Efficacy of Home Blood Pressure Monitoring (MONITOR Study)
- Conditions
- Hypertension
- Registration Number
- NCT00921791
- Lead Sponsor
- Hospital de Clinicas de Porto Alegre
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 136
- Office BP ≥140/90 mm Hg
- 24h ABPM hypertension BP ≥130/80 mm Hg
- using at least one antihypertensive drug
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method Delta values for 24h ABPM between baseline and final ABPM measurements 60 days
- Secondary Outcome Measures
Name Time Method Hypertension control 60 days Average of systolic and diastolic blood pressure at the end of the study. 60 days
Trial Locations
- Locations (1)
Hospital de Clínicas de Porto Alegre
🇧🇷Porto Alegre, RS, Brazil
Hospital de Clínicas de Porto Alegre🇧🇷Porto Alegre, RS, Brazil