Table 2.
Timing and content of study assessments.
Baseline data: research nurse administered |
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Socio-demographic characteristics: |
Age; Ethnicity; Gender; Postcode |
Validation of stroke/transient ischaemic attack: |
Review of medical records with patient history |
Clinical measures: |
Six blood pressure (BP) measurements, calculating mean of 2nd and 3rd measurements and recording details of: arm used; arm circumference; BP cuff size; and time BP measurement started |
24 hour ambulatory BP recording |
Medical history |
Previous history of angina, myocardial infarction, heart failure, atrial fibrillation, CABG/angioplasty (balloon)/or stent, peripheral vascular disease, diabetes, chronic kidney disease. Current prescription medications. Smoking status and alcohol intake |
Patient questionnaires - self-completion |
Health related quality of life assessed by the SF-36 [20] and EQ-5 D [19] |
Disability assessed by the Modified Rankin Scale [26] |
Medication Adherence Report Schedule (MARS) for BP treatment [27] |
Symptoms/side effects questionnaire |
Patient questionnaire - research nurse completion |
Cognitive function assessed by the Mini Mental State [21] |
Eligibility and consent |
Review inclusion and exclusion criteria and record outcome of consent process |
Patient follow up for BP control |
GP appointment at any time patient BP medication review required |
Action taken to treat/monitor side effects |
Action taken to treat BP above target using study algorithm (see figure 1) |
Make appointment with practice nurse at appropriate interval (see figure 2) |
Practice nurse follow up - 1-3 month intervals |
Six BP readings, as per baseline data collection |
Side effects of BP medication |
Refer patient to GP or make further appointment with practice nurse (see figure 2) |
Patient follow up by research team |
Research nurse follow up - 6 and 12 months post randomisation |
Six BP readings, as per baseline data collection |
24 hour ambulatory BP recording (12 month f/u only) |
Check details of patient visits to GP and practice nurse |
Diagnosis of key medical conditions (as per baseline data collection) since baseline or the previous research nurse follow up |
All hospital admissions or outpatient visits since baseline or the previous research nurse follow up |
Record of medications introduced since baseline or the previous research nurse follow up |
Monitor compliance with repeat medication since baseline or previous research nurse follow up |
Completion of patient questionnaires, as per baseline data collection. |
Obtaining information on patients who died |
Records flagged at NHS central register |