Efficacy of Home Blood Pressure Monitoring (MONITOR Study)

Hospital de Clinicas de Porto Alegre136 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

136

Conditions

Hypertension

Interventions

HBPMDEVICE

Automatic oscillometric device for home blood pressure measurement and usual care.

HBPM and Pharmaceutical careDEVICE

Automatic oscillometric device for blood pressure measurement at home and consultations with the pharmacists

Pharmaceutical careBEHAVIORAL

consultations with the pharmacists

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Office BP ≥140/90 mm Hg * 24h ABPM hypertension BP ≥130/80 mm Hg * using at least one antihypertensive drug Exclusion Criteria: * BP ≥ 180 / 110 mmHg) * major cardiovascular events in the last six months * acute or chronic diseases limiting the capacity to understand and to participate in the trial * masked hypertension * white-coat hypertension * secondary hypertension * pregnancy * breastfeeding * concurrent participation in another trial

Locations (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Outcomes

Primary Outcomes

Delta values for 24h ABPM between baseline and final ABPM measurements

Time frame: 60 days

Secondary Outcomes

Hypertension control

Time frame: 60 days

Average of systolic and diastolic blood pressure at the end of the study.

Time frame: 60 days

Data from ClinicalTrials.gov

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