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Efficacy of Home Blood Pressure Monitoring (MONITOR Study)

This study has been completed.
Sponsor:
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
UFRGS
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT00921791
First received: June 15, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted

June 15, 2009
June 15, 2009
April 2006
January 2009   (final data collection date for primary outcome measure)
Delta values for 24h ABPM between baseline and final ABPM measurements [ Time Frame: 60 days ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Hypertension control [ Time Frame: 60 days ] [ Designated as safety issue: No ]
  • Average of systolic and diastolic blood pressure at the end of the study. [ Time Frame: 60 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy of Home Blood Pressure Monitoring (MONITOR Study)
Efficacy of Home Blood Pressure Monitoring to Improve Blood Pressure Control: a Randomized Controlled Trial With Ambulatory Blood Pressure Measurement

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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Hypertension
  • Device: HBPM
    Automatic oscillometric device for home blood pressure measurement and usual care.
    Other Name: HBPM
  • Device: HBPM and Pharmaceutical care
    Automatic oscillometric device for blood pressure measurement at home and consultations with the pharmacists
    Other Name: HBPM
  • Behavioral: Pharmaceutical care
    consultations with the pharmacists
    Other Name: DADER method
  • Other: Usual care
    Consultation with the physician.
    Other Name: Usual clinical practice.
  • Experimental: Home Blood Pressure Monitoring
    Automatic oscillometric device for blood pressure measurement at home plus usual care.
    Intervention: Device: HBPM
  • Experimental: HBPM and Pharmaceutical care
    Automatic oscillometric device for blood pressure measurement at home and consultations with the pharmacists plus usual care.
    Intervention: Device: HBPM and Pharmaceutical care
  • Active Comparator: Pharmaceutical care
    Consultations with the pharmacists plus usual care.
    Intervention: Behavioral: Pharmaceutical care
  • Active Comparator: Control
    Usual care: participants are instructed to keep on their current antihypertensive medication and receive non-pharmacological recommendations for hypertension treatment.
    Intervention: Other: Usual care
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
136
June 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00921791
GPPG 04465
No
Sandra Costa Fuchs, MD, PhD, Hospital de Clínicas de Porto Alegre
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
  • UFRGS
Principal Investigator: Sandra C. Fuchs, MD, PhD Federal University of Rio Grande do Sul
Hospital de Clinicas de Porto Alegre
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP