Efficacy of Home Blood Pressure Monitoring (MONITOR Study)
NCT ID: NCT00921791
Last Updated: 2009-06-16
Study Results
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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COMPLETED
NA
136 participants
INTERVENTIONAL
2006-04-30
2009-06-30
Brief Summary
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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).
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Detailed Description
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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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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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Home Blood Pressure Monitoring
Automatic oscillometric device for blood pressure measurement at home plus usual care.
HBPM
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.
HBPM and Pharmaceutical care
Automatic oscillometric device for blood pressure measurement at home and consultations with the pharmacists
Pharmaceutical care
Consultations with the pharmacists plus usual care.
Pharmaceutical care
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.
Usual care
Consultation with the physician.
Interventions
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HBPM
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
Pharmaceutical care
consultations with the pharmacists
Usual care
Consultation with the physician.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 24h ABPM hypertension BP ≥130/80 mm Hg
* using at least one antihypertensive drug
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Conselho Nacional de Desenvolvimento Científico 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
OTHER
Hospital de Clinicas de Porto Alegre
OTHER
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
Countries
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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.
Other Identifiers
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GPPG 04465
Identifier Type: -
Identifier Source: org_study_id
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