Blood Pressure Control and Compliance to Treatment in Hypertensive Patients With Metabolic Syndrome: a Study Based on Home Blood Pressure Telemonitoring and Assessment of Psychological Determinants

Completed

• Conditions: Arterial Hypertension; Metabolic Syndrome

• Registration Number: NCT01541566
• Lead Sponsor: Italian Institute of Telemedicine

Brief Summary

The purpose of this study is to assess whether, in patients at high cardiovascular risk (hypertension with metabolic syndrome), long-term (1-year) blood pressure control is most effective when based on home blood pressure telemonitoring and on the feedback to the patient by the doctor between visits, or when based only on blood pressure determination during quarterly office visits.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2012-02-17
• Study First Submitted QC: 2012-02-29
• Study First Posted: 2012-03-01
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-25
• Last Update Posted: 2016-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 254

Inclusion Criteria

• Treated or untreated uncontrolled essential arterial hypertension (office systolic blood pressure >140 or diastolic >90 mmHg + day-time systolic blood pressure >135 or day-time diastolic blood pressure >85 mmHg)
• Metabolic syndrome (ATP III criteria)

Exclusion Criteria

• Secondary arterial hypertension
• Severe liver or kidney disease
• Immunological disease
• Cardiac arrhythmias

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of subjects with average day-time ambulatory blood pressure <135/85 mmHg	12 months

Secondary Outcome Measures

Name	Time	Method
Percentage of subjects with office blood pressure <140/90 mmHg	12 months
Number of antihypertensive drugs	12 months
Number of additional medical visits	12 months
Level of cardiovascular risk by ESC Heart Score and Framingham	12 months
Target organ damage and outcomes	12 months
Changes in home blood pressure	12 months
Percentage of patients with metabolic syndrome	12 months
Psychological determinats of therapeutic adherence	12 months
Direct costs of intervention	12 months
Percentage of subjects with home blood pressure <135/85 mmHg	12 months
Changes in 24h blood pressure	12 months
Changes in office blood pressure	12 months
Adherence to treatment	12 months

Trial Locations

Locations (10)

Ospedale San Felice a Cancello; 🇮🇹 San Felice a Cancello, Caserta, Italy

Ospedale di Broni; 🇮🇹 Broni, Pavia, Italy

Policlinico Universitario; 🇮🇹 Padova, Italy

Spedali Civili; 🇮🇹 Brescia, Italy

Istituto Auxologico Italiano; 🇮🇹 Milano, Italy

Ospedale Santa Chiara; 🇮🇹 Pisa, Italy

Ospedale Fatebenefratelli; 🇮🇹 Roma, Italy

Casa di Cura Tortorella; 🇮🇹 Salerno, Italy

Ospedale di Circolo; 🇮🇹 Varese, Italy

Fondazione Maugeri; 🇮🇹 Pavia, Italy