Iacoviello Brian M, Steinerman Joshua R, Klein David B, Silver Theodore L, Berger Adam G, Luo Sean X, Schork Nicholas J
Click Therapeutics, Inc., New York, NY, United States.
Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York, NY, United States.
JMIR Mhealth Uhealth. 2017 Apr 25;5(4):e56. doi: 10.2196/mhealth.7226.
Tobacco smoking is the leading cause of preventable death in the United States, and the annual economic burden attributable to smoking exceeds US $300 billion. Obstacles to smoking cessation include limited access and adherence to effective cessation interventions. Technology can help overcome these obstacles; many smartphone apps have been developed to aid smoking cessation, but few that conform to the US clinical practice guideline (USCPG) have been rigorously tested and reported in the literature. Clickotine is a novel smartphone app for smoking cessation, designed to deliver the essential features of the USCPG and engineered to engage smokers by personalizing intervention components.
Our objective was to assess the engagement, efficacy, and safety of Clickotine in an initial, single-arm study. Outcomes measured were indicators of engagement with the smartphone app (number of app opens, number of interactions with the Clickotine program, and weeks active with Clickotine), cessation outcomes of 7- and 30-day self-reported abstinence from smoking, and negative health events.
We recruited US residents between 18 and 65 years of age who owned an iPhone and smoked 5 or more cigarettes daily for the study via online advertising. Respondents were prescreened for eligibility by telephone and, if appropriate, directed to a Web portal to provide informed consent, confirm eligibility, and download the Clickotine app. Participants completed study assessments via the online portal at baseline and after 8 weeks. Data were collected in Amazon S3 with no manual data entry, and access to all data was maximally restrictive, logged, and auditable.
A total of 416 participants downloaded the app and constituted the intention-to-treat (ITT) sample. On average, participants opened the Clickotine app 100.6 times during the 8-week study (median 69), logged 214.4 interactions with the Clickotine program (median 178), and remained engaged with Clickotine for 5.3 weeks (median 5). Among the ITT sample, 45.2% (188/416) reported 7-day abstinence and 26.2% (109/416) reported 30-day abstinence from smoking after 8 weeks. Completer analysis focused on 365 (87.7%) of the 416 enrolled participants who completed the 8-week questionnaire revealed that 51.5% (188/365) of completers reported 7-day abstinence and 29.9% (109/365) reported 30-day abstinence. Few adverse events, mostly consistent with nicotine withdrawal symptoms, were reported and overall no safety signal was detected.
In this initial single-arm trial, Clickotine users appeared to demonstrate encouraging indicators of engagement in terms of the number of app opens, number of program interactions, and continued engagement over time. Clickotine users reported encouraging quit rates while reporting few adverse events. Future research is warranted to assess Clickotine's efficacy in a randomized controlled trial.
Clinicaltrials.gov NCT02656745; https://clinicaltrials.gov/ct2/show/NCT02656745 (Archived by WebCite at http://www.webcitation.org/6peTT4x60).
吸烟是美国可预防死亡的首要原因，吸烟造成的年度经济负担超过3000亿美元。戒烟的障碍包括难以获得有效的戒烟干预措施以及难以坚持这些措施。技术有助于克服这些障碍；许多智能手机应用程序已被开发用于辅助戒烟，但符合美国临床实践指南（USCPG）的应用程序中，很少有经过严格测试并在文献中报道的。Clickotine是一款用于戒烟的新型智能手机应用程序，旨在提供USCPG的基本功能，并通过个性化干预组件来吸引吸烟者。
我们的目的是在一项初步的单臂研究中评估Clickotine的参与度、疗效和安全性。测量的结果包括与智能手机应用程序的参与度指标（应用程序打开次数、与Clickotine程序的交互次数以及使用Clickotine的活跃周数）、7天和30天自我报告的戒烟结果以及负面健康事件。
我们通过在线广告招募了年龄在18至65岁之间、拥有iPhone且每天吸烟5支或更多的美国居民参与该研究。通过电话对受访者进行资格预筛选，若合适，引导其进入网络门户以提供知情同意、确认资格并下载Clickotine应用程序。参与者在基线时和8周后通过在线门户完成研究评估。数据在亚马逊S3中收集，无需人工数据录入，并且对所有数据的访问具有最大限制，有记录且可审计。
共有416名参与者下载了该应用程序，构成了意向性分析（ITT）样本。在为期8周的研究中，参与者平均打开Clickotine应用程序100.6次（中位数为69次），与Clickotine程序记录了214.4次交互（中位数为178次），并使用Clickotine达5.3周（中位数为5周）。在ITT样本中，45.2%（188/416）报告在8周后7天戒烟，26.2%（109/416）报告30天戒烟。对完成8周问卷的416名登记参与者中的365名（87.7%）进行的完整分析显示，51.5%（188/365）的完成者报告7天戒烟，29.9%（109/365）报告30天戒烟。报告的不良事件很少，大多与尼古丁戒断症状一致，总体未检测到安全信号。
在这项初步的单臂试验中，就应用程序打开次数、程序交互次数以及随时间的持续参与度而言，Clickotine用户似乎表现出令人鼓舞的参与度指标。Clickotine用户报告的戒烟率令人鼓舞，同时报告的不良事件很少。有必要进行未来研究以在随机对照试验中评估Clickotine的疗效。
Clinicaltrials.gov NCT02656745；https://clinicaltrials.gov/ct2/show/NCT02656745（由WebCite存档于http://www.webcitation.org/6peTT4x60）
