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| Name | Class |
|---|---|
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
| Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil | OTHER |
| Federal University of Health Science of Porto Alegre |
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High blood pressure is the main risk factor for cardiovascular disease worldwide,but its control rate is unsatisfactory. Home Blood Pressure Monitoring (HBPM) with automatic oscillometric devices and pharmaceutical care have been proposed as interventions to increase therapeutic compliance and to guide treatment decisions.
The purpose of this study is to evaluate the effect of HBPM and of pharmaceutical care in blood pressure control measured through 24h ambulatory blood pressure monitoring (ABPM).
Home Blood Pressure Monitoring (HBPM) and Pharmaceutical care have been proposed to improve therapeutic compliance and to guide treatment decisions, but their effects on BP control are still under debate.
This is a factorial randomized controlled trial including adult hypertensive patients under drug treatment but with office BP and 24h ABPM uncontrolled. Participants will be allocated to one of four groups: HBPM; HBPM and Pharmaceutical care; Pharmaceutical care; or control. All participants will receive usual care for high blood pressure. Participants will be followed for 60 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home Blood Pressure Monitoring | Experimental | Automatic oscillometric device for blood pressure measurement at home plus usual care. |
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| HBPM and Pharmaceutical care | Experimental | Automatic oscillometric device for blood pressure measurement at home and consultations with the pharmacists plus usual care. |
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| Pharmaceutical care | Active Comparator | Consultations with the pharmacists plus usual care. |
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| Control | Active Comparator | Usual care: participants are instructed to keep on their current antihypertensive medication and receive non-pharmacological recommendations for hypertension treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HBPM | Device | Automatic oscillometric device for home blood pressure measurement and usual care. |
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| Measure | Description | Time Frame |
|---|---|---|
| Delta values for 24h ABPM between baseline and final ABPM measurements | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Hypertension control | 60 days | |
| Average of systolic and diastolic blood pressure at the end of the study. | 60 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandra C. Fuchs, MD, PhD | Federal University of Rio Grande do Sul | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de ClÃnicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90035-903 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22134392 | Derived | Fuchs SC, Ferreira-da-Silva AL, Moreira LB, Neyeloff JL, Fuchs FC, Gus M, Wiehe M, Fuchs FD. Efficacy of isolated home blood pressure monitoring for blood pressure control: randomized controlled trial with ambulatory blood pressure monitoring - MONITOR study. J Hypertens. 2012 Jan;30(1):75-80. doi: 10.1097/HJH.0b013e32834e5a4f. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D010593 | Pharmaceutical Services |
| ID | Term |
|---|---|
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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| HBPM and Pharmaceutical care | Device | Automatic oscillometric device for blood pressure measurement at home and consultations with the pharmacists |
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| Pharmaceutical care | Behavioral | consultations with the pharmacists |
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| Usual care | Other | Consultation with the physician. |
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