Using the Social-Local-Mobile App for Smoking Cessation in the SmokeFreeBrain Project: Protocol for a Randomized Controlled Trial
Background: Smoking 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...
| Authors: | ; ; ; ; ; ; ; ; ; ; |
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| Format: | Article |
| Status: | Published version |
| Publication date: | 2018 |
| Country: | España |
| Institution: | Universidad de Sevilla (US) |
| Repository: | idUS. Depósito de Investigación de la Universidad de Sevilla |
| OAI Identifier: | oai:idus.us.es:11441/94435 |
| Online Access: | https://hdl.handle.net/11441/94435 https://doi.org/10.2196/12464 |
| Access Level: | Open access |
| Keyword: | Smoking cessation Mobile applications Randomized controlled trial Economic evaluation |
| _version_ | 1878733553324261376 |
|---|---|
| author | Jódar Sánchez, Francisco |
| author2 | Carrasco Hernández, Laura Núñez Benjumea, Francisco José Mesa González, Marco Antonio Moreno Conde, Jesús Parra Calderón, Carlos Luis Fernández Luque, Luis Hors Fraile, Santiago Civit Balcells, Antón Bamidis, Panagiotis D. Ortega Ruiz, Francisco |
| author2_role | author author author author author author author author author author |
| author_browse | Bamidis, Panagiotis D. Carrasco Hernández, Laura Civit Balcells, Antón Fernández Luque, Luis Hors Fraile, Santiago Jódar Sánchez, Francisco Mesa González, Marco Antonio Moreno Conde, Jesús Núñez Benjumea, Francisco José Ortega Ruiz, Francisco Parra Calderón, Carlos Luis |
| author_facet | Jódar Sánchez, Francisco Carrasco Hernández, Laura Núñez Benjumea, Francisco José Mesa González, Marco Antonio Moreno Conde, Jesús Parra Calderón, Carlos Luis Fernández Luque, Luis Hors Fraile, Santiago Civit Balcells, Antón Bamidis, Panagiotis D. Ortega Ruiz, Francisco |
| author_role | author |
| collection | idUS. Depósito de Investigación de la Universidad de Sevilla |
| description | Background: Smoking 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. Objective: We 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). Methods: The 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. Results: Of 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. Conclusions: Social 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. |
| eu_rights_str_mv | openAccess |
| format | article |
| id | ES_586cc120beb01a51c876ca2cdc43317e |
| institution | Universidad de Sevilla (US) |
| instname_str | Universidad de Sevilla (US) |
| network_acronym_str | ES |
| network_name_str | España |
| oai_identifier_str | oai:idus.us.es:11441/94435 |
| publishDate | 2018 |
| publishDateSort | 2018 |
| publisher | JMIR Publications |
| publisherStr | JMIR Publications |
| reponame_str | idUS. Depósito de Investigación de la Universidad de Sevilla |
| spelling | Using the Social-Local-Mobile App for Smoking Cessation in the SmokeFreeBrain Project: Protocol for a Randomized Controlled Trial Jódar Sánchez, Francisco Carrasco Hernández, Laura Núñez Benjumea, Francisco José Mesa González, Marco Antonio Moreno Conde, Jesús Parra Calderón, Carlos Luis Fernández Luque, Luis Hors Fraile, Santiago Civit Balcells, Antón Bamidis, Panagiotis D. Ortega Ruiz, Francisco Smoking cessation Mobile applications Randomized controlled trial Economic evaluation Background: Smoking 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. Objective: We 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). Methods: The 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. Results: Of 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. Conclusions: Social 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. JMIR Publications https://hdl.handle.net/11441/94435 https://doi.org/10.2196/12464 |
| spellingShingle | Using the Social-Local-Mobile App for Smoking Cessation in the SmokeFreeBrain Project: Protocol for a Randomized Controlled Trial Jódar Sánchez, Francisco Smoking cessation Mobile applications Randomized controlled trial Economic evaluation |
| status_str | publishedVersion |
| title | Using the Social-Local-Mobile App for Smoking Cessation in the SmokeFreeBrain Project: Protocol for a Randomized Controlled Trial |
| title_full | Using the Social-Local-Mobile App for Smoking Cessation in the SmokeFreeBrain Project: Protocol for a Randomized Controlled Trial |
| title_fullStr | Using the Social-Local-Mobile App for Smoking Cessation in the SmokeFreeBrain Project: Protocol for a Randomized Controlled Trial |
| title_full_unstemmed | Using the Social-Local-Mobile App for Smoking Cessation in the SmokeFreeBrain Project: Protocol for a Randomized Controlled Trial |
| title_short | Using the Social-Local-Mobile App for Smoking Cessation in the SmokeFreeBrain Project: Protocol for a Randomized Controlled Trial |
| title_sort | Using the Social-Local-Mobile App for Smoking Cessation in the SmokeFreeBrain Project: Protocol for a Randomized Controlled Trial |
| topic | Smoking cessation Mobile applications Randomized controlled trial Economic evaluation |
| topic_facet | Smoking cessation Mobile applications Randomized controlled trial Economic evaluation |
| url | https://hdl.handle.net/11441/94435 https://doi.org/10.2196/12464 |