Efficacy of Home Blood Pressure Monitoring (MONITOR Study) (MONITOR)
|ClinicalTrials.gov Identifier: NCT00921791|
Recruitment Status : Completed
First Posted : June 16, 2009
Last Update Posted : June 16, 2009
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).
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Device: HBPM Device: HBPM and Pharmaceutical care Behavioral: Pharmaceutical care Other: Usual care||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||136 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Efficacy of Home Blood Pressure Monitoring to Improve Blood Pressure Control: a Randomized Controlled Trial With Ambulatory Blood Pressure Measurement|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||June 2009|
Experimental: Home Blood Pressure Monitoring
Automatic oscillometric device for blood pressure measurement at home plus usual care.
Automatic oscillometric device for home blood pressure measurement and usual care.
Experimental: HBPM and Pharmaceutical care
Automatic oscillometric device for blood pressure measurement at home and consultations with the pharmacists plus usual care.
Device: HBPM and Pharmaceutical care
Automatic oscillometric device for blood pressure measurement at home and consultations with the pharmacists
Other Name: HBPM
Active Comparator: Pharmaceutical care
Consultations with the pharmacists plus usual care.
Behavioral: Pharmaceutical care
consultations with the pharmacists
Other Name: DADER method
Active Comparator: Control
Usual care: participants are instructed to keep on their current antihypertensive medication and receive non-pharmacological recommendations for hypertension treatment.
Other: Usual care
Consultation with the physician.
Other Name: Usual clinical practice.
- Delta values for 24h ABPM between baseline and final ABPM measurements [ Time Frame: 60 days ]
- Hypertension control [ Time Frame: 60 days ]
- Average of systolic and diastolic blood pressure at the end of the study. [ Time Frame: 60 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00921791
|Hospital de Clínicas de Porto Alegre|
|Porto Alegre, RS, Brazil, 90035-903|
|Principal Investigator:||Sandra C. Fuchs, MD, PhD||Federal University of Rio Grande do Sul|