Clinical trial NCT03274531: Pharmacists Intervention to Improve Hypertension Management in Primary Care
Official title: Pharmacists Intervention to Improve Hypertension Management in Primary Care (APOTHECARE): A Cluster-randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Wilhelminenspital Vienna
Sponsor class: OTHER
Collaborators: name: Österreichische Apothekerkammer, Landesgeschäftsstelle Niederösterreich
name: Association for the Promotion of Research in Atherosclerosis, Thrombosis and Vascular Biology
name: Institute for Cardiometabolic Diseases, Karl Landsteiner Society
First posted: 2017-09-07
Enrollment: 497
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, cluster randomized, controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: 10 weeks
Secondary outcomes:
measure: Change in average systolic blood pressure (automated office blood pressure measurement)
timeFrame: 10 weeks
measure: Change in average systolic blood pressure (automated office blood pressure measurement)
timeFrame: 20 weeks
measure: Proportion of patients with systolic blood pressure <135 mmHg and diastolic blood pressure < 85 mmHg (automated office blood pressure measurement)
timeFrame: 20 weeks
measure: Proportion of patients with systolic blood pressure <135 mmHg and diastolic blood pressure < 85 mmHg (home blood pressure, mean of available readings)
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Alland
country: Austria
facility: Buchen-Apotheke
city: Bad Erlach
country: Austria
facility: Apotheke Bad Erlach
city: Bad Vöslau
country: Austria
facility: Kur-Apotheke
city: Baden
country: Austria
facility: Landschafts-Apotheke
city: Furth
country: Austria
facility: Apotheke Am Goettweiger
city: Gaming
country: Austria
facility: Oetscherland-Apotheke
city: Gaweinstal
country: Austria
facility: Apotheke zum heiligen Georg
city: Gmünd
country: Austria
facility: Apotheke Gmuend Neustadt
city: Gmünd
country: Austria
facility: Apotheke Zum Auge Gottes
city: Gramatneusiedl
country: Austria
facility: Marien-Apotheke
city: Himberg
country: Austria
facility: St. Georgs-Apotheke
city: Kirchberg am Wagram
country: Austria
facility: Apotheke Zu Maria Trost
city: Klosterneuburg
country: Austria
facility: Stadt-Apotheke
city: Klosterneuburg
country: Austria
facility: Die Blaue Apotheke
city: Korneuburg
country: Austria
facility: Kreis-Apotheke Zum schwarzen Adler
city: Langenlois
country: Austria
facility: Adler-Apotheke
city: Langenlois
country: Austria
facility: Kamptal-Apotheke
city: Lilienfeld
country: Austria
facility: Kronen-Apotheke
city: Neunkirchen
country: Austria
facility: Apotheke Zur Madonna
city: Neunkirchen
country: Austria
facility: Merkur-Apotheke
city: Oberwaltersdorf
country: Austria
facility: Triesting-Apotheke,
city: Pitten
country: Austria
facility: Apotheke Zum heiligen Georg
city: Pottendorf
country: Austria
facility: Apotheke Zum St. Nikolaus
city: Purgstall
country: Austria
facility: Apotheke Purgstall
city: Pöggstall
country: Austria
facility: Apotheke Zur Mariahilf
city: Rannersdorf
country: Austria
facility: Wallhof-Apotheke
city: Sankt Poelten
country: Austria
facility: Apotheke Sued
city: Sankt Poelten
country: Austria
facility: Center Apotheke
city: Sankt Poelten
country: Austria
facility: Hippolyt-Apotheke
city: Sankt Pölten
country: Austria
facility: Rosen-Apotheke
city: Schrems
country: Austria
facility: Stadt-Apotheke
city: Seitenstetten Markt
country: Austria
facility: Linden-Apotheke
city: Traisen
country: Austria
facility: Johannes-Apotheke
city: Traismauer
country: Austria
facility: Apotheke Zur Mutter Gottes
city: Tribuswinkel
country: Austria
facility: Activ Apotheke Tribuswinkel
city: Vienna
country: Austria
facility: Urania Apotheke
city: Vienna
country: Austria
facility: Siebenbrunnen Apotheke
city: Vienna
country: Austria
facility: Heilfried Apotheke
city: Vienna
country: Austria
facility: Ludwigs Apotheke
city: Vienna
country: Austria
facility: Friedrichs Apotheke
city: Vienna
country: Austria
facility: Linden Apotheke
city: Vienna
country: Austria
facility: Adler Apotheke
city: Vienna
country: Austria
facility: Arkaden Apotheke
city: Vienna
country: Austria
facility: Rosen Apotheke
city: Vienna
country: Austria
facility: Apotheke Neu Kagran
city: Vienna
country: Austria
facility: St. Hubertus Apotheke
city: Vienna
country: Austria
facility: Birken Apotheke
city: Wiener Neustadt
country: Austria
facility: Apotheke Zur Mariahilf
city: Wiener Neustadt
country: Austria
facility: Bahnhof-Apotheke
city: Wiener Neustadt
country: Austria
facility: Zehnerguertel-Apotheke
city: Wimpassing
country: Austria
facility: Apotheke Wimpassing
city: Wolkersdorf
country: Austria
facility: Apotheke Zur heiligen Dreifaltigkeit
city: Zwettl Stadt
country: Austria
facility: Apotheke Zum schwarzen Adler
city: Zwettl Stadt
country: Austria
facility: Kuenringer Apotheke
Study officials:
affiliation: 3rd Medical Department, Cardiology and Intensive Care Medicine, Wilhelminenhospital, Vienna, Austria
name: Miklos Rohla, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 3rd Medical Department, Cardiology and Intensive Care Medicine, Wilhelminenhospital, Vienna, Austria
name: Thomas W Weiss, MD, PhD
role: STUDY_CHAIR
References:
citation: Rohla M, Haberfeld H, Tscharre M, Huber K, Weiss TW. Pharmacist interventions to improve blood pressure control in primary care: a cluster randomised trial. Int J Clin Pharm. 2023 Feb;45(1):126-136. doi: 10.1007/s11096-022-01452-1. Epub 2022 Nov 8.