Investigating the use of a one-page infographic to improve recruitment and retention to the BASIL+ randomised controlled trial:A Study Within a Trial (SWAT)

Background: Low participant recruitment and retention rates are a significant barrier to successful Randomised Controlled Trials (RCTs). A Study Within A Trial (SWAT) is an effective way to explore which trial delivery methods may be useful for improving participant recruitment and retention rates. Infographics are a useful information delivery tool that may improve participants’ understanding of the trial and thus improve recruitment or retention rates. This SWAT was embedded within the Behavioural Activation in Social Isolation (BASIL+) RCT. BASIL+ was delivered during the Covid-19 pandemic and evaluated the clinical and cost-effectiveness of a brief psychological intervention (Behavioural Activation) to mitigate depression and loneliness in older adults with multiple long-term health conditions. Methods: Twelve research sites were randomly allocated 1:1 to either the SWAT intervention group (participant information included a one-page infographic) or the SWAT control group (participant information did not include a one-page infographic). The primary outcome was the recruitment rate to the BASIL+ trial. The secondary outcomes were the number of expressions of interest in the trial and the follow-up retention rate at 3 months post-randomisation. Results were compared for each group using a mixed-effect logistic regression model with trial site as a random effect. The cost-effectiveness of the SWAT intervention was also evaluated. Results: Despite a small additional cost (£0.13) per participant, there was no evidence that participant recruitment, expressions of interest or retention was significantly affected by the inclusion of the one-page infographic. Conclusion: Our results suggest that the inclusion of an infographic alongside the participant information sheet may not be the best way to improve recruitment and retention rates for RCTs. However, infographics continue to be effective tools for information delivery in healthcare settings, and further research is needed to explore their use in RCTs. Keywords: Recruitment; Retention; Randomised Controlled Trial; Study Within a Trial; Infographic; Methods; SWAT; Participant Information; PIS