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.
Albertyn, C. P.; Creese, B.; Guu, T.-W.; Kaur, S.; Kandangwa, P.; Vasconcelos Da Silva, M.; Aarsland, D.
Show abstract
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. Key pointsO_LISystematic, stakeholder-driven recruitment strategies improved care home dementia trial enrolment rates C_LIO_LIElectronic consent reduced time to consent from 34 days (in-person/postal) to just 5 days C_LIO_LIPre-existing research networks provided 83% of participants, demonstrating their critical value C_LIO_LIProtocol flexibility and PPI enabled rapid adaptation to COVID-19 and operational challenges C_LIO_LICombining eConsent, embedded infrastructure, and adaptive management overcame recruitment barriers C_LI
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