Use of Mobile Devices and the Internet to Streamline an Asthma Clinical Trial (MI

描述（由申请人提供）：哮喘是一种炎症性疾病，对全球约3亿人和20%的儿童造成重大负担。它是儿童最常见的慢性疾病之一，也是学校缺课的主要原因。对哮喘临床试验的需求仍然很大，但传统的临床试验费用昂贵，患者不参加临床试验的原因是额外的不便和后勤障碍。需要以患者为中心并降低试验成本的研究设计。该应用程序的长期目标是通过利用当前广泛使用的移动电子通信和信息传输手段，将临床研究范式转变为更有效和更具成本效益的企业。这一创新项目是一项简化的临床试验，将与一项几乎相同的传统临床试验“长效β受体激动剂降级研究”（LASST）同时进行，后者将允许直接比较简化方法和传统方法之间的过程和结果。12 - 17岁哮喘患儿将被随机分为本项目（精简试验）和LASST（传统试验）两组。在本提案中，我们将：使用原始问卷，研究参与者评估（在Nemours开发）来衡量研究信息的理解，遵循父母的许可/同意过程，以动态交互式多媒体格式在互联网上传递（具体目标1）；使用iPad2/3G测量参与者驱动的数据从家中输入研究电子数据捕获（REDCap）在线数据库的效率，以及使用iPad2/3G进行远程指导的EasyOne Plus手持式计量仪的肺活量测定质量（具体目标2）；通过比较随机分配到该项目的儿童在接受12周研究药物治疗后哮喘控制测试分数与LASST相比的差异，检验简化方法是否具有“试验效应”。我们将收集工作报告数据，以比较试验之间的人员成本。如果这个简化的项目缺乏“试验效果”，并且与last相比降低了成本，那么这些方法将推广到包括成人和其他疾病的研究中。

DESCRIPTION (provided by applicant): Asthma is an inflammatory disease that imposes a significant burden affecting an estimated 300 million persons and 20% of all children worldwide. It is one of the most common chronic diseases of childhood and is a leading cause of school absenteeism. There continues to be a great need for clinical trials in asthma but traditional clinical trials are expensive and reasons cited by patients for non-participation are extra inconvenience and logistical barriers. Study designs which are patient centered and reduce trial costs are needed. The long-range goal of this application is to transform the paradigm of clinical research into a more efficient and cost-effective enterprise by capitalizing upon current widely used mobile electronic means of communication and information transfer. This innovative project is a streamlined clinical trial that will run concurrently with a nearly identical traditioal clinical trial, "Long-acting Beta Agonist Step Down Study" (LASST) which will allow for direct comparison of processes and outcomes between the streamlined and traditional approach. Children 12 to 17 years old with asthma will be randomized to participate in this project (streamlined trial) or LASST (traditional trial). In this proposal we will: measure comprehension of study information using an original questionnaire, Research Participant Assessment (developed at Nemours), following a parental permission/assent process delivered over the internet in a dynamic interactive multi-media format (Specific Aim 1); measure the efficiency of participant driven data entry from home into a Research Electronic Data Capture (REDCap) online database using the iPad2/3G, and quality of spirometry with the EasyOne Plus handheld meter with remote coaching using the iPad2/3G (Specific Aim 2); test whether the streamlined approach has a "trial effect" by comparing the differences in Asthma Control Test scores following 12 weeks of study drug treatment in children randomized to this project compared to LASST. We will collect effort reporting data to compare personnel costs between the trials. If this streamlined project lacks a "trial effect" and reduces costs compared to LASST, the methodologies would be generalizable to studies which include adults and other diseases.