Use of Mobile Devices and the Internet to Streamline an Asthma Clinical Trial
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Introduction Phase III / IV clinical trials are expensive and time consuming and often suffer
      from poor enrollment and retention rates. Pediatric trials are particularly difficult because
      scheduling around the parent, participant and potentially other sibling schedules can be
      burdensome. We are evaluating using the internet and mobile devices to conduct the consent
      process and study visits in a streamlined pediatric asthma trial. Our hypothesis is that
      these study processes will be noninferior and will be less expensive compared to a
      traditional pediatric asthma trial.

      Materials/Methods Parents and participants, aged 12 through 17 years, complete the informed
      consent process by viewing a multi-media website containing a consent video and study
      material in the streamlined trial. Participants are provided an iPad with WiFi (wireless
      internet) and EasyOne spirometer for use during FaceTime visits and online twice daily
      symptom reporting during an 8-week run-in followed by 12-week study period. Outcomes are
      compared with participants completing a similarly designed traditional trial comparing the
      same treatments within the same pediatric health-system. After 8 weeks of open-label Advair
      250/50 twice daily, participants in both trial types are randomized to Advair 250/50, Flovent
      250, or Advair 100/50 given 1 inhalation twice daily. Study staff track time spent to
      determine study costs.

      Results Participants have been enrolled in the streamlined and traditional trials and
      recruitment is ongoing.

      Conclusions This project will provide important information on both clinical and economic
      outcomes for a novel method of conducting clinical trials. The results will be broadly
      applicable to trials of other diseases.
    

Intervention name(s): fluticasone/salmeterol 250/50 Dry Powder Inhaler; fluticasone/salmeterol 100/50 Dry Powder Inhaler; fluticasone 100mcg Dry Powder Inhaler
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive Advair Diskus 250/50 Dry Powder Inhaler, administered twice daily for 12 weeks after randomization; Participants will receive Advair Diskus 100/50 Dry Powder Inhaler administered twice daily for 12 weeks after randomization; Participants will receive Flovent Diskus 100mcg Dry Powder Inhaler administered twice daily for 12 weeks after randomization
Other intervention name(s): Advair Diskus; Advair Diskus; Flovent Diskus
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Asthma; Clinical Trial Design; Electronic Data Entry; Mobile Devices; Home Spirometry