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Use of Mobile Devices and Internet to Streamline An Asthma Clinical Trial (MICT)

The long-range goal of this project 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 project is a streamlined clinical trial that ran concurrently with a nearly identical traditional clinical trial, “Long-acting Beta Agonist Step Down Study” (LASST) allowing 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). We will measure comprehension of study information using an original questionnaire, the Research Participant Assessment and measure the efficiency of participant driven data entry from home into a Research Electronic Data Capture (REDCap) online database quality of spirometry with the EasyOne Plus handheld meter with remote coaching We will 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 also 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.

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    Page Last Updated: December 6, 2019

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