Title: TEST-BP: Trial of the Effectiveness and cost effectiveness of Self-monitoring and Treatment of Blood Pressure in secondary prevention following Stroke or Transient Ischaemic Attack (TIA)
Funder: Department of Health (England)

Abstract: Background Raised Blood Pressure (BP) is a major risk factor for stroke. People with Transient Ischaemic Attacks (TIA) and stroke are at higher risk of subsequent cardiovascular events compared to the general population, the highest risk being within the first year of the initial event. Reducing BP in this group has been shown to reduce subsequent events in those designated with “normal”, as well as high, BP levels. Good BP control is often difficult to assess and achieve but self-BP monitoring can lead to improved control and is increasingly common, many patients now owning monitors. It is unclear in stroke and TIA patients if self-monitoring with or without patient-led changes in BP therapy will be effective and cost effective compared to standard BP management and acceptable by patients. Aims In this Blinded End Point Randomised Controlled Trial (RCT) of six months duration the hypothesis tested will be that self BP monitoring, with or without supervised self-management of BP therapy, in those with TIA and stroke who require BP therapy will result in significantly better control (with more participants in these groups reaching target BP) compared to matched control group who have standard BP management. The study aims to test this hypothesis and examine the impact of these interventions on (1) BP control and BP target attainment, (2) surrogate marker of cardiovascular diseases (CVD) and 10 year estimated CVD risk, (3) cost effectiveness, and (4) feasibility, acceptability and patient satisfaction with the intervention. Plan of Investigation TIA or stroke patients requiring BP therapy (n=120) will be randomised into 3 groups; (A) standard BP management (no self monitoring), (B) self BP monitoring alone & (C) self monitoring with patient led treatment changes. In group C the study team will have direct access to the BP data (using telemetry), advising the patient on BP self-management using individually tailored treatment algorithms Groups B & C will self monitor BP for 7 days at 6 weeks, 3 & 5 months. 24 hour ambulatory BP levels will be measured at baseline and at the end of the study (6 month) as the gold standard. The primary outcome measure will be differences in 24 hour BP at 6 months between the groups. Acceptability, CVD markers, 10 year CVD risk, quality of life, and cost-effectiveness will be secondary outcomes. Potential Impact The trial will explore whether self-BP monitoring with or without supervised patient led changes in BP therapy, results in better BP control. Good BP control is associated with significant CVD risk reduction including stroke and TIA. Therefore, if the study findings show the intervention to be effective and cost effective, then this can be applied to the clinical setting for immediate patient benefit. As high BP is the major risk factor for stroke and cardiovascular diseases, this method can be applied to a wider population. This will reduce the morbidity, mortality and disease burden associated with cardiovascular and cerebrovascular diseases and will have potentially large impact for patients, clinicians and the NHS.


Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: STROKE;CARDIOVASCULAR