NCT00921791

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Apr 2006

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2009

Completed
Last Updated

June 16, 2009

Status Verified

June 1, 2009

Enrollment Period

2.8 years

First QC Date

June 15, 2009

Last Update Submit

June 15, 2009

Conditions

Hypertension

Keywords

HypertensionBlood pressureHome Blood Pressure MonitoringAmbulatory Blood Pressure MonitoringPharmaceutical care

Outcome Measures

Primary Outcomes (1)

  • Delta values for 24h ABPM between baseline and final ABPM measurements

    60 days

Secondary Outcomes (2)

  • Hypertension control

    60 days

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

    60 days

Study Arms (4)

Home Blood Pressure Monitoring

EXPERIMENTAL

Automatic oscillometric device for blood pressure measurement at home plus usual care.

Device: HBPM

HBPM and Pharmaceutical care

EXPERIMENTAL

Automatic oscillometric device for blood pressure measurement at home and consultations with the pharmacists plus usual care.

Device: HBPM and Pharmaceutical care

Pharmaceutical care

ACTIVE COMPARATOR

Consultations with the pharmacists plus usual care.

Behavioral: Pharmaceutical care

Control

ACTIVE COMPARATOR

Usual care: participants are instructed to keep on their current antihypertensive medication and receive non-pharmacological recommendations for hypertension treatment.

Other: Usual care

Interventions

HBPMDEVICE

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

Home Blood Pressure Monitoring
HBPM and Pharmaceutical careDEVICE

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

Also known as: HBPM
HBPM and Pharmaceutical care
Pharmaceutical careBEHAVIORAL

consultations with the pharmacists

Also known as: DADER method
Pharmaceutical care
Usual careOTHER

Consultation with the physician.

Also known as: Usual clinical practice.
Control

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Office BP ≥140/90 mm Hg
  • h ABPM hypertension BP ≥130/80 mm Hg
  • using at least one antihypertensive drug

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

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

Location

Related Publications (1)

  • 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.

    PMID: 22134392DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Pharmaceutical Services

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Health ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Sandra C. Fuchs, MD, PhD

    Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 15, 2009

First Posted

June 16, 2009

Study Start

April 1, 2006

Primary Completion

January 1, 2009

Study Completion

June 1, 2009

Last Updated

June 16, 2009

Record last verified: 2009-06

Locations

BR(1)