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Implementation of Clinical Research Trials Using Web-Based and Mobile Devices: challenges and solutions.
BMC medical research methodology
  • Roy Eagleson, Western University
  • Luis Altamirano-Diaz, Western University
  • Alex McInnis, Western University
  • Eva Welisch, Western University
  • Stefanie De Jesus, Western University
  • Harry Prapavessis, Western University
  • Meghan Rombeek, Western University
  • Jamie A Seabrook, Western University
  • Teresa Park, Western University
  • Kambiz Norozi, Western University
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BACKGROUND: 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.

RESULTS: 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.

CONCLUSION: 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.


Under Creative Commons Attribution License

Citation Information
Roy Eagleson, Luis Altamirano-Diaz, Alex McInnis, Eva Welisch, et al.. "Implementation of Clinical Research Trials Using Web-Based and Mobile Devices: challenges and solutions." BMC medical research methodology Vol. 17 Iss. 1 (2017)
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