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（由申请人提供）：哮喘是一种炎症性疾病，给全世界估计有 3 亿人和 20% 的儿童带来沉重负担。它是儿童期最常见的慢性疾病之一，也是缺课的主要原因。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高效、更具成本效益的企业。该创新项目是一项简化的临床试验，将与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，这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 至 17 岁患有哮喘的儿童将被随机参加该项目（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（由 Nemours 开发）衡量对研究信息的理解，并遵循家长许可/同意流程，以动态交互式多媒体格式通过互联网提供（具体目标 1）；使用 iPad2/3G 测量参与者驱动的数据从家里输入到研究电子数据采集 (REDCap) 在线数据库的效率，以及使用 EasyOne Plus 手持式仪表测量肺活量测定的质量，并使用 iPad2/3G 进行远程指导（具体目标 2） ;通过比较随机分配到该项目的儿童与 LASST 相比接受 12 周研究药物治疗后哮喘控制测试分数的差异，测试简化方法是否具有“试验效果”。我们将收集工作报告数据来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，那么该方法将可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，而且患者不愿意参加。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。该应用程序提出了允许患者在家中参与研究的新方法，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。