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

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.
 
ClinicalTrials.gov Identifier: NCT00921791
Recruitment Status : Completed
First Posted : June 16, 2009
Last Update Posted : June 16, 2009
Sponsor:
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

Tracking Information
First Submitted Date  ICMJE June 15, 2009
First Posted Date  ICMJE June 16, 2009
Last Update Posted Date June 16, 2009
Study Start Date  ICMJE April 2006
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 15, 2009)
Delta values for 24h ABPM between baseline and final ABPM measurements [ Time Frame: 60 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 15, 2009)
  • Hypertension control [ Time Frame: 60 days ]
  • Average of systolic and diastolic blood pressure at the end of the study. [ Time Frame: 60 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Home Blood Pressure Monitoring (MONITOR Study)
Official Title  ICMJE Efficacy of Home Blood Pressure Monitoring to Improve Blood Pressure Control: a Randomized Controlled Trial With Ambulatory Blood Pressure Measurement
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Device: HBPM
    Automatic oscillometric device for home blood pressure measurement and usual care.
  • 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.
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 15, 2009)
136
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00921791
Other Study ID Numbers  ICMJE GPPG 04465
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sandra Costa Fuchs, MD, PhD, Hospital de Clínicas de Porto Alegre
Study Sponsor  ICMJE Hospital de Clinicas de Porto Alegre
Collaborators  ICMJE
  • 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  ICMJE
Principal Investigator: Sandra C. Fuchs, MD, PhD Federal University of Rio Grande do Sul
PRS Account Hospital de Clinicas de Porto Alegre
Verification Date June 2009

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