Stroke
Conditions
Keywords
Blood pressure monitoring, self BP monitoring, self BP management
Brief summary
This blinded end point RCT will recruit high risk TIA and mild stroke patients (through the emergency TIA clinics and the acute stroke services at the Norfolk & Norwich University Hospital) who require anti-hypertensive therapy to examine the clinical and cost effectiveness of self-monitoring and self management of Blood Pressure compared to self monitoring alone and treatment as usual.
Detailed description
Research Question: In patients with a mild/moderate stroke or TIA who require drug treatment for BP control, does BP self-monitoring with or without patient-led management using a previously agreed treatment regime result in better BP control and patient satisfaction than standard GP based management? Planned sample size: 165 eligible participants distributed 1:1:1 between three groups. Group 1 (control) - treatment as usual (TAU). Group 2 - Self-monitoring only (Se-MO). Group 3 - Self-monitoring and self-management (Se-Man). Primary outcome: Number reaching target Ambulatory BP levels at follow-up and change in mean Ambulatory BP levels between baseline and follow-up at 6 months. Secondary outcomes: Number of changes in anti-hypertensive treatment during study Side-effects profiles and adverse events BP variability Pulse Wave Velocity (PWV) changes All cause and cause-specific mortality outcome at six month Recurrent TIA or stroke Incident CVD- stroke, TIA and myocardial infarction Costs Health related quality of life assessed Quality Adjusted Life Years (EQ-5D based) Patient satisfaction and experience of the process (qualitative data)
Interventions
OTHERSelf BP measurement
BP home measurement by patient, results to GP and GP alters treatment as per usual practice
OTHERStandard Care
Self BP measurement and patient management of anti-hypertensive treatment altering their own medication under supervision depending on home BP measurements
OTHERStandard BP management
GP to measure BP and manage BP control
OTHERTreatment
Contacted by the study nurse and depending on BP levels recorded the patient will alter their medication to achieve target BP levels.
Sponsors
University of East Anglia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged =/\> 18 years old with TIA or stroke of mild/moderate severity (NIHSS =\<15) who require BP management and are able and willing to undertake self BP measurement and guided alterations in therapy.
Exclusion criteria
* Those with terminal illness with life expectancy less than six months including end staged condition e.g. end stage COPD * Dementia or moderate to severe cognitive impairment * Those not receiving or expected to start anti-hypertensive therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean daytime/24 hour BP between baseline and follow-up using 24 hour BP recording and numbers reaching target BP | 6 months |
Countries
United Kingdom
Outcome results
None listed