Efficacy of Home Blood Pressure Monitoring (MONITOR Study)

NCT ID: NCT00921791

Last Updated: 2009-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2009-06-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Home Blood Pressure Monitoring

Automatic oscillometric device for blood pressure measurement at home plus usual care.

Group Type EXPERIMENTAL

HBPM

Intervention Type DEVICE

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

HBPM and Pharmaceutical care

Automatic oscillometric device for blood pressure measurement at home and consultations with the pharmacists plus usual care.

Group Type EXPERIMENTAL

HBPM and Pharmaceutical care

Intervention Type DEVICE

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

Pharmaceutical care

Consultations with the pharmacists plus usual care.

Group Type ACTIVE_COMPARATOR

Pharmaceutical care

Intervention Type BEHAVIORAL

consultations with the pharmacists

Control

Usual care: participants are instructed to keep on their current antihypertensive medication and receive non-pharmacological recommendations for hypertension treatment.

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type OTHER

Consultation with the physician.

Interventions

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HBPM

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

Intervention Type DEVICE

HBPM and Pharmaceutical care

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

Intervention Type DEVICE

Pharmaceutical care

consultations with the pharmacists

Intervention Type BEHAVIORAL

Usual care

Consultation with the physician.

Intervention Type OTHER

Other Intervention Names

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HBPM DADER method Usual clinical practice.

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil

OTHER

Sponsor Role collaborator

Federal University of Health Science of Porto Alegre

OTHER

Sponsor Role collaborator

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Hospital de Clínicas de Porto Alegre

Principal Investigators

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Sandra C. Fuchs, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio Grande do Sul

Locations

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Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 22134392 (View on PubMed)

Other Identifiers

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GPPG 04465

Identifier Type: -

Identifier Source: org_study_id

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