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


Robinson, Heather ORCID: 0000-0002-3566-2253, Appelbe, Duncan ORCID: 0000-0003-1493-0391, Dodd, Susanna ORCID: 0000-0003-2851-3337, Flowers, Susan ORCID: 0000-0002-9302-3492, Johnson, Sonia ORCID: 0000-0002-2219-1384, Jones, Steven H ORCID: 0000-0002-8801-5113, Mateus, Céu ORCID: 0000-0001-6219-219X, Mezes, Barbara ORCID: 0000-0002-0799-2423, Murray, Elizabeth ORCID: 0000-0002-8932-3695, Rainford, Naomi ORCID: 0000-0002-5876-3946 et al (show 4 more authors) (2019) Methodological Challenges in Web-Based Trials: Update and Insights From the Relatives Education and Coping Toolkit Trial (Preprint)

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Abstract

<sec> <title>UNSTRUCTURED</title> <p>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.</p> </sec> <sec> <title>INTERNATIONAL REGISTERED REPORT</title> <p>RR2-10.1136/bmjopen-2017-016965</p> </sec>

Item Type: Article
Uncontrolled Keywords: 4203 Health Services and Systems, 42 Health Sciences, 52 Psychology, Clinical Trials and Supportive Activities, Mental Health, Prevention, Minority Health, Clinical Research, Mental Illness, Mental health
Divisions: Faculty of Health & Life Sciences
Faculty of Health & Life Sciences > Inst. Population Health
Faculty of Health & Life Sciences > Clinical Directorate
Depositing User: Symplectic Admin
Date Deposited: 17 Apr 2025 15:42
Last Modified: 01 Jan 2026 19:18
DOI: 10.2196/preprints.15878
Open Access URL: https://mental.jmir.org/2020/7/e15878/
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URI: https://livrepository.liverpool.ac.uk/id/eprint/3191448
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