Recruitment for dementia clinical trials in care homes: an evaluation of strategies employed in the Sativex® for the treatment of Agitation in Dementia (‘STAND’) Trial

Clinical trials in dementia face significant recruitment challenges, with only 1% of eligible participants typically engaged in research. The ‘Sativex for the Treatment of AgitatioN in Dementia’ (STAND) trial implemented innovative recruitment strategies to address these barriers. This study analyses the effectiveness of systematic recruitment approaches combining public outreach, targeted engagement, and electronic consent procedures. A mixed-methods approach incorporated patient and public involvement (PPI), stakeholder mapping, and iterative recruitment channel optimisation. Over 10 months, 98 participant enquiries were received, resulting in 53 participants consented and 29 enrolled (55% screen success rate). Electronic consent emerged as the preferred method (49% of consents), reducing time from first contact to signed informed consent from approximately 34 days (in-person/postal) to just 5 days. Pre-existing research networks provided 83% of participants, demonstrating their value. Despite falling short of the target 60 participants, primarily due to COVID-19 restrictions and drug supply challenges, recruitment exceeded targets in later months following implementation of PPI-informed strategies and protocol amendments. The study demonstrates that systematic recruitment approaches incorporating eConsent can effectively accelerate enrolment in dementia trials, while highlighting the importance of flexibility in protocol design and the value of embedded clinical research infrastructure within healthcare systems.