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.
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.
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|Blake, Kathryn; Holbrook, Janet T; Antal, Holly et al. (2015) Use of mobile devices and the internet for multimedia informed consent delivery and data entry in a pediatric asthma trial: Study design and rationale. Contemp Clin Trials 42:105-18|