Efficacy of Home Blood Pressure Monitoring (MONITOR Study)

Hospital de Clinicas de Porto Alegre

Status: Completed

Conditions: Hypertension

Treatments: Device: HBPM; Behavioral: Pharmaceutical care; Device: HBPM and Pharmaceutical care; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT00921791

GPPG 04465

Details and patient eligibility

About

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).

Full 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.

Enrollment: 136 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

---

136 participants in 4 patient groups

Home Blood Pressure Monitoring

Experimental group

Description:

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

Treatment:

Device: HBPM

HBPM and Pharmaceutical care

Experimental group

Description:

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

Treatment:

Device: HBPM and Pharmaceutical care

Pharmaceutical care

Active Comparator group

Description:

Consultations with the pharmacists plus usual care.

Treatment:

Behavioral: Pharmaceutical care

Control

Active Comparator group

Description:

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

Treatment:

Other: Usual care