A Novel Smoking Cessation Smartphone App Integrated With a Mobile Carbon Monoxide Checker for Smoking Cessation Treatment: Protocol for a Randomized Controlled Trial
A Novel Smoking Cessation Smartphone App Integrated With a Mobile Carbon Monoxide Checker for Smoking Cessation Treatment: Protocol for a Randomized Controlled Trial
复制标题
DOI：
10.2196/12252
复制
发表时间：
2019-02-01
影响因子：
1.7
通讯作者：
Fukunaga, Koichi
中科院分区：
文献类型：
--
作者：
Nomura, Akihiro;Tateno, Hiroki;Fukunaga, Koichi
背景：戒烟治疗计划已广泛用于尼古丁依赖患者。尽管有强化计划，但9-12周的持续戒烟率（CAR）仍约为50%。最近，一款智能手机应用程序成为治疗干预的新工具，包括尼古丁依赖。在这项研究中，我们开发了“CureApp Smoking Cessation”（CASC），它包括一个用于患者的智能手机应用程序和一个基于Web的患者管理软件，用于医生使用移动的一氧化碳（CO）检测设备，以提高戒烟治疗的效果。目的：本研究旨在评估除了标准戒烟之外，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。我们将招募尼古丁依赖的参与者，但他们是健康的成年人。我们将受试者按1：1的比例随机分配至CASC治疗组或对照应用组。两组都将接受为期12周的标准戒烟计划，包括药物治疗和咨询。此外，治疗组的参与者将在智能手机上安装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，对照组将在智能手机上安装控制应用程序，其中所有可能影响戒烟的功能都被删除。主要结局将是第9-24周的生化验证CAR。戒烟成功将定义为第9-24周自我报告的持续戒烟和呼出CO浓度
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