Efficacy of Home Blood Pressure Monitoring (MONITOR Study)

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Other: Usual care; Device: HBPM and Pharmaceutical care; Behavioral: Pharmaceutical care; Device: HBPM

• 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.

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2009-01
• Status Verified: 2009-06
• Study Completion: 2009-06
• Study First Submitted: 2009-06-15
• Study First Submitted QC: 2009-06-15
• Last Update Submitted: 2009-06-15
• Study First Posted: 2009-06-16
• Last Update Posted: 2009-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Control	Usual care	Usual care: participants are instructed to keep on their current antihypertensive medication and receive non-pharmacological recommendations for hypertension treatment.
HBPM and Pharmaceutical care	HBPM and Pharmaceutical care	Automatic oscillometric device for blood pressure measurement at home and consultations with the pharmacists plus usual care.
Pharmaceutical care	Pharmaceutical care	Consultations with the pharmacists plus usual care.
Home Blood Pressure Monitoring	HBPM	Automatic oscillometric device for blood pressure measurement at home plus usual care.

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