Efficacy of Home Blood Pressure Monitoring (MONITOR Study)

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

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

Conditions
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Hypertension

Intervention / Treatment
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* Device: HBPM
* Device: HBPM and Pharmaceutical care
* Behavioral: Pharmaceutical care
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home Blood Pressure Monitoring<br>Automatic oscillometric device for blood pressure measurement at home plus usual care. | Device: HBPM<br>* Automatic oscillometric device for home blood pressure measurement and usual care.<br>|
| Experimental: HBPM and Pharmaceutical care<br>Automatic oscillometric device for blood pressure measurement at home and consultations with the pharmacists plus usual care. | Device: HBPM and Pharmaceutical care<br>* Automatic oscillometric device for blood pressure measurement at home and consultations with the pharmacists<br>* Other names: HBPM;|
| Active Comparator: Pharmaceutical care<br>Consultations with the pharmacists plus usual care. | Behavioral: Pharmaceutical care<br>* consultations with the pharmacists<br>* Other names: DADER method;|
| Active Comparator: Control<br>Usual care: participants are instructed to keep on their current antihypertensive medication and receive non-pharmacological recommendations for hypertension treatment. | Other: Usual care<br>* Consultation with the physician.<br>* Other names: Usual clinical practice.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delta values for 24h ABPM between baseline and final ABPM measurements |  | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypertension control |  | 60 days | 
| Average of systolic and diastolic blood pressure at the end of the study. |  | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Blood pressure, Home Blood Pressure Monitoring, Ambulatory Blood Pressure Monitoring, Pharmaceutical care