title: 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: BACKGROUND
  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.
  
  
  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.
authors.affiliation: Center for Pharmacogenomics and Translational Research, Nemours Children's Specialty Care, 807 Children's Way, Jacksonville, FL 32207, USA. Electronic address: kathryn.blake@nemours.org.
authors.forename: Kathryn
authors.initials: K
authors.lastname: Blake
authors.affiliation: Center for Clinical Trials and Evidence Synthesis, Johns Hopkins University, 415 N Washington Street, Baltimore, MD 21205, USA. Electronic address: janet.holbrook@jhu.edu.
authors.forename: Janet T
authors.initials: JT
authors.lastname: Holbrook
authors.affiliation: Division of Psychiatry and Psychology, Nemours Children's Specialty Care, 807 Children's Way, Jacksonville, FL 32207, USA. Electronic address: holly.antal@nemours.org.
authors.forename: Holly
authors.initials: H
authors.lastname: Antal
authors.affiliation: Center for Clinical Trials and Evidence Synthesis, Johns Hopkins University, 415 N Washington Street, Baltimore, MD 21205, USA. Electronic address: dshade1@jhu.edu.
authors.forename: David
authors.initials: D
authors.lastname: Shade
authors.affiliation: Bioinformatics Core Facility, Nemours/Alfred I. duPont Hospital for Children, 1600 Rockland Road, Wilmington, DE 19803, USA. Electronic address: tim.bunnell@nemours.org.
authors.forename: H Timothy
authors.initials: HT
authors.lastname: Bunnell
authors.affiliation: Bioinformatics Core Facility, Nemours/Alfred I. duPont Hospital for Children, 1600 Rockland Road, Wilmington, DE 19803, USA. Electronic address: Suzanne.mccahan@nemours.org.
authors.forename: Suzanne M
authors.initials: SM
authors.lastname: McCahan
authors.affiliation: Johns Hopkins University School of Medicine, Baltimore, MD 21205, USA. Electronic address: rwise@jhmi.edu.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Wise
authors.affiliation: Bioinformatics Core Facility, Nemours/Alfred I. duPont Hospital for Children, 1600 Rockland Road, Wilmington, DE 19803, USA. Electronic address: chris.pennington@nemours.org.
authors.forename: Chris
authors.initials: C
authors.lastname: Pennington
authors.affiliation: Nemours Office of Human Subjects Protection, Nemours Foundation, 10140 Centurion Parkway North, Jacksonville, FL 32256, USA. Electronic address: paul.garfinkel@nemours.org.
authors.forename: Paul
authors.initials: P
authors.lastname: Garfinkel
authors.affiliation: Center for Health Care Delivery Science, Nemours Children's Specialty Care, 807 Children's Way, Jacksonville, FL 32207, USA. Electronic address: tim.wysocki@nemours.org.
authors.forename: Tim
authors.initials: T
authors.lastname: Wysocki
mesh_terms: D000293:Adolescent; D001249:Asthma / Q000188:drug therapy; D001993:Bronchodilator Agents / Q000627:therapeutic use; D002648:Child; D034201:Computers, Handheld; D003625:Data Collection / Q000379:methods*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D000068298:Fluticasone / Q000627:therapeutic use; D000068297:Fluticasone-Salmeterol Drug Combination / Q000627:therapeutic use; D006801:Humans; D007258:Informed Consent; D020407:Internet; D008297:Male; D019212:Multimedia; D012107:Research Design; D013147:Spirometry
chemical_list: D001993:Bronchodilator Agents; D000068297:Fluticasone-Salmeterol Drug Combination; D000068298:Fluticasone
keywords: Clinical trial; Informed consent; Internet; Mobile devices; Multimedia; Pediatric
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