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

使用移动设备和互联网简化哮喘临床试验 (MI

• 批准号: 8354300
• 负责人: KATHRYN V BLAKE
• 金额: $ 53.7万
• 依托单位: NEMOURS CHILDREN'S CLINIC
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-15 至 2016-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8354300
• 关键词: 17 year old; Absenteeism; Adult; Affect; Agonist; Asthma; Authorization documentation; Automobile Driving; Child; Childhood; Childhood Asthma; Chronic Disease; Clinical; Clinical Research; Clinical Trials; Clinical Trials Design; Communication; Comprehension; Conduct Clinical Trials; Consent; Data; Data Collection; Data Reporting; Databases; Devices; Disease; Electronics; Enrollment; Family; Goals; Home environment; Human Resources; Inflammatory; Institution; Internet; Measurement; Measures; Methodology; Methods; National Heart, Lung, and Blood Institute; Outcome; Paper; Participant; Patients; Performance; Persons; Pharmaceutical Preparations; Population; Procedures; Process; Questionnaires; Randomized; Research; Research Design; Running; Schools; Site; Spirometry; Testing; Time; Visit; Work; aged; cost; cost effective; design; electronic data; innovation; interest; meter; novel; patient oriented; patient population

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.

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。 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。我们将测试一种以患者为中心并降低试验成本的创新试验设计。这一应用程序提出了允许患者在家进行研究的新方法，旨在吸引当今移动、电子连接的家庭，并降低进行研究的成本。