Mobile Phone Application to Increase Tobacco Cessation Medication Adherence

描述（由申请人提供）：在美国，烟草是可预防疾病和死亡的主要原因。尽管存在有效的戒烟药物，但由于患者缺乏依从性，这些药物的影响会减弱。基于我们团队在使用技术改善烟草依赖循证治疗和提高哮喘药物依从性方面的专业知识，我们建议开发和评估一种交互式移动的健康应用程序（app），以帮助吸烟者正确使用戒烟药物。超过85%的美国成年人使用移动的手机，其中35%的手机上有应用程序。虽然我们的项目将集中在戒烟药物，这个应用程序将有广泛的适用性超越戒烟治疗。不坚持治疗慢性疾病，如高血压、高脂血症和糖尿病，与治疗结果不佳有关，包括住院率和医疗保健费用增加。在拟议项目中吸取的经验教训可以应用于其他类型药物的移动的健康应用程序的开发。在第一阶段，我们将设计、编程和评估一个用于苹果iPhone平台的移动的健康应用程序原型，该应用程序将帮助那些接受Chantix（R）（伐伦西林）治疗烟草依赖的吸烟者正确地坚持药物治疗方案。该应用程序将包括旨在解决药物不依从性的最常见原因的模块（例如，健忘、患者-提供者沟通不良、副作用、对药物治疗的益处缺乏信心等）。模块的示例包括提醒系统（提示剂量和再填充），用户与其处方医生或药剂师的直接链接（讨论剂量计划或副作用），以及有关伐尼克兰有效性和管理副作用的深入信息。我们将使用20个焦点小组参与者来完善应用程序的界面、功能和内容。我们将与10名参与者进行可用性测试，以帮助改进应用程序的功能和适用性。最后，我们将对应用程序的可行性和用户可接受性进行测试，有20名参与者。受试者内设计将评估参与者报告的产品可用性和满意度、用户报告的伐尼克兰依从性以及他们实际使用移动的应用程序的情况。依从性结局将使用多模式方法进行评估，包括处方续药率、移动的应用程序收集的日记数据和自我报告问卷。我们将通过移动网络界面评估用户的态度和满意度。将通过移动的应用程序自动收集计划使用情况。将在基线和入组后12周对受试者进行评估。在第二阶段，我们将扩展应用平台（例如，Android和Blackberry）和内容（例如，其他处方戒烟药物和非处方尼古丁替代产品），并通过随机试验评估全面应用。最终的移动的健康应用程序将通过多种渠道向吸烟者、医疗保健提供者、健康计划（基于私人和雇主）、药房福利经理和戒烟热线进行营销，包括应用程序商店、基于网络的戒烟计划、谷歌广告、社交媒体网站、直邮和电话。 公共卫生相关性：烟草使用在美国的流行提出了一个关键的公共卫生问题。使用药物来帮助吸烟者戒烟的情况正在增加。然而，这种治疗的有效性取决于其正确使用。拟议的研究旨在通过开发和评估交互式移动的手机健康应用程序来增加戒烟药物的依从性。

DESCRIPTION (provided by applicant): Tobacco is the leading cause of preventable disease and death in the U.S. Although effective tobacco cessation medications exist, the impact of these medications is diminished by lack of adherence by the patient. Based on our team's expertise in the use of technology to improve evidence-based treatment of tobacco dependence and improving asthma medication adherence, we propose to develop and evaluate an interactive mobile health application (app) for helping smokers to properly use tobacco cessation medication. Over 85% of U.S. adults use a mobile phone, and 35% of those have apps on their phones. Although our project will focus on tobacco cessation medication, this app would have broad applicability beyond tobacco cessation treatment. Non-adherence to treatment for chronic conditions such as hypertension, hyperlipidemia, and diabetes has been associated with poor treatment outcomes, including increasing hospitalization rates and health care costs. The lessons learned in the proposed project could be applied to the development of mobile health apps for other types of medication. During Phase I, we will design, program and evaluate a prototype mobile health application for the Apple iPhone platform that will assist smokers who are prescribed Chantix(R) (vareniciline) for treatment of tobacco dependence to properly adhere to the medication regimen. The app will include modules aimed at addressing the most common reasons for medication non-adherence (e.g., forgetfulness, poor patient-provider communications, side effects, lack of belief in benefits of medication, etc.). Examples of modules include reminder systems (to prompt dosing and refills), direct linkage from the user to their prescribing physician or pharmacist (to discuss dosing schedule or side effects), and in-depth information about the effectiveness of varenicline and managing side effects. We will use 20 focus group participants to refine the application's interface, functions, and content. We will conduct usability testing with 10 participants to assist in improving the app's functionality and suitability. Finally, we will conduct a test of the app's feasibility and user acceptability with 20 participants. A within-subjects design will evaluate participants' reported usability and satisfaction with the product, users' reported adherence to varenicline, and their actual use of the mobile app. Adherence outcomes will be evaluated using a multi-modal approach, including rate of prescription refills, mobile app collected diary data, and self-report questionnaires. We will assess attitudes and user satisfaction via a mobile-web interface. Program use will be collected automatically via the mobile app. Participants will be assessed at baseline and 12-weeks post-enrollment. During Phase II, we will expand the application platform (e.g., Android and Blackberry) and content (e.g., other prescription tobacco cessation medications and over- the-counter nicotine replacement products), and evaluate the full application via a randomized trial. The final mobile health app will be marketed to smokers, health care providers, health plans (private and employer- based), pharmacy benefit managers, and tobacco quit lines through multiple channels, including the App Store, web-based tobacco cessation programs, Google Ads, social media sites, direct mail and phone. PUBLIC HEALTH RELEVANCE: The prevalence of tobacco use in the United States presents a critical public health issue. The use of medications to assist smokers with quitting is increasing. However, the effectiveness of this treatment is predicated on its proper use. The proposed study seeks to increase the adherence to tobacco cessation medication by developing and evaluating an interactive mobile phone health application.