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首页> 外文期刊>JMIR Research Protocols >A Novel Smoking Cessation Smartphone App Integrated With a Mobile Carbon Monoxide Checker for Smoking Cessation Treatment: Protocol for a Randomized Controlled Trial
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A Novel Smoking Cessation Smartphone App Integrated With a Mobile Carbon Monoxide Checker for Smoking Cessation Treatment: Protocol for a Randomized Controlled Trial

机译：一种新型的戒烟智能手机应用程序，与用于移动戒烟治疗的移动式一氧化碳检查器集成：随机对照试验的方案

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Background Smoking cessation treatment programs have been widely available for patients with nicotine dependence. Despite intensive programs, the continuous abstinence rate (CAR) from weeks 9-12 is still about 50%. Recently, a smartphone app emerged as a novel tool for therapeutic interventions, including nicotine dependence. In this study, we developed “CureApp Smoking Cessation” (CASC), which consists of a smartphone app for patients and a Web-based patient management software for doctors with a mobile carbon monoxide (CO) checking device to improve the efficacy of the smoking cessation treatment. Objective This study aims to evaluate whether the CASC app is effective for individuals with nicotine dependence in addition to standard smoking cessation programs. Methods This will be a randomized, sham-controlled, open-label, multicenter trial. We will recruit participants with nicotine dependence, but are otherwise healthy adults. We will randomize and allocate participants 1:1 to the CASC treatment group or a control app group. Both groups will receive a 12-week standard smoking cessation program with pharmacotherapy and counseling. In addition, participants in the treatment group will have the CASC app installed on their smartphone, which will provide video tutorials, advice from an artificial intelligence nurse, a digital diary, and measure daily exhaled CO concentration. In contrast, the control group will have the control app installed on their smartphone, where all the functions that can potentially effect smoking cessation are removed. The primary outcome will be the biochemically validated CAR from weeks 9-24. The success of smoking cessation will be defined as self-reported continuous abstinence from weeks 9-24 and exhaled CO concentration ≤10 ppm both at weeks 12 and 24. The main secondary outcomes will be the CAR from weeks 9-12, weeks 9-52, and 7-day point prevalence abstinence at weeks 4, 8, 12, 24, and 52. Results We will recruit 580 participants with nicotine dependence from October 2017 to September 2018 or until the recruitment process is complete. The final 52-week follow-up will be completed in October 2019. We expect all trial results to be available by the end of 2019. The trial is funded by CureApp, Inc. Conclusions This is the first randomized controlled trial to evaluate the efficacy of CASC. We expect that CASC, in addition to standard smoking cessation programs, has a significantly higher CAR during weeks 9-24 than the control app.
机译：背景技术戒烟治疗方案已被广泛用于尼古丁依赖患者。尽管进行了密集的计划，但从9周到12周的持续禁欲率（CAR）仍约为50％。最近，智能手机应用程序成为治疗干预措施（包括尼古丁依赖性）的新型工具。在这项研究中，我们开发了“ CureApp戒烟”（CASC），该软件由用于患者的智能手机应用程序和用于医生的基于Web的患者管理软件组成，带有移动式一氧化碳（CO）检查设备，可提高吸烟效果戒烟治疗。目的这项研究旨在评估除标准戒烟计划外，CASC应用程序是否对尼古丁依赖者有效。方法这将是一项随机，假对照，开放标签，多中心试验。我们将招募具有尼古丁依赖性的参与者，但他们都是健康的成年人。我们将以1：1的比例随机分配参与者至CASC治疗组或对照组应用程序组。两组都将接受为期12周的标准戒烟计划，其中包括药物治疗和咨询服务。此外，治疗小组的参与者还将在其智能手机上安装CASC应用程序，该应用程序将提供视频教程，人工智能护士的建议，数字日记，并测量每日呼出的CO浓度。相比之下，对照组将在其智能手机上安装控制应用程序，在该应用程序上，所有可能影响戒烟的功能都将被删除。主要结果将是从9-24周开始经过生化验证的CAR。戒烟成功的定义为：第9-24周后自我报告的持续戒酒，第12周和第24周时呼出的CO浓度≤10ppm。主要的次要结局是9-12周，9-周的CAR在第4、8、12、24和52周的52天和7天的戒断率。结果从2017年10月到2018年9月，或者直到募集过程完成之前，我们将招募580名尼古丁依赖性参与者。最后的52周随访将于2019年10月完成。我们希望所有试验结果都能在2019年底获得。该试验由CureApp，Inc.资助。结论这是第一项评估疗效的随机对照试验。的CASC。我们预计，除了标准的戒烟计划外，CASC在9-24周内的CAR明显高于对照应用。

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