title: Design Considerations in Development of a Mobile Health Intervention Program: The TEXT ME and TEXTMEDS Experience.
abstract: BACKGROUND
  Mobile health (mHealth) has huge potential to deliver preventative health services. However, there is paucity of literature on theoretical constructs, technical, practical, and regulatory considerations that enable delivery of such services.
  
  
  OBJECTIVE
  The objective of this study was to outline the key considerations in the development of a text message-based mHealth program; thus providing broad recommendations and guidance to future researchers designing similar programs.
  
  
  METHODS
  We describe the key considerations in designing the intervention with respect to functionality, technical infrastructure, data management, software components, regulatory requirements, and operationalization. We also illustrate some of the potential issues and decision points utilizing our experience of developing text message (short message service, SMS) management systems to support 2 large randomized controlled trials: TEXT messages to improve MEDication adherence & Secondary prevention (TEXTMEDS) and Tobacco, EXercise and dieT MEssages (TEXT ME).
  
  
  RESULTS
  The steps identified in the development process were: (1) background research and development of the text message bank based on scientific evidence and disease-specific guidelines, (2) pilot testing with target audience and incorporating feedback, (3) software-hardware customization to enable delivery of complex personalized programs using prespecified algorithms, and (4) legal and regulatory considerations. Additional considerations in developing text message management systems include: balancing the use of customized versus preexisting software systems, the level of automation versus need for human inputs, monitoring, ensuring data security, interface flexibility, and the ability for upscaling.
  
  
  CONCLUSIONS
  A merging of expertise in clinical and behavioral sciences, health and research data management systems, software engineering, and mobile phone regulatory requirements is essential to develop a platform to deliver and manage support programs to hundreds of participants simultaneously as in TEXT ME and TEXTMEDS trials. This research provides broad principles that may assist other researchers in developing mHealth programs.
authors.affiliation: The George Institute for Global Health, Camperdown, Australia.|Sydney Medical School, The University of Sydney, Sydney, Australia.|Westmead Hospital, Sydney, Australia.
authors.forename: Jay
authors.identifier: http://orcid.org/0000-0002-5509-6009
authors.initials: J
authors.lastname: Thakkar
authors.affiliation: Westmead Hospital, Sydney, Australia.|The University of Sydney, Sydney, Australia.
authors.forename: Tony
authors.identifier: http://orcid.org/0000-0002-6061-2784
authors.initials: T
authors.lastname: Barry
authors.affiliation: Sydney Medical School, The University of Sydney, Sydney, Australia.|Westmead Hospital, Sydney, Australia.
authors.forename: Aravinda
authors.identifier: http://orcid.org/0000-0002-7763-7806
authors.initials: A
authors.lastname: Thiagalingam
authors.affiliation: The George Institute for Global Health, Camperdown, Australia.|Sydney Medical School, The University of Sydney, Sydney, Australia.
authors.forename: Julie
authors.identifier: http://orcid.org/0000-0001-8707-5563
authors.initials: J
authors.lastname: Redfern
authors.affiliation: The University of Sydney, Sydney, Australia.
authors.forename: Alistair L
authors.identifier: http://orcid.org/0000-0001-7597-6372
authors.initials: AL
authors.lastname: McEwan
authors.affiliation: The George Institute for Global Health, Camperdown, Australia.|Sydney Medical School, The University of Sydney, Sydney, Australia.
authors.forename: Anthony
authors.identifier: http://orcid.org/0000-0003-1282-1896
authors.initials: A
authors.lastname: Rodgers
authors.affiliation: The George Institute for Global Health, Camperdown, Australia.|Sydney Medical School, The University of Sydney, Sydney, Australia.|Westmead Hospital, Sydney, Australia.
authors.forename: Clara K
authors.identifier: http://orcid.org/0000-0003-4693-0038
authors.initials: CK
authors.lastname: Chow
keywords: coronary artery disease; mHealth; mobile phone; text message