HypertensionAPOTHECARENCT03274531
Pharmacists Intervention to Improve Hypertension Management in Primary Care
A study testing Referral of hypertensive patients to the attending physician in people with Hypertension, run by Wilhelminenspital Vienna at 54 sites in Austria.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Referral of hypertensive patients to the attending physician
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 497 participants
- Where
- 54 sitesAustria
- Study dates
- 16 Oct 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent
- Age > 18 years
- Medically pre-treated arterial hypertension
- Automated office blood pressure ≥ 135 mmHg systolic or ≥ 85 mmHg diastolic
Who cannot join
- 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
Trial locations and contacts
54 sites in 1 country.
54 sites in 1 country
Austria54 sites
Buchen-Apotheke
Alland, 2534
Apotheke Bad Erlach
Bad Erlach, 2822
Kur-Apotheke
Bad Vöslau, 2540
Landschafts-Apotheke
Baden, 2500
Apotheke Am Goettweiger
Furth, 3511
Oetscherland-Apotheke
Gaming, 3292
Apotheke zum heiligen Georg
Gaweinstal, 2191
Apotheke Gmuend Neustadt
Gmünd, 3950
Apotheke Zum Auge Gottes
Gmünd, 3950
Marien-Apotheke
Gramatneusiedl, 2440
St. Georgs-Apotheke
Himberg, 2325
Apotheke Zu Maria Trost
Kirchberg am Wagram, 3470
Stadt-Apotheke
Klosterneuburg, 3400
Die Blaue Apotheke
Klosterneuburg, 3412
Kreis-Apotheke Zum schwarzen Adler
Korneuburg, 2100
Adler-Apotheke
Langenlois, 3550
Kamptal-Apotheke
Langenlois, 3550
Kronen-Apotheke
Lilienfeld, 3180
Apotheke Zur Madonna
Neunkirchen, 2620
Merkur-Apotheke
Neunkirchen, 2620
Triesting-Apotheke,
Oberwaltersdorf, 2522
Apotheke Zum heiligen Georg
Pitten, 2823
Apotheke Zur Mariahilf
Pöggstall, 3650
Apotheke Zum St. Nikolaus
Pottendorf, 2486
Apotheke Purgstall
Purgstall, 3251
Wallhof-Apotheke
Rannersdorf, 2324
Apotheke Sued
Sankt Pölten, 3100
Center Apotheke
Sankt Pölten, 3100
Hippolyt-Apotheke
Sankt Pölten, 3100
Rosen-Apotheke
Sankt Pölten, 3100
Stadt-Apotheke
Schrems, 3943
Linden-Apotheke
Seitenstetten Markt, 3353
Johannes-Apotheke
Traisen, 3160
Apotheke Zur Mutter Gottes
Traismauer, 3133
Activ Apotheke Tribuswinkel
Tribuswinkel, 2512
Urania Apotheke
Vienna, 1010
Siebenbrunnen Apotheke
Vienna, 1050
Heilfried Apotheke
Vienna, 1100
Ludwigs Apotheke
Vienna, 1110
Friedrichs Apotheke
Vienna, 1170
Linden Apotheke
Vienna, 1170
Adler Apotheke
Vienna, 1180
Arkaden Apotheke
Vienna, 1200
Rosen Apotheke
Vienna, 1210
Apotheke Neu Kagran
Vienna, 1220
St. Hubertus Apotheke
Vienna, 1220
Birken Apotheke
Vienna, 1230
Apotheke Zur Mariahilf
Wiener Neustadt, 2700
Bahnhof-Apotheke
Wiener Neustadt, 2700
Zehnerguertel-Apotheke
Wiener Neustadt, 2700
Apotheke Wimpassing
Wimpassing, 2632
Apotheke Zur heiligen Dreifaltigkeit
Wolkersdorf, 2120
Apotheke Zum schwarzen Adler
Zwettl Stadt, 3910
Kuenringer Apotheke
Zwettl Stadt, 3910
About this study
Official title: Pharmacists Intervention to Improve Hypertension Management in Primary Care (APOTHECARE): A Cluster-randomized Trial
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Referral of hypertensive patients to the attending physician
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Referral of hypertensive patients to the attending physicianBehavioural
Immediate referral to the treating physician in case of elevated automated office blood pressure measurements
| Study group | Role | What they receive |
|---|---|---|
| Interventional Arm | Experimental | Immediate referral of hypertensive patients to the attending physician based on automated office blood pressure measurements Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 weeks
Secondary outcomes (4)
Change in average systolic blood pressure (automated office blood pressure measurement)
Secondary endpoint
Measured: 10 weeks
Change in average systolic blood pressure (automated office blood pressure measurement)
Secondary endpoint
Measured: 20 weeks
Proportion of patients with systolic blood pressure <135 mmHg and diastolic blood pressure < 85 mmHg (automated office blood pressure measurement)
Secondary endpoint
Measured: 20 weeks
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
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start16 Oct 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, cluster randomized, controlled trial
- Masking
- None (open label)
- Enrolment
- 497 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wilhelminenspital Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Österreichische Apothekerkammer, Landesgeschäftsstelle Niederösterreich, Association for the Promotion of Research in Atherosclerosis, Thrombosis and Vascular Biology, Institute for Cardiometabolic Diseases, Karl Landsteiner Society
- Responsible party
- Principal investigator, Miklos Rohla, Wilhelminenspital Vienna
- Investigators
- Miklos Rohla, MD, Principal investigator, 3rd Medical Department, Cardiology and Intensive Care Medicine, Wilhelminenhospital, Vienna, AustriaThomas W Weiss, MD, PhD, Study chair, 3rd Medical Department, Cardiology and Intensive Care Medicine, Wilhelminenhospital, Vienna, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03274531
- Sponsor's protocol ID
- APOTHECARE
- Acronym
- APOTHECARE
- Status last verified
- Apr 2020
- First submitted
- 5 Sep 2017
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36346543
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacists Intervention to Improve Hypertension Management in Primary Care (APOTHECARE): A Cluster-randomized Trial
- ClinicalTrials.gov ID
- NCT03274531
- Acronym / sponsor ID
- APOTHECARE / APOTHECARE
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 497 participants (actual)
- Lead sponsor
- Wilhelminenspital ViennaUniversity, hospital or other
- Collaborators
- Österreichische Apothekerkammer, Landesgeschäftsstelle Niederösterreich, Association for the Promotion of Research in Atherosclerosis, Thrombosis and Vascular Biology, Institute for Cardiometabolic Diseases, Karl Landsteiner Society
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 7 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, cluster randomized, controlled trial
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm | Experimental | Behavioral: Referral of hypertensive patients to the attending physicianImmediate referral of hypertensive patients to the attending physician based on automated office blood pressure measurements |
| Observational Arm | No intervention | –Repeated automated office blood pressure measurements and referral of hypertensive patients to the attending physician after completion of the trial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Written informed consent
- Age > 18 years
- Medically pre-treated arterial hypertension
- Automated office blood pressure ≥ 135 mmHg systolic or ≥ 85 mmHg diastolic
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Referral of hypertensive patients to the attending physicianImmediate referral to the treating physician in case of elevated automated office blood pressure measurements | Behavioural | Interventional Arm |
Primary outcome
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
4 secondary outcomes
Change in average systolic blood pressure (automated office blood pressure measurement)
Time frame: 10 weeks
Change in average systolic blood pressure (automated office blood pressure measurement)
Time frame: 20 weeks
Proportion of patients with systolic blood pressure <135 mmHg and diastolic blood pressure < 85 mmHg (automated office blood pressure measurement)
Time frame: 20 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Derived from this study: PubMed 36346543Rohla 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.
- Individual participant dataSharing planned: No
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miklos Rohla, MD principal investigator
3rd Medical Department, Cardiology and Intensive Care Medicine, Wilhelminenhospital, Vienna, Austria
Thomas W Weiss, MD, PhD study chair
3rd Medical Department, Cardiology and Intensive Care Medicine, Wilhelminenhospital, Vienna, Austria
54 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Referral of hypertensive patients to the attending physician in people with Hypertension, run by Wilhelminenspital Vienna at 54 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03274531, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.