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Efficacy of Home Blood Pressure Monitoring (MONITOR Study) (MONITOR)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00921791
First Posted: June 16, 2009
Last Update Posted: June 16, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
Federal University of Health Science of Porto Alegre
Information provided by:
Hospital de Clinicas de Porto Alegre
  Purpose

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).


Condition Intervention
Hypertension Device: HBPM Device: HBPM and Pharmaceutical care Behavioral: Pharmaceutical care Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Home Blood Pressure Monitoring to Improve Blood Pressure Control: a Randomized Controlled Trial With Ambulatory Blood Pressure Measurement

Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Delta values for 24h ABPM between baseline and final ABPM measurements [ Time Frame: 60 days ]

Secondary Outcome Measures:
  • Hypertension control [ Time Frame: 60 days ]
  • Average of systolic and diastolic blood pressure at the end of the study. [ Time Frame: 60 days ]

Enrollment: 136
Study Start Date: April 2006
Study Completion Date: June 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Home Blood Pressure Monitoring
Automatic oscillometric device for blood pressure measurement at home plus usual care.
Device: HBPM
Automatic oscillometric device for home blood pressure measurement and usual care.
Experimental: HBPM and Pharmaceutical care
Automatic oscillometric device for blood pressure measurement at home and consultations with the pharmacists plus usual care.
Device: HBPM and Pharmaceutical care
Automatic oscillometric device for blood pressure measurement at home and consultations with the pharmacists
Other Name: HBPM
Active Comparator: Pharmaceutical care
Consultations with the pharmacists plus usual care.
Behavioral: Pharmaceutical care
consultations with the pharmacists
Other Name: DADER method
Active Comparator: Control
Usual care: participants are instructed to keep on their current antihypertensive medication and receive non-pharmacological recommendations for hypertension treatment.
Other: Usual care
Consultation with the physician.
Other Name: Usual clinical practice.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00921791


Locations
Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, RS, Brazil, 90035-903
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
Federal University of Health Science of Porto Alegre
Investigators
Principal Investigator: Sandra C. Fuchs, MD, PhD Federal University of Rio Grande do Sul
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sandra Costa Fuchs, MD, PhD, Hospital de Clínicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT00921791     History of Changes
Other Study ID Numbers: GPPG 04465
First Submitted: June 15, 2009
First Posted: June 16, 2009
Last Update Posted: June 16, 2009
Last Verified: June 2009

Keywords provided by Hospital de Clinicas de Porto Alegre:
Hypertension
Blood pressure
Home Blood Pressure Monitoring
Ambulatory Blood Pressure Monitoring
Pharmaceutical care

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases