Use of Mobile Devices and the Internet to Streamline an Asthma Clinical Trial
Status:
Completed
Trial end date:
2017-02-17
Target enrollment:
Participant gender:
Summary
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 traditional 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 iPad, and quality
of spirometry with the EasyOne Plus handheld meter with remote coaching using the iPad
(Specific Aim 2); test whether the streamlined approach has a "trial effect" by comparing the
differences in Asthma Control Test (ACT) 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.
Phase:
Phase 4
Details
Lead Sponsor:
Nemours Children's Clinic
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Treatments:
Fluticasone Fluticasone-Salmeterol Drug Combination Salmeterol Xinafoate Xhance