Protocol for Past BP: a randomised controlled trial of different blood pressure targets for people with a history of stroke of transient ischaemic attack (TIA) in primary care

Fletcher et al. BMC Cardiovascular Disorders 2010, 10:37
http://www.biomedcentral.com/1471-2261/10/37

Table 1 Study inclusion and exclusion criteria

Inclusion criteria

On practice TIA/stroke register

Exclusion criteria

Systolic BP < 125 mmHg at baseline;

Already taking 3 or more anti-hypertensive agents; orthostatic hypotension (>20 mmHg postural change in systolic BP after 1 minute standing)

Patient already has a treatment target of 130 mmHg systolic BP specified

Unable to provide informed consent.

Insufficient corroborative evidence of stroke/TIA from medical record and patient interview

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 2^nd and 3^rd 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

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