Table 2

Timing and content of study assessments.

Baseline data: research nurse administered


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


Fletcher et al. BMC Cardiovascular Disorders 2010 10:37   doi:10.1186/1471-2261-10-37

Open Data