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 |