Pharmacists Intervention to Improve Hypertension Management in Primary Care

Not Applicable

Completed

• Conditions: Hypertension

• Registration Number: NCT03274531
• Lead Sponsor: Wilhelminenspital Vienna

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.

Study Timeline

• Study First Submitted: 2017-09-05
• Study First Submitted QC: 2017-09-05
• Study First Posted: 2017-09-07
• Study Start: 2017-10-16
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-05
• Last Update Posted: 2020-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 497

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Change in average systolic blood pressure (automated office blood pressure measurement)	20 weeks	Secondary endpoint

Trial Locations

Locations (52)

Buchen-Apotheke; 🇦🇹 Alland, Austria

Apotheke Bad Erlach; 🇦🇹 Bad Erlach, Austria

Kur-Apotheke; 🇦🇹 Bad Vöslau, Austria

Landschafts-Apotheke; 🇦🇹 Baden, Austria

Apotheke Am Goettweiger; 🇦🇹 Furth, Austria

Oetscherland-Apotheke; 🇦🇹 Gaming, Austria

Apotheke zum heiligen Georg; 🇦🇹 Gaweinstal, Austria

Apotheke Gmuend Neustadt; 🇦🇹 Gmünd, Austria

Apotheke Zum Auge Gottes; 🇦🇹 Gmünd, Austria

Marien-Apotheke; 🇦🇹 Gramatneusiedl, Austria

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