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