Pharmacists Intervention to Improve Hypertension Management in Primary Care

Hypertension Clinical Trial

— APOTHECARE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03274531
• Other study ID #: APOTHECARE
• Status: Completed
• Phase: N/A
• Start date: October 16, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2020
• Source: Wilhelminenspital Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 497
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• Referral of hypertensive patients to the attending physician
Immediate referral to the treating physician in case of elevated automated office blood pressure measurements

Locations

Country	Name	City	State
Austria	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	St. Georgs-Apotheke	Himberg
Austria	Apotheke Zu Maria Trost	Kirchberg am Wagram
Austria	Die Blaue Apotheke	Klosterneuburg
Austria	Stadt-Apotheke	Klosterneuburg
Austria	Kreis-Apotheke Zum schwarzen Adler	Korneuburg
Austria	Adler-Apotheke	Langenlois
Austria	Kamptal-Apotheke	Langenlois
Austria	Kronen-Apotheke	Lilienfeld
Austria	Apotheke Zur Madonna	Neunkirchen
Austria	Merkur-Apotheke	Neunkirchen
Austria	Triesting-Apotheke,	Oberwaltersdorf
Austria	Apotheke Zum heiligen Georg	Pitten
Austria	Apotheke Zur Mariahilf	Pöggstall
Austria	Apotheke Zum St. Nikolaus	Pottendorf
Austria	Apotheke Purgstall	Purgstall
Austria	Wallhof-Apotheke	Rannersdorf
Austria	Apotheke Sued	Sankt Poelten
Austria	Center Apotheke	Sankt Poelten
Austria	Hippolyt-Apotheke	Sankt Poelten
Austria	Rosen-Apotheke	Sankt Pölten
Austria	Stadt-Apotheke	Schrems
Austria	Linden-Apotheke	Seitenstetten Markt
Austria	Johannes-Apotheke	Traisen
Austria	Apotheke Zur Mutter Gottes	Traismauer
Austria	Activ Apotheke Tribuswinkel	Tribuswinkel
Austria	Adler Apotheke	Vienna
Austria	Apotheke Neu Kagran	Vienna
Austria	Arkaden Apotheke	Vienna
Austria	Birken Apotheke	Vienna
Austria	Friedrichs Apotheke	Vienna
Austria	Heilfried Apotheke	Vienna
Austria	Linden Apotheke	Vienna
Austria	Ludwigs Apotheke	Vienna
Austria	Rosen Apotheke	Vienna
Austria	Siebenbrunnen Apotheke	Vienna
Austria	St. Hubertus Apotheke	Vienna
Austria	Urania Apotheke	Vienna
Austria	Apotheke Zur Mariahilf	Wiener Neustadt
Austria	Bahnhof-Apotheke	Wiener Neustadt
Austria	Zehnerguertel-Apotheke	Wiener Neustadt
Austria	Apotheke Wimpassing	Wimpassing
Austria	Apotheke Zur heiligen Dreifaltigkeit	Wolkersdorf
Austria	Apotheke Zum schwarzen Adler	Zwettl Stadt
Austria	Kuenringer Apotheke	Zwettl Stadt

Sponsors (4)

Lead Sponsor	Collaborator
Wilhelminenspital Vienna	Association for the Promotion of Research in Atherosclerosis, Thrombosis and Vascular Biology, Institute for Cardiometabolic Diseases, Karl Landsteiner Society, Österreichische Apothekerkammer, Landesgeschäftsstelle Niederösterreich

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Primary endpoint	10 weeks
Secondary	Change in average systolic blood pressure (automated office blood pressure measurement)	Secondary endpoint	10 weeks
Secondary	Change in average systolic blood pressure (automated office blood pressure measurement)	Secondary endpoint	20 weeks
Secondary	Proportion of patients with systolic blood pressure <135 mmHg and diastolic blood pressure < 85 mmHg (automated office blood pressure measurement)	Secondary endpoint	20 weeks
Secondary	Proportion of patients with systolic blood pressure <135 mmHg and diastolic blood pressure < 85 mmHg (home blood pressure, mean of available readings)	Secondary endpoint, patients with available home blood pressure measurements	20 weeks