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。它是儿童期最常见的慢性疾病之一，也是造成旷课的主要原因。哮喘的临床试验仍然有很大的需求，但传统的临床试验是昂贵的，患者不参加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。本申请的长期目标是通过利用当前广泛使用的移动的电子通信和信息传输手段，将临床研究范式转变为更高效和更具成本效益的企业。这个创新项目是一个精简的临床试验，将与几乎相同的传统临床试验“长效β激动剂降压研究”（LASST）同时进行，这将允许直接比较精简和传统方法之间的过程和结果。12至17岁的哮喘儿童将随机参加本项目（简化试验）或LASST（传统试验）。在本提案中，我们将：使用原始问卷（研究参与者评估）测量对研究信息的理解（在Nemours开发），经过父母许可/同意过程，以动态交互式多媒体格式通过互联网发布（具体目标1）;测量使用iPad 2/3G从家中向研究电子数据采集（REDCap）在线数据库输入受试者驱动数据的效率，使用EasyOne Plus手持式呼吸机进行肺功能测定，并使用iPad 2/3G进行远程指导（特定目标2）;通过比较随机分配至本项目的儿童与LASST相比接受研究药物治疗12周后哮喘控制测试评分的差异，检验简化方法是否具有“试验效应”。我们将收集工作量报告数据，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”，并降低成本相比，LASST，方法将推广到包括成人和其他疾病的研究。 公共卫生相关性：哮喘儿童的临床试验费用昂贵，患者不愿参与。我们将测试以患者为中心并降低试验成本的创新试验设计。本申请提出了允许患者在家参与研究的新方法，旨在吸引当今移动的、电子连接的家庭，并降低进行研究的成本。

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. PUBLIC HEALTH RELEVANCE: Clinical trials in children with asthma are expensive and patients are reluctant to participate. We will test an innovative trial design that is patient centered and reduces trial costs. This application proposes new ways of allowing patients to be in a study from their home that are designed to appeal to today's mobile, electronically connected families and to reduce the costs of conducting a study.