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

描述(申请人提供)：哮喘是一种炎症性疾病，对全世界约3亿人和20%的儿童造成重大负担。它是儿童时期最常见的慢性病之一，也是导致旷课的主要原因。哮喘的临床试验仍然有很大的需求，但传统的临床试验费用高昂，患者提出的不参与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。这一应用的长期目标是通过利用目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率和更具成本效益的企业。这一创新项目是一个简化的临床试验，将与几乎相同的传统临床试验“长效Beta Agonist逐步下降研究”(LASST)同时进行，该研究将允许对简化和传统方法之间的过程和结果进行直接比较。12至17岁的哮喘儿童将被随机分成两组，分别参加这一项目(Streamline试验)或LASST(传统试验)。在这项提案中，我们将：使用原始调查问卷--研究参与者评估(在Nemour开发)，在家长许可/同意过程中以动态互动多媒体格式通过互联网传递(具体目标1)--衡量研究信息的理解力；使用iPad2/3G测量参与者驱动的数据从家里输入研究电子数据采集(RedCap)在线数据库的效率；使用EasyOne Plus手持式测定仪测量肺活量测量的质量，并使用iPad2/3G进行远程指导(具体目标2)；通过比较随机参加该项目的儿童与LASST儿童在12周研究药物治疗后哮喘控制测试分数的差异，来测试简化方法是否具有“试验效果”。我们将收集努力报告数据，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LASST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。

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.