Hypertension
Conditions
Brief summary
Arterial hypertension is the single largest contributor to mortality world-wide, and only 30-50% of diagnosed and treated patients achieve their blood pressure goal. The APOTHECARE trial is designed to identify treated patients with uncontrolled hypertension in community pharmacies in order to improve blood pressure control through intensification of antihypertensive therapy.
Detailed description
Patients with medically treated arterial hypertension, who attend a pharmacy in order to obtain their antihypertensive medication are invited to participate in the trial. The main inclusion criteria is uncontrolled hypertension, as determined by an automated office blood pressure measurement at a threshold of 135/85 mmHg. Main exclusion criteria include a first-ever prescription of an antihypertensive agent, resistant hypertension, systolic blood pressure ≥ 180 mmHg and dialysis. Randomization occurs on the level of pharmacies (cluster randomization). Patients in the interventional arm are immediately referred to their treating physician for up-titration of antihypertensive therapy. Re-examination of automated automated office blood-pressure occurs in the respective pharmacy, and patients are referred to their treating physician again if required. These measures are accompanied by a structured and educational blood pressure record card. Patients in the observational arm undergo periodic automated office blood pressure measurements and are referred to their treating physician at the end of the trial in case of persistently uncontrolled blood pressure.
Interventions
BEHAVIORALReferral of hypertensive patients to the attending physician
Immediate referral to the treating physician in case of elevated automated office blood pressure measurements
Sponsors
Österreichische Apothekerkammer, Landesgeschäftsstelle Niederösterreich
Association for the Promotion of Research in Atherosclerosis, Thrombosis and Vascular Biology
Institute for Cardiometabolic Diseases, Karl Landsteiner Society
Wilhelminenspital Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, cluster randomized, controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Written informed consent * Age \> 18 years * Medically pre-treated arterial hypertension * Automated office blood pressure ≥ 135 mmHg systolic or ≥ 85 mmHg diastolic
Exclusion criteria
* First ever prescription of antihypertensive medication * First prescription of a new antihypertensive substance or dose adjustment * Prior therapy with 4 or more different antihypertensive substances * Systolic blood pressure ≥ 180 mmHg * Dialysis * Adherence to the study protocol not to be anticipated * Inclusion into the study at another study site
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with systolic blood pressure <135 mmHg and diastolic blood pressure < 85 mmHg at 10 weeks of follow-up (automated office blood pressure measurement) | 10 weeks | Primary endpoint |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in average systolic blood pressure (automated office blood pressure measurement) | 10 weeks | Secondary endpoint |
| Proportion of patients with systolic blood pressure <135 mmHg and diastolic blood pressure < 85 mmHg (automated office blood pressure measurement) | 20 weeks | Secondary endpoint |
| Proportion of patients with systolic blood pressure <135 mmHg and diastolic blood pressure < 85 mmHg (home blood pressure, mean of available readings) | 20 weeks | Secondary endpoint, patients with available home blood pressure measurements |
Countries
Austria
Outcome results
None listed