title: Implementation of clinical research trials using web-based and mobile devices: challenges and solutions.
abstract: With the increasing implementation of web-based, mobile health interventions in clinical trials, it is crucial for researchers to address the security and privacy concerns of patient information according to high ethical standards. The full process of meeting these standards is often made more complicated due to the use of internet-based technology and smartphones for treatment, telecommunication, and data collection; however, this process is not well-documented in the literature.
  
  
  
  The Smart Heart Trial is a single-arm feasibility study that is currently assessing the effects of a web-based, mobile lifestyle intervention for overweight and obese children and youth with congenital heart disease in Southwestern Ontario. Participants receive telephone counseling regarding nutrition and fitness; and complete goal-setting activities on a web-based application. This paper provides a detailed overview of the challenges the study faced in meeting the high standards of our Research Ethics Board, specifically regarding patient privacy.
  
  
  
  We outline our solutions, successes, limitations, and lessons learned to inform future similar studies; and model much needed transparency in ensuring high quality security and protection of patient privacy when using web-based and mobile devices for telecommunication and data collection in clinical research.
authors.affiliation: Faculty of Engineering, Western University, London, Canada.
authors.forename: Roy
authors.initials: R
authors.lastname: Eagleson
authors.affiliation: Department of Paediatrics, Western University, London, Canada.|Children's Health Research Institute, London, Canada.|Paediatric Cardiopulmonary research laboratory, London Health science centre, London, Canada.
authors.forename: Luis
authors.initials: L
authors.lastname: Altamirano-Diaz
authors.affiliation: Department of Paediatrics, Western University, London, Canada.
authors.forename: Alex
authors.initials: A
authors.lastname: McInnis
authors.affiliation: Department of Paediatrics, Western University, London, Canada.|Children's Health Research Institute, London, Canada.|Paediatric Cardiopulmonary research laboratory, London Health science centre, London, Canada.
authors.forename: Eva
authors.initials: E
authors.lastname: Welisch
authors.affiliation: School of Kinesiology, Western University, London, Canada.
authors.forename: Stefanie
authors.initials: S
authors.lastname: De Jesus
authors.affiliation: School of Kinesiology, Western University, London, Canada.
authors.forename: Harry
authors.initials: H
authors.lastname: Prapavessis
authors.affiliation: Department of Paediatrics, Western University, London, Canada.
authors.forename: Meghan
authors.initials: M
authors.lastname: Rombeek
authors.affiliation: Children's Health Research Institute, London, Canada.|Brescia University College, Western University, London, ON, Canada.
authors.forename: Jamie A
authors.initials: JA
authors.lastname: Seabrook
authors.affiliation: Department of Paediatrics, Western University, London, Canada.
authors.forename: Teresa
authors.initials: T
authors.lastname: Park
authors.affiliation: Department of Paediatrics, Western University, London, Canada. kambiz.norozi@lhsc.on.ca.|Children's Health Research Institute, London, Canada. kambiz.norozi@lhsc.on.ca.|Paediatric Cardiopulmonary research laboratory, London Health science centre, London, Canada. kambiz.norozi@lhsc.on.ca.|Department of Paediatric Cardiology and Intensive Care Medicine, Medical School Hannover, Hannover, Germany. kambiz.norozi@lhsc.on.ca.|Department of Paediatric Cardiology and Intensive Care Medicine, University of Goettingen, Goettingen, Germany. kambiz.norozi@lhsc.on.ca.|Department of Paediatrics, Division of Paediatric Cardiology, Western University, 800 Commissioners Rd E, PO Box 5010, London, ON, N6A 5W9, Canada. kambiz.norozi@lhsc.on.ca.
authors.forename: Kambiz
authors.identifier: 0000-0001-8806-6183
authors.initials: K
authors.lastname: Norozi
mesh_terms: D000293:Adolescent; D002648:Child; D002986:Clinical Trials as Topic / Q000379:methods; D016494:Computer Security / Q000706:statistics & numerical data*; D003219:Confidentiality / Q000941:ethics*; D003625:Data Collection; D006330:Heart Defects, Congenital / Q000628:therapy*; D015277:Hotlines / Q000706:statistics & numerical data*; D006801:Humans; D020407:Internet / Q000706:statistics & numerical data*; D009765:Obesity / Q000628:therapy*; D009864:Ontario; D000068997:Smartphone / Q000706:statistics & numerical data; D017216:Telemedicine / Q000941:ethics / Q000379:methods*
keywords: Obesity; Paediatric cardiology; Privacy; Security; Web-based technology; e-health