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      Efficacy of a mobile application for smoking cessation in young people: study protocol for a clustered, randomized trial

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          Abstract

          Background

          Tobacco 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/design

          Cluster 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.

          Discussion

          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. If effective, the modality could offer a universal public health management approach to this common health concern.

          Trial registration

          NCT01734421

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          Most cited references5

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          Propuestas de clase social neoweberiana y neomarxista a partir de la Clasificación Nacional de Ocupaciones 2011

          En España, la nueva Clasificación Nacional de Ocupaciones (CNO-2011), que ha variado sustancialmente respecto a la del año 1994, requiere la adaptación de la clase social ocupacional para ser utilizada en estudios de desigualdades en salud. En este artículo se presentan dos propuestas para medir la clase social: la nueva clasificación de clase social ocupacional (CSO-SEE12), basada en la CNO-2011, desde un enfoque neoweberiano, y una propuesta de clase social desde un enfoque neomarxista. La CSO-SEE12 se construye a partir de una revisión detallada de los códigos de la CNO-2011. Por su parte, la clase social neomarxista se establece a partir de variables sobre los bienes de capital, de organización y de cualificación. La CSO-SEE12 que se propone consta de siete clases sociales que pueden ser agrupadas en un número menor de categorías, según las necesidades del estudio. La clasificación neomarxista consta de 12 categorías, en las cuales las y los propietarios se dividen en tres categorías en función de los bienes de capital y las personas asalariadas en nueve categorías formadas a partir de los bienes de organización y cualificación. Estas propuestas se complementan con la proposición de una clasificación del nivel educativo que integra los diferentes planes de estudio en España, y ofrece las correspondencias con la Clasificación Internacional Normalizada de la Educación.
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            Txt2stop: a pilot randomised controlled trial of mobile phone-based smoking cessation support.

            To conduct a pilot randomised controlled trial of mobile phone-based smoking cessation support intervention for the UK population. Randomised controlled trial (txt2stop). Community. 200 participants responding to radio, poster and leaflet-based promotions regarding the trial. The response rate for the outcome measures planned for the main trial. Participants' qualitative responses to open-ended questions about the intervention content. Secondary outcomes were the outcomes planned for the main trial including the point prevalence of self-reported smoking at 4 weeks and pooled effect estimate for the short-term results for the STOMP and txt2stop trials. The response rate at 4 weeks was 96% and at 6 months was 92%. The results at 4 weeks show a doubling of self-reported quitting relative risk (RR) 2.08 (95% CI 1.11 to 3.89), 26% vs 12%. The pooled effect estimate combining txt2stop and a previous New Zealand trial in the short term is RR 2.18 (95% CI 1.79 to 2.65). Mobile phone-based smoking cessation is an innovative means of delivering smoking cessation support, which doubles the self-reported quit rate in the short term. It could represent an important, but as yet largely unused, medium to deliver age-appropriate public health measures. The long-term effect of this mobile phone-based smoking cessation support will be established by a large randomised controlled trial currently in recruitment.
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              Sample size calculations for cluster randomised trials. Changing Professional Practice in Europe Group (EU BIOMED II Concerted Action).

              Cluster randomised trials, in which groups of individuals are randomised, are increasingly being used in the health field. Adopting a clustered approach has implications for the design of such trials, and sample size calculations need to be inflated to accommodate for the clustering effect. Reliable estimates of intracluster correlation coefficients (ICCs) are required for robust sample size calculations to be made; however, little empirical evidence is available on their likely size, and on factors which influence their magnitude. The aim of this study was to generate empirical estimates of ICCs and to explore factors which may affect their magnitude. Empirical estimates of ICCs were calculated for both process variables and patient outcomes from a number of datasets of primary and secondary care implementation studies. Estimates of ICCs varied according to setting and type of outcome. Estimates of ICCs for process variables were higher than those for patient outcomes, and estimates derived from secondary care were higher than those from primary care. ICCs for process variables in primary care were of the order of 0.05-0.15, whilst those in secondary care were of the order of 0.3. Estimates for patient outcomes in primary care were generally lower than 0.05. Adopting cluster randomisation has implications for the design, size and analysis of clinical trials. This study gives an insight into the potential size of ICCs in primary and secondary care, and provides a practical guide to researchers to aid the planning of future studies in this area.
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                Author and article information

                Contributors
                Journal
                BMC Public Health
                BMC Public Health
                BMC Public Health
                BioMed Central
                1471-2458
                2013
                1 August 2013
                : 13
                : 704
                Affiliations
                [1 ]Centre d’Atenció Primària Bonavista, Direcció d’Atenció Primària Tarragona, Institut Català de la Salut, Tarragona, Spain
                [2 ]Unitat de Suport a la Recerca Tarragona - Reus, Institut Universitari d’Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Tarragona, Spain
                [3 ]Departamento Informática Primaria Camp de Tarragona, Institut Català de la Salut, Tarragona, Spain
                [4 ]Centre d’Atenció Primària Llibertat, Direcció d’Atenció Primària Tarragona, Institut Català de la Salut, Reus, Spain
                [5 ]Centre d’Atenció Primària Torreforta - La Granja, Direcció d’Atenció Primària Tarragona, Institut Català de la Salut, Tarragona, Spain
                [6 ]Departament d’Enginyeria Informàtica i Matemàtiques, Universitat Rovira i Virgili, Tarragona, Spain
                [7 ]Agència de Salut Pública de Catalunya. Departament de Salut. Generalitat de Catalunya, Barcelona, Spain
                Article
                1471-2458-13-704
                10.1186/1471-2458-13-704
                3750394
                23915067
                bbe4a2b8-da58-4a02-b830-d75795d4839c
                Copyright © 2013 Valdivieso-López et al.; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 4 June 2013
                : 26 July 2013
                Categories
                Study Protocol

                Public health
                randomized controlled trial,smoking cessation,technology,primary health care
                Public health
                randomized controlled trial, smoking cessation, technology, primary health care

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