Methodological Challenges in Web-Based Trials: Update and Insights From the Relatives Education and Coping Toolkit Trial

Heather Robinson, Duncan Appelbe, Susanna Dodd, Susan Flowers, Sonia Johnson, Steven H Jones, Céu Mateus, Barbara Mezes, Elizabeth Murray, Naomi Rainford, Anna Rosala-Hallas, Andrew Walker, Paula Williamson, Fiona Lobban

Research output: Contribution to journalArticle

Abstract

There has been a growth in the number of web-based trials of web-based interventions, adding to an increasing evidence base for their feasibility and effectiveness. However, there are challenges associated with such trials, which researchers must address. This discussion paper follows the structure of the Down Your Drink trial methodology paper, providing an update from the literature for each key trial parameter (recruitment, registration eligibility checks, consent and participant withdrawal, randomization, engagement with a web-based intervention, retention, data quality and analysis, spamming, cybersquatting, patient and public involvement, and risk management and adverse events), along with our own recommendations based on designing the Relatives Education and Coping Toolkit randomized controlled trial for relatives of people with psychosis or bipolar disorder. The key recommendations outlined here are relevant for future web-based and hybrid trials and studies using iterative development and test models such as the Accelerated Creation-to-Sustainment model, both within general health research and specifically within mental health research for relatives. Researchers should continue to share lessons learned from conducting web-based trials of web-based interventions to benefit future studies.

International Registered Report Identifier (IRRID): RR2-10.1136/bmjopen-2017-016965
Original languageEnglish
Article numbere15878
JournalJMIR Mental Health
Volume7
Issue number7
DOIs
Publication statusPublished - 17 Jul 2020

Bibliographical note

This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Mental Health, is properly cited. The complete bibliographic information, a link to the original publication on http://mental.jmir.org/, as well as this copyright and license information must be included.

Keywords

  • randomized controlled trial
  • research design
  • methods
  • internet
  • web
  • mental health
  • relatives
  • carers

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