Institute of Global Health, Faculty of Medicine, University of Geneva, 9 chemin des Mines, Campus Biotech, CH-1202, Geneva, Switzerland.
Addiction Medicine, Department of Psychiatry, Lausanne University Hospital and Lausanne University, Lausanne, Switzerland.
Trials. 2020 Jun 1;21(1):449. doi: 10.1186/s13063-020-04377-0.
Smartphone-based support can reach thousands of smokers and help those who would otherwise try to quit smoking by themselves with little chance of success. Nicotine medications double the chances of quitting smoking, but few smokers use them, and they often use them for too short a time and at an insufficient dose. It is therefore important to increase access to support for smoking cessation and compliance with nicotine therapy. The objectives of this study are to assess whether the Stop-Tabac application (app) is effective for smoking cessation and to examine whether the outcome is influenced by the personal characteristics of participants.
Trial design: this is a two-arm, parallel-group, superiority, individually randomized, "placebo" controlled trial in 5200 smokers, with follow up after 1 week, 1 month and 6 months. The participants are adult daily smokers (N = 5200) enrolled on the Internet, living in France or Switzerland. The intervention is the Stop-tabac fully-automated app for smartphones, which was launched in 2012 and continuously improved thereafter. It includes fact sheets; calculators of cigarettes not smoked, money saved, and years of life gained; an interactive "coach" that provides automated, individually tailored counseling messages based on the user's personal profile, sent regularly for 6 months; immediate feedback during episodes of craving and tobacco withdrawal symptoms; a discussion forum ("The Tribe") where participants provide and receive social support; a quiz that informs users in a playful way; and a module on nicotine therapy that includes personalized feedback and follow up. The outcome is self-reported smoking cessation after 6 months (no puff of tobacco in the past 4 weeks), and after 1 week and 1 month (no puff in the past 7 days). Participants will be randomized automatically based on a list of random numbers. Participants, assistants in charge of collecting follow-up data and data analysts will be blinded to allocation. Funding is provided by the Swiss National Science Foundation, CHF 194,942 (EUR 182,200, USD 200,700), grant 32003_179369. JFE's salary is paid by the University of Geneva, YK's salary is paid by the Lausanne University Hospitals.
There is little evidence from randomized trials of the impact of health apps in general and of smoking cessation apps in particular. This study will fill this gap.
ISRCTN Registry: ISRCTN11318024. Registered on 17 May 2018.
基于智能手机的支持可以接触到成千上万的吸烟者，并帮助那些单凭自身力量试图戒烟但成功率很低的人。尼古丁药物可使戒烟成功率增加一倍，但很少有吸烟者使用，且他们往往使用时间过短，剂量不足。因此，增加对戒烟支持和尼古丁治疗依从性的获取非常重要。本研究的目的是评估 Stop-Tabac 应用程序（app）是否对戒烟有效，并研究结果是否受参与者个人特征的影响。
试验设计：这是一项在 5200 名吸烟者中进行的为期 6 个月的、两臂、平行组、优势、个体随机、“安慰剂”对照试验，随访时间为 1 周、1 个月和 6 个月。参与者为成年每日吸烟者（N=5200），通过互联网招募，居住在法国或瑞士。干预措施是针对智能手机的完全自动化的 Stop-tabac 应用程序，该应用程序于 2012 年推出，并在此后不断改进。它包括情况说明书；未吸烟的香烟、节省的金钱和增加的寿命计算器；一个互动的“教练”，根据用户的个人资料提供自动、个性化的咨询信息，定期发送，持续 6 个月；在渴望和烟草戒断症状发作时提供即时反馈；一个讨论论坛（“部落”），参与者可以在其中提供和接收社会支持；一个以有趣的方式告知用户的测验；以及一个包括个性化反馈和随访的尼古丁治疗模块。主要结局为 6 个月后（过去 4 周内无吸烟）、1 周后（过去 7 天内无吸烟）和 1 个月后（过去 7 天内无吸烟）的自我报告戒烟情况。参与者将根据随机数列表自动随机分配。参与者、负责收集随访数据的助手和数据分析员将对分配情况进行盲法。资金由瑞士国家科学基金会提供，金额为 194942 瑞士法郎（182200 欧元、200700 美元），赠款号为 32003_179369。JFE 的工资由日内瓦大学支付，YK 的工资由洛桑大学附属医院支付。
关于健康应用程序的影响，特别是关于戒烟应用程序的影响，随机试验的证据很少。本研究将填补这一空白。
ISRCTN 注册处：ISRCTN81103112。于 2018 年 5 月 17 日注册。
