Use of mobile devices and the internet for multimedia informed consent delivery and data entry in a pediatric asthma trial: Study design and rationale

Abstract

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 non-inferior 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 and EasyOne spirometer for use during FaceTime visits and online twice daily symptom reporting during an 8-week run-in followed by a 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.

Trial registration: ClinicalTrials.gov NCT02061280.

Keywords: Clinical trial; Informed consent; Internet; Mobile devices; Multimedia; Pediatric.

Copyright © 2015 Elsevier Inc. All rights reserved.

Figures

Figure 1

Trial design for streamlined and traditional trials The relationship between the study design for the streamlined (MICT) and traditional (LASST) clinical trials. MICT, Mobile Devices and the Internet to Streamline an Asthma Clinical Trial; LASST, Long-acting Beta Agonist Step Down Study. Participants are randomized to either the streamlined or traditional trial design.

Figure 2

Details of visit type for streamlined trial design Sequence of onsite and FaceTime virtual study visits in the streamlined trial design. Only the first and final study visits occur at the study site.

Figure 3

Screenshot of consent video navigation page Streamlined trial consent web page demonstrating the 5 parts of the consent video. The sidebar material on the left side of the video image provides additional detail on the study and the tabs highlight as relevant parts of the video are played.

Figure 4

Screenshot of study webpage for morning and evening data entry Streamlined trial study site webpage for entering symptom report data each morning and evening. Additional information can be accessed by selecting the links on the left.

Figure 5

Screenshot of iPad dock icons The iPad dock icons including (left to right) study Gmail account, preloaded contact information for FaceTime appointments, video for using the EasyOne and conducting FaceTime appointments, login screen for the consent and study websites, Morning Report for entering PEF and medication use, Evening Report for entering symptoms and unscheduled medication use. PEF, peak expiratory flow.

Figure 6

Screenshot of evening report data entry screen Example of drop down questions that appear if the participant selects that they required unscheduled medical care on the Evening Report.

Figure 7

Screenshot of alert email to study coordinators Example of an email received by the study coordinator when a participant submits an Evening Report indicating unscheduled medical care. Any text that the participant includes in the Evening Report submission is included in the email.