49 Recruiting sites to a multi-site randomised controlled trial of MiFoot

<h3>Background</h3> MiFoot is a multifactorial intervention aiming to reduce cardiovascular disease events in adults with current or previous Type 2 Diabetes-related Foot Ulcer Disease. MiFoot consists of a medical review and electrocardiogram (ECG) to determine exercise intensity, an individualised appointment to optimise medication, group structured self-management education and exercise sessions and a digital programme. <h3>Aim</h3> To recruit and set up sites in order to evaluate MiFoot as part of a multi-site randomised controlled trial. <h3>Methods</h3> Sites are being recruited via local Clinical Research Networks. Site set up includes specific protocol and intervention training. A recorded presentation is provided to support healthcare professionals (HCPs) conducting the individualised appointment. Group sessions are delivered by 2 facilitators, at least one being a HCP able to supervise exercise, and a 2-day training course is provided. <h3>Results</h3> So far, 3 sites have been recruited and training provided, one site is about to open, with talks with four more sites in progress. Excess treatment costs (ETCs), conflicting studies, complexities of setting up, and access to staff with adequate skill set to deliver all aspects of this multifactorial intervention have been barriers. Regular communication, opportunities to meet to discuss issues and problem-solve, being honest and realistic with the ETC process and potential recruitment rates, revising ETCs and providing sites with further opportunities to upskill have been key. <h3>Conclusion</h3> We may have overestimated the confidence and competence of some HCPs to deliver MiFoot in this high-risk population, which may in part be due to exercise not routinely discussed or offered in diabetes care and foot disease. However, there is greater than expected interest from potential participants. The study remains ongoing.