Title: A self-management approach to optimisation of hypertension associated with chronic kidney disease in secondary care
Funder: Department of Health and Social Care

Abstract: Background Chronic Kidney Disease (CKD) affects 10-15% of the adult population globally and its prevalence is increasing. CKD is associated with progression to end stage kidney disease (ESKD) and significant increase in cardiovascular risk and mortality. Persons with CKD therefore typically manifest multimorbidity. Control of high blood pressure (BP) is the most important therapeutic intervention to improve outcomes. Nevertheless, there is widespread evidence that current BP targets are not met, and a new lower systolic BP target ofResearch Questions In a large UK cohort of participants with CKD cared for in secondary care, how well is BP controlled and what characteristics are associated with poorly controlled BP? In the same cohort, how does BP control relate to outcomes at 5 years - specifically progression to ESKD and death? Is an intervention based on BP self-monitoring with self-titration to a lower systolic BP to Is this self-management approach acceptable to participants and what factors enable or prevent adoption of the intervention?Aims & Objectives Analyse baseline data from the NURTuRE-CKD study to investigate levels of BP control and identify participant characteristics associated with suboptimal BP control. Establish how BP control correlates with outcomes at 5 years of ESKD and death in the NURTuRE-CKD cohort. In a feasibility randomised controlled trial (RCT) establish whether an intervention based on home-monitoring and self-titration of medication previously evaluated in primary care can be adopted in participants with CKD in secondary care. Use semi-structured interviews to investigate participant experience of the intervention Workpackages 1&2Statistical analysis of data from the NURTuRE-CKD multicentre cohort study (n=3000) and analysis of 5 year outcome data for ESKD progression and death provided by the UK Renal Registry. Workpackage 3 A feasibility RCT with 100 participants with CKD recruited from secondary care nephrology clinics at a single site and randomised to either usual care or a self-management and self-titration of BP medications. Study visits will be conducted at baseline, 6 and 12 months with blood, urine, standardised BP measurement and an illness perceptions questionnaire (IPQ-R) completed. Adherence to the intervention, completion of study visits, recruitment and adverse events will be assessed as feasibility outcomes. Workpackage 4 A qualitative sub-study recruiting 15 participants from the intervention arm to complete a semi-structured interview assessing acceptability of the intervention and barriers and enablers to adoption. Anticipated impact and dissemination The cohort study will identify the unmet treatment need in a UK population and explore the relationship between hypertension and outcomes. The feasibility study will establish whether a definitive RCT of self-management is feasible and will explore patient experience. Results will be disseminated via conferences, publications, renal networks and patient groups.

Lay abstract: Chronic kidney disease (CKD) is a long-term disease resulting in the kidneys not functioning properly. Kidneys filter the blood, removing toxins and waste products, to keep us healthy. Most people don't develop symptoms until kidney function is very low - this is called end stage kidney disease (ESKD) and requires dialysis treatment or kidney transplant. Any drop in function (assessed by blood and urine tests) is associated with increased risk of heart disease, strokes, ESKD and early death. One of the most important ways to reduce this risk is measuring people's blood pressure (BP) regularly and lowering high BP (often associated with CKD) to the optimal level with tablets. Achieving this in practice may be difficult because people with CKD usually require more tablets than others. Research has shown that BP in people with CKD is often above the recommended level. New international CKD guidelines recommending a lower BP target of less than 120 mmHg (based on research including mainly people with mild CKD) make this more challenging. It is unclear whether this is achievable in people with more severe CKD and whether it will be associated with negative effects, including excessively low BP, falls or reduced kidney function. The aims of this fellowship are to: Explore how well BP is controlled in patients with CKD in the UK and how the risk of developing ESKD or of early death is related to the level of BP. Establish whether people measuring BP at home, supported to increase BP tablets themselves, is achievable without negative effects in people with CKD looked after in hospital clinics Establish whether a questionnaire to measure the way people view and understand their CKD works as part of the study. Use interviews with participants to obtain feedback on the intervention study.This will be achieved through: Analysis of information from a UK-wide cohort study of 3000 participants with CKD. We will analyse their BP levels, comparing these to targets and establishing whether there are clear factors related to poor BP control. This might enable us to identify people more likely to have poor control in the future. Using information on outcomes over five years, the relationship between the level of BP control and the risk of negative outcomes like developing ESKD and early death will be examined. A study recruiting 100 participants with CKD and high BP from Derby outpatient kidney clinics. Fifty participants will be randomly assigned to start measuring their BP at home and after discussion with a doctor, follow an agreed plan to increase the doses of, or add additional BP medications themselves if their BP is over an agreed threshold for two consecutive months (one week of readings each month). The remaining fifty will receive normal outpatient care. Participants will be followed up for 12 months, with research visits at recruitment, 6 and 12 months. Blood and urine tests, a BP check and a questionnaire will be completed at each visit. Ten to fifteen people who have self-managed their BP in this study (intervention group) will be invited to be interviewed about their experience of the study.Patients have been involved in the design of both the interview and the home BP studies and will continue to advise throughout. Three patient representatives will be invited to join the steering group overseeing the study. Outcomes will be communicated through conferences, publications and local patient and public involvement groups. Information from the feasibility study and interviews will be used to design a larger trial of self-managed BP designed to test the benefits and possible negative effects in more detail.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: RENAL AND UROGENITAL