NCT03274531

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
497

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable hypertension

Geographic Reach
1 country

54 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 7, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

October 16, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

April 7, 2020

Status Verified

April 1, 2020

Enrollment Period

2.2 years

First QC Date

September 5, 2017

Last Update Submit

April 5, 2020

Conditions

Outcome Measures

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)

    Primary endpoint

    10 weeks

Secondary Outcomes (4)

  • Change in average systolic blood pressure (automated office blood pressure measurement)

    10 weeks

  • Change in average systolic blood pressure (automated office blood pressure measurement)

    20 weeks

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

    20 weeks

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

    20 weeks

Study Arms (2)

Interventional Arm

EXPERIMENTAL

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

Behavioral: Referral of hypertensive patients to the attending physician

Observational Arm

NO INTERVENTION

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

Interventions

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

Interventional Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent
  • Age \> 18 years
  • Medically pre-treated arterial hypertension
  • Automated office blood pressure ≥ 135 mmHg systolic or ≥ 85 mmHg diastolic

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (54)

Buchen-Apotheke

Alland, 2534, Austria

Location

Apotheke Bad Erlach

Bad Erlach, 2822, Austria

Location

Kur-Apotheke

Bad Vöslau, 2540, Austria

Location

Landschafts-Apotheke

Baden, 2500, Austria

Location

Apotheke Am Goettweiger

Furth, 3511, Austria

Location

Oetscherland-Apotheke

Gaming, 3292, Austria

Location

Apotheke zum heiligen Georg

Gaweinstal, 2191, Austria

Location

Apotheke Gmuend Neustadt

Gmünd, 3950, Austria

Location

Apotheke Zum Auge Gottes

Gmünd, 3950, Austria

Location

Marien-Apotheke

Gramatneusiedl, 2440, Austria

Location

St. Georgs-Apotheke

Himberg, 2325, Austria

Location

Apotheke Zu Maria Trost

Kirchberg am Wagram, 3470, Austria

Location

Stadt-Apotheke

Klosterneuburg, 3400, Austria

Location

Die Blaue Apotheke

Klosterneuburg, 3412, Austria

Location

Kreis-Apotheke Zum schwarzen Adler

Korneuburg, 2100, Austria

Location

Adler-Apotheke

Langenlois, 3550, Austria

Location

Kamptal-Apotheke

Langenlois, 3550, Austria

Location

Kronen-Apotheke

Lilienfeld, 3180, Austria

Location

Apotheke Zur Madonna

Neunkirchen, 2620, Austria

Location

Merkur-Apotheke

Neunkirchen, 2620, Austria

Location

Triesting-Apotheke,

Oberwaltersdorf, 2522, Austria

Location

Apotheke Zum heiligen Georg

Pitten, 2823, Austria

Location

Apotheke Zum St. Nikolaus

Pottendorf, 2486, Austria

Location

Apotheke Zur Mariahilf

Pöggstall, 3650, Austria

Location

Apotheke Purgstall

Purgstall, 3251, Austria

Location

Wallhof-Apotheke

Rannersdorf, 2324, Austria

Location

Apotheke Sued

Sankt Pölten, 3100, Austria

Location

Center Apotheke

Sankt Pölten, 3100, Austria

Location

Hippolyt-Apotheke

Sankt Pölten, 3100, Austria

Location

Rosen-Apotheke

Sankt Pölten, 3100, Austria

Location

Stadt-Apotheke

Schrems, 3943, Austria

Location

Linden-Apotheke

Seitenstetten Markt, 3353, Austria

Location

Johannes-Apotheke

Traisen, 3160, Austria

Location

Apotheke Zur Mutter Gottes

Traismauer, 3133, Austria

Location

Activ Apotheke Tribuswinkel

Tribuswinkel, 2512, Austria

Location

Urania Apotheke

Vienna, 1010, Austria

Location

Siebenbrunnen Apotheke

Vienna, 1050, Austria

Location

Heilfried Apotheke

Vienna, 1100, Austria

Location

Ludwigs Apotheke

Vienna, 1110, Austria

Location

Friedrichs Apotheke

Vienna, 1170, Austria

Location

Linden Apotheke

Vienna, 1170, Austria

Location

Adler Apotheke

Vienna, 1180, Austria

Location

Arkaden Apotheke

Vienna, 1200, Austria

Location

Rosen Apotheke

Vienna, 1210, Austria

Location

Apotheke Neu Kagran

Vienna, 1220, Austria

Location

St. Hubertus Apotheke

Vienna, 1220, Austria

Location

Birken Apotheke

Vienna, 1230, Austria

Location

Apotheke Zur Mariahilf

Wiener Neustadt, 2700, Austria

Location

Bahnhof-Apotheke

Wiener Neustadt, 2700, Austria

Location

Zehnerguertel-Apotheke

Wiener Neustadt, 2700, Austria

Location

Apotheke Wimpassing

Wimpassing, 2632, Austria

Location

Apotheke Zur heiligen Dreifaltigkeit

Wolkersdorf, 2120, Austria

Location

Apotheke Zum schwarzen Adler

Zwettl Stadt, 3910, Austria

Location

Kuenringer Apotheke

Zwettl Stadt, 3910, Austria

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Miklos Rohla, MD

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

    PRINCIPAL INVESTIGATOR
  • Thomas W Weiss, MD, PhD

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, cluster randomized, controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 5, 2017

First Posted

September 7, 2017

Study Start

October 16, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

April 7, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations