults, as well as providing information about the effectiveness of smoking cessation interventions in a population that has not been studied in our environment. A limitation of the study is its open character Both patients and health care professionals will know that they are involved in the intervention, which might create a bias. The study will use random clustering of primary care centres to avoid the risk of contamination by taking geography into account. Multivariate analysis will be used to control for possible confounding factors. Another limitation is the difficulty of recruiting young patients who want to stop smoking. The multicentre study design, with 22 participating primary care centres and a long (18-month) recruitment period, is intended to ensure an adequate participant pool. All authors read and approved the final manuscript
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