176 The AVERT DOSE international trial: an update on the Irish experience

Abstract Background Mobility training is a complex intervention and recovery post-stroke is multidimensional. AVERT DOSE aims to define optimal early intervention regimens for people with mild to moderate ischaemic stroke. Methods AVERT DOSE (ACTRN:12619000557134) is an international randomised trial that will recruit >2,500 patients. Randomisation is to two groups according to stroke severity. Patients are then randomised to one of four mobility training regimens in each strata and the intervention is delivered for up to 14-days. Primary Outcome: Identification of the intervention regimen that results in higher proportion of favourable outcome at 3-months post-stroke. Results In Ireland, 4 sites are actively recruiting (1,2,3 and 7), one completing training (4) and two finalising ethical approval and contracts (5,6). Eighteen patients have been recruited to date in Ireland, and over 400 internationally. Trial set-up has proven complex with processes and requirements differing significantly across Irish sites. Time to ethics approval has ranged from 10-months to over 3-years. The novel status of this trial as a non-drug/medical device trial, but rather rehabilitation trial, had led to discussion in relation to the need for a trial EU representative. Staff recruitment and retention challenges have proven to be a significant barrier to recruitment in recent months. The development of an Irish Avert Dose group to collaboratively address challenges and provide peer support has proven very successful in both supporting sites to reach recruitment stage and throughout the stages of screening, recruitment, intervention and blind assessment. Conclusion Undertaking rehabilitation research against the backdrop of a global pandemic and increasing staffing challenges requires a determined, problem-solving approach. Irish sites have embraced this opportunity to answer an important stroke research question. Health and social care professionals have displayed innovation and competence in steering clinical research and this should improve future rehabilitation trial readiness. Trial recruitment is expected to gain pace as more Irish and international sites are approved.