Efficacy of Home Blood Pressure Monitoring (MONITOR Study)

Hypertension Clinical Trial

— MONITOR  

Official title:

Efficacy of Home Blood Pressure Monitoring to Improve Blood Pressure Control: a Randomized Controlled Trial With Ambulatory Blood Pressure Measurement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00921791
• Other study ID #: GPPG 04465
• Status: Completed
• Phase: N/A
• First received: June 15, 2009
• Last updated: June 15, 2009
• Start date: April 2006
• Est. completion date: June 2009

Study information

• Verified date: June 2009
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: June 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Device:
• 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

Behavioral:
• Pharmaceutical care
consultations with the pharmacists

Other:
• Usual care
Consultation with the physician.

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	RS

Sponsors (4)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Federal University of Health Science of Porto Alegre, Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delta values for 24h ABPM between baseline and final ABPM measurements		60 days	No
Secondary	Hypertension control		60 days	No
Secondary	Average of systolic and diastolic blood pressure at the end of the study.		60 days	No