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Completed

NCT Number: NCT00921791

Efficacy of Home Blood Pressure Monitoring (MONITOR Study)

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).

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HBPM

Device

Automatic oscillometric device for home blood pressure measurement and usual care.

HBPM and Pharmaceutical care

Device

Automatic oscillometric device for blood pressure measurement at home and consultations with the pharmacists

Other names: HBPM

Pharmaceutical Care

Behavioral

consultations with the pharmacists

Other names: DADER method

Usual Care

Other

Consultation with the physician.

Other names: Usual clinical practice.

Primary outcomes

  1. Delta values for 24h ABPM between baseline and final ABPM measurements

    Time frame: 60 days

Secondary outcomes

  1. Hypertension control

    Time frame: 60 days

  2. Average of systolic and diastolic blood pressure at the end of the study.

    Time frame: 60 days

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Collaborators

  • 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

Registry information

Official study title

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

Acronym: MONITOR

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jun 16, 2009
Registry last updated
Jun 16, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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