Pharmacists Intervention to Improve Hypertension Management in Primary Care

NCT ID: NCT03274531

Last Updated: 2020-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

497 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-16

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, cluster randomized, controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Interventional Arm

Immediate referral of hypertensive patients to the attending physician based on automated office blood pressure measurements

Group Type EXPERIMENTAL

Referral of hypertensive patients to the attending physician

Intervention Type BEHAVIORAL

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

Observational Arm

Repeated automated office blood pressure measurements and referral of hypertensive patients to the attending physician after completion of the trial

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Referral of hypertensive patients to the attending physician

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Österreichische Apothekerkammer, Landesgeschäftsstelle Niederösterreich

UNKNOWN

Sponsor Role collaborator

Association for the Promotion of Research in Atherosclerosis, Thrombosis and Vascular Biology

OTHER

Sponsor Role collaborator

Institute for Cardiometabolic Diseases, Karl Landsteiner Society

UNKNOWN

Sponsor Role collaborator

Wilhelminenspital Vienna

OTHER

Sponsor Role lead

Responsible Party

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Miklos Rohla

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Miklos Rohla, MD

Role: PRINCIPAL_INVESTIGATOR

3rd Medical Department, Cardiology and Intensive Care Medicine, Wilhelminenhospital, Vienna, Austria

Thomas W Weiss, MD, PhD

Role: STUDY_CHAIR

3rd Medical Department, Cardiology and Intensive Care Medicine, Wilhelminenhospital, Vienna, Austria

Locations

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Buchen-Apotheke

Alland, , Austria

Site Status

Apotheke Bad Erlach

Bad Erlach, , Austria

Site Status

Kur-Apotheke

Bad Vöslau, , Austria

Site Status

Landschafts-Apotheke

Baden, , Austria

Site Status

Apotheke Am Goettweiger

Furth, , Austria

Site Status

Oetscherland-Apotheke

Gaming, , Austria

Site Status

Apotheke zum heiligen Georg

Gaweinstal, , Austria

Site Status

Apotheke Gmuend Neustadt

Gmünd, , Austria

Site Status

Apotheke Zum Auge Gottes

Gmünd, , Austria

Site Status

Marien-Apotheke

Gramatneusiedl, , Austria

Site Status

St. Georgs-Apotheke

Himberg, , Austria

Site Status

Apotheke Zu Maria Trost

Kirchberg am Wagram, , Austria

Site Status

Stadt-Apotheke

Klosterneuburg, , Austria

Site Status

Die Blaue Apotheke

Klosterneuburg, , Austria

Site Status

Kreis-Apotheke Zum schwarzen Adler

Korneuburg, , Austria

Site Status

Adler-Apotheke

Langenlois, , Austria

Site Status

Kamptal-Apotheke

Langenlois, , Austria

Site Status

Kronen-Apotheke

Lilienfeld, , Austria

Site Status

Apotheke Zur Madonna

Neunkirchen, , Austria

Site Status

Merkur-Apotheke

Neunkirchen, , Austria

Site Status

Triesting-Apotheke,

Oberwaltersdorf, , Austria

Site Status

Apotheke Zum heiligen Georg

Pitten, , Austria

Site Status

Apotheke Zum St. Nikolaus

Pottendorf, , Austria

Site Status

Apotheke Zur Mariahilf

Pöggstall, , Austria

Site Status

Apotheke Purgstall

Purgstall, , Austria

Site Status

Wallhof-Apotheke

Rannersdorf, , Austria

Site Status

Apotheke Sued

Sankt Pölten, , Austria

Site Status

Center Apotheke

Sankt Pölten, , Austria

Site Status

Hippolyt-Apotheke

Sankt Pölten, , Austria

Site Status

Rosen-Apotheke

Sankt Pölten, , Austria

Site Status

Stadt-Apotheke

Schrems, , Austria

Site Status

Linden-Apotheke

Seitenstetten Markt, , Austria

Site Status

Johannes-Apotheke

Traisen, , Austria

Site Status

Apotheke Zur Mutter Gottes

Traismauer, , Austria

Site Status

Activ Apotheke Tribuswinkel

Tribuswinkel, , Austria

Site Status

Urania Apotheke

Vienna, , Austria

Site Status

Siebenbrunnen Apotheke

Vienna, , Austria

Site Status

Heilfried Apotheke

Vienna, , Austria

Site Status

Ludwigs Apotheke

Vienna, , Austria

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Friedrichs Apotheke

Vienna, , Austria

Site Status

Linden Apotheke

Vienna, , Austria

Site Status

Adler Apotheke

Vienna, , Austria

Site Status

Arkaden Apotheke

Vienna, , Austria

Site Status

Rosen Apotheke

Vienna, , Austria

Site Status

Apotheke Neu Kagran

Vienna, , Austria

Site Status

St. Hubertus Apotheke

Vienna, , Austria

Site Status

Birken Apotheke

Vienna, , Austria

Site Status

Apotheke Zur Mariahilf

Wiener Neustadt, , Austria

Site Status

Bahnhof-Apotheke

Wiener Neustadt, , Austria

Site Status

Zehnerguertel-Apotheke

Wiener Neustadt, , Austria

Site Status

Apotheke Wimpassing

Wimpassing, , Austria

Site Status

Apotheke Zur heiligen Dreifaltigkeit

Wolkersdorf, , Austria

Site Status

Apotheke Zum schwarzen Adler

Zwettl Stadt, , Austria

Site Status

Kuenringer Apotheke

Zwettl Stadt, , Austria

Site Status

Countries

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Austria

References

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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.

Reference Type DERIVED
PMID: 36346543 (View on PubMed)

Other Identifiers

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APOTHECARE

Identifier Type: -

Identifier Source: org_study_id

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