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首页> 外文期刊>JMIR Research Protocols >Using the Social-Local-Mobile App for Smoking Cessation in the SmokeFreeBrain Project: Protocol for a Randomized Controlled Trial
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Using the Social-Local-Mobile App for Smoking Cessation in the SmokeFreeBrain Project: Protocol for a Randomized Controlled Trial

机译：在SmokefreeBrain项目中使用社交本地移动应用程序戒烟：一项随机对照试验的协议

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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.
机译：背景技术吸烟被认为是全球可预防疾病和早期死亡的主要原因。通常对希望戒烟者开出的治疗方法是多学科干预，将心理咨询和药物治疗相结合，因为两种策略的应用会显着增加戒烟成功的机会。目的我们提供一项为期12个月的随机开放标签平行分组试验的研究方案，其主要目的是分析常规戒烟的心理治疗和联合戒烟应用程序（干预组）的疗效和效率。与单独的常规心理药物治疗（对照组）相比。方法目标人群包括就读于西班牙塞维利亚维尔根德尔罗西奥大学医院戒烟处的成年吸烟者（男性和女性）。社交本地移动是基于移动技术及其触发行为变化的能力的创新干预措施。该应用程序通过提供个性化的激励信息，身体活动监测，生活方式建议和分散注意力（迷你游戏）来帮助克服戒烟，是对戒烟的药物治疗的补充。通常的药物治疗包括安非他酮（Zyntabac 150毫克）或伐尼克兰（Champix 0.5毫克或1毫克）。主要结果将是（1）通过呼出一氧化碳和尿可替宁测试测得的一年戒烟率，以及（2）成本效益分析的结果，将以增量成本表示效率比。次要结果测量将是（1）药物治疗安全性分析，（2）患者健康相关生活质量分析，以及（3）健康生活方式和体育锻炼习惯的监测。结果使用医院的电子记录系统识别的548例患者中，我们排除了308例患者：188例拒绝参加，120例不符合纳入标准。共有240名患者入组：对照组（n = 120）将接受常规的心理药物治疗，而干预组（n = 120）将接受常规的心理药物治疗以及So-Lo-Mo应用程序。该项目于2015年6月获得资助。注册于2016年10月开始，于2017年10月完成。数据收集于2018年11月完成，数据分析正在进行中。初步结果有望在2019年初提交。结论社交网络和移动技术会影响我们的日常生活，因此也可能会影响我们的吸烟习惯。作为SmokeFreeBrain H2020欧洲委员会项目的一部分，本研究旨在阐明这些技术在用作戒烟的额外帮助时的潜在作用。

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