TY - JOUR

T1 - Methodological Challenges in Web-Based Trials

T2 - Update and Insights From the Relatives Education and Coping Toolkit Trial

AU - Robinson, Heather

AU - Appelbe, Duncan

AU - Dodd, Susanna

AU - Flowers, Susan

AU - Johnson, Sonia

AU - Jones, Steven

AU - Mateus, Ceu

AU - Mezes, Barbara

AU - Murray, Elizabeth

AU - Rainford, Naomi

AU - Rosala-Hallas, Anna

AU - Walker, Andrew

AU - Williamson, Paula

AU - Lobban, Fiona

PY - 2020/7/17

Y1 - 2020/7/17

N2 - 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.

AB - 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.

KW - randomized controlled trial

KW - research design

KW - methods

KW - internet

KW - web

KW - mental health

KW - relatives

KW - carers

U2 - 10.2196/15878

DO - 10.2196/15878

M3 - Journal article

VL - 7

JO - JMIR Mental Health

JF - JMIR Mental Health

SN - 2368-7959

IS - 7

M1 - e15878

ER -