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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01541566

Acronym

TELEBPMET

Enrollment

254

Registered

2012-03-01

Start date

2007-11-30

Completion date

2010-12-31

Last updated

2016-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial Hypertension, Metabolic Syndrome

Keywords

arterial hypertension, metabolic syndrome, home blood pressure, ambulatory blood pressure, office blood pressure, 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 74 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Percentage of subjects with average day-time ambulatory blood pressure <135/85 mmHg	6 months

Secondary

Measure	Time frame
Psychological determinats of therapeutic adherence	6 months
Percentage of subjects with office blood pressure <140/90 mmHg	6 months
Changes in home blood pressure	6 months
Number of additional medical visits	6 months
Direct costs of intervention	6 months
Number of antihypertensive drugs	6 months
Adherence to treatment	6 months
Target organ damage and outcomes	6 months
Percentage of patients with metabolic syndrome	6 months
Percentage of subjects with home blood pressure <135/85 mmHg	6 months
Changes in 24h blood pressure	6 months
Changes in office blood pressure	6 months
Level of cardiovascular risk by ESC Heart Score and Framingham	6 months

Countries

Italy

Outcome results