A study exploring recruitment barriers to HYVET 2.
Research type
Research Study
Full title
A mixed methods study exploring the challenges of recruiting to a Phase IV, Multi-Centred, Open Label, Randomised Study Assessing the Cardiovascular Outcomes Following Treatment of White Coat Hypertension with Established Anti-Hypertensive Drugs versus Standard Care (no drug treatment) in the Very Elderly [HYVET 2 study] in primary care.
IRAS ID
284142
Contact name
Chakravarthi Rajkumar
Contact email
Sponsor organisation
University of Sussex
Duration of Study in the UK
0 years, 8 months, 21 days
Research summary
The HYVET 2 study was a multi-centre, open-label study assessing the feasibility of conducting a randomised controlled trial to treat white coat hypertension (WCH) in the very elderly (>75). The study was run from a number of GP Practices nationwide and was supported by the Primary Care Clinical Research Network (CRN). It was anticipated that one hundred (100) participants would be randomised for this feasibility study. Over a period of 17 months 29 sites were activated and 104 potentially eligible HYVET 2 participants were identified. Only 10 patients consented to be randomised; however, no patients were randomised, as none of these patients fulfilled inclusion criteria. \n\nIn order to learn from the HYVET 2 experience we plan to undertake a mixed methods process evaluation study of the challenges to conducting HYVET 2 in primary care. The study will consist of an online questionnaire aiming to recruit 50 participants (GPs, research delivery staff and Local Clinical Research Network Lead Facilitators) to explore the barriers to recruitment. The qualitative element will include semi-structured interviews with up to 15 clinicians (GPs/research nurses) and 5-12 patients who were identified and invited to participate in the study. This approach which will yield rich data explaining some of the barriers to engaging an older person in research.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
20/YH/0253
Date of REC Opinion
9 Oct 2020
REC opinion
Further Information Favourable Opinion