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Completed

NCT Number: NCT03274531

Pharmacists Intervention to Improve Hypertension Management in Primary Care

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Buchen-Apotheke, Alland, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Referral of hypertensive patients to the attending physician

Behavioral

Immediate referral to the treating physician in case of elevated automated office blood pressure measurements

Primary outcomes

  1. 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)

    Time frame: 10 weeks

    Primary endpoint

Secondary outcomes

  1. Change in average systolic blood pressure (automated office blood pressure measurement)

    Time frame: 10 weeks

    Secondary endpoint

  2. Change in average systolic blood pressure (automated office blood pressure measurement)

    Time frame: 20 weeks

    Secondary endpoint

  3. Proportion of patients with systolic blood pressure <135 mmHg and diastolic blood pressure < 85 mmHg (automated office blood pressure measurement)

    Time frame: 20 weeks

    Secondary endpoint

  4. Proportion of patients with systolic blood pressure <135 mmHg and diastolic blood pressure < 85 mmHg (home blood pressure, mean of available readings)

    Time frame: 20 weeks

    Secondary endpoint, patients with available home blood pressure measurements

Sponsors and collaborators

Lead sponsor

Wilhelminenspital Vienna

Other

Collaborators

  • Association for the Promotion of Research in Atherosclerosis, Thrombosis and Vascular Biology
  • Institute for Cardiometabolic Diseases, Karl Landsteiner Society
  • Österreichische Apothekerkammer, Landesgeschäftsstelle Niederösterreich

Registry information

Official study title

Pharmacists Intervention to Improve Hypertension Management in Primary Care (APOTHECARE): A Cluster-randomized Trial

Acronym: APOTHECARE

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 7, 2017
Registry last updated
Apr 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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