Fully-Online, Interoperable Clinical Trial Management System for Multi-Interventional RCT: Maintain Your Brain Digital Platform

Jeewani Anupama Ginige, Christos Boulamatsis, Megan Heffernan, Juan Carlos San Jose, Igor Chuprov, Tiffany Chau, Anthony Maeder, Michael Valenzuela, Maria Fiatarone Singh, Yorgi Mavros, Yian Noble, Sue Radd-Vagenas, Yareni Guerrero, Nidhi Jain, Fiona O'Leary, Nicole Kochan, Henry Brodaty

    Research output: Chapter in Book/Report/Conference proceedingChapterpeer-review

    Abstract

    Maintain Your Brain (MYB)i is a randomised controlled trial (RCT) of multiple online interventions designed to target modifiable risk factors for Alzheimer's disease and dementia. Traditional clinical trial management systems (CTMS) requirements consist of features such as management of the study, site, subject (participant), clinical outcomes, external and internal requests, education, data extraction and reporting, security, and privacy. In addition to fulfilling these traditional requirements, MYB has a specific set of features that needs to be fulfilled. These specific requirements include: (i) support for multiple interventions within a study, (ii) flexible interoperability options with third-party software providers, (iii) study participants being able to engage in online activities via web-based interfaces throughout the trial (from screening to follow-up), (iv) ability to algorithmically personalize trial activities based on the needs of the participant, and (v) the ability to handle large volumes of data over a long period. This paper outlines how the existing CTMSs fall short in meeting these specific requirements. The presented system architecture, development approach and lessons learned in the implementation of the MYB digital platform will inform researchers attempting to implement CTMSs for trials comparable to MYB in the future.

    Original languageEnglish
    Title of host publicationInformation Technology Based Methods for Health Behaviours
    Subtitle of host publicationSelected Papers from Global Telehealth 2019
    EditorsAnthony J. Maeder, Stephanie Champion, Carly Moores, Rebecca Golley
    PublisherIOS PRESS
    Pages97-112
    Number of pages16
    Volume268
    ISBN (Electronic)9781643680590
    ISBN (Print)9781643680583
    DOIs
    Publication statusPublished - 2 Mar 2020

    Publication series

    NameStudies in Health Technology and Informatics
    Volume268
    ISSN (Print)0926-9630
    ISSN (Electronic)1879-8365

    Keywords

    • Clinical Trial Management System
    • digital trial platform
    • interoperability
    • multi-intervention trials
    • online-interventions

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