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

基本信息

  • 批准号:
    8669153
  • 负责人:
  • 金额:
    $ 45.67万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 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

项目摘要

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.
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。

项目成果

期刊论文数量(0)
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科研奖励数量(0)
会议论文数量(0)
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KATHRYN V BLAKE其他文献

KATHRYN V BLAKE的其他文献

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{{ truncateString('KATHRYN V BLAKE', 18)}}的其他基金

Improving Medication Adherence with Telehealthcare Medication Therapy Management to Change Health Outcomes in Adolescents and YoungAdults with Asthma (MATCH)
通过远程医疗药物治疗管理提高药物依从性,以改变患有哮喘的青少年和年轻成人的健康结果 (MATCH)
  • 批准号:
    9924619
  • 财政年份:
    2018
  • 资助金额:
    $ 45.67万
  • 项目类别:
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
  • 财政年份:
    2012
  • 资助金额:
    $ 45.67万
  • 项目类别:
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:
    8528714
  • 财政年份:
    2012
  • 资助金额:
    $ 45.67万
  • 项目类别:
Pharmacogenetics of Beta2-Agonists in Asthma
Beta2 激动剂治疗哮喘的药物遗传学
  • 批准号:
    7259436
  • 财政年份:
    2006
  • 资助金额:
    $ 45.67万
  • 项目类别:
Pharmacogenetics of Beta2-Agonists in Asthma
Beta2 激动剂治疗哮喘的药物遗传学
  • 批准号:
    7665365
  • 财政年份:
    2006
  • 资助金额:
    $ 45.67万
  • 项目类别:
Pharmacogenetics of Beta2-Agonists in Asthma
Beta2 激动剂治疗哮喘的药物遗传学
  • 批准号:
    7477820
  • 财政年份:
    2006
  • 资助金额:
    $ 45.67万
  • 项目类别:
Pharmacogenetics of Beta2-Agonists in Asthma
Beta2 激动剂治疗哮喘的药物遗传学
  • 批准号:
    7129241
  • 财政年份:
    2006
  • 资助金额:
    $ 45.67万
  • 项目类别:
Pharmacogenetics of Beta2-Agonists in Asthma
Beta2 激动剂治疗哮喘的药物遗传学
  • 批准号:
    7884486
  • 财政年份:
    2006
  • 资助金额:
    $ 45.67万
  • 项目类别:

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