Exploring the Challenges of Recruiting Older People for a Randomised Trial Assessing the Feasibility of Treating White Coat Hypertension in the UK General Practices: A Mixed-methods Study

INTRODUCTION: There is a recognised association between white coat hypertension (WCH) and adverse cardiovascular outcomes in older adults. However, there is no consensus on the management of WCH in this group. The objective of the Hypertension in the Very Elderly Trial (HYVET-2) study was to assess the feasibility of randomising 100 patients > 75years with WCH from General Practice in the UK to treatment or usual care. The study did not randomise any patients. In this follow-up study, we sought to explore the reasons for not recruiting. METHODS: Furthermore, using a mixed-methods study design, staff from 29 General Practice (GP) sites and the Clinical Research Network (CRN) in Kent, Surrey, and Sussex (KSS), UK, were sent an online questionnaire about local research facilities and infrastructure, and HYVET-2 study methodology and target population demographics. RESULTS: Nineteen (19) individuals responded to the online questionnaires (15 primary care staff, 4 CRN staff). Moreover, using a framework approach, we identified six themes summarising challenges to HYVET-2 recruitment. These themes are established approaches of primary care towards managing WCH in older people, target patient demographics, study design complexity, patient- facing study documents, limited research resources in primary care, and identification of eligible patients using existing coding. CONCLUSION: Our experience showed that recruiting older people from primary care to a WCH study was not feasible. A national scoping survey amongst primary care physicians in the UK, as well as robust patient and public involvement (PPI) targeting older people with WCH, might improve recruitment in future studies addressing the management of WCH in older people.