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

Metabolic Syndrome Clinical Trial

— TELEBPMET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01541566
• Other study ID #: TELEBPMET
• Status: Completed
• Phase: N/A
• First received: February 17, 2012
• Last updated: February 25, 2016
• Start date: November 2007
• Est. completion date: December 2010

Study information

• Verified date: February 2016
• Source: Italian Institute of Telemedicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 74 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arterial Hypertension
• Hypertension
• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Locations

Country	Name	City	State
Italy	Policlinico Universitario	Bari
Italy	Spedali Civili	Brescia
Italy	Ospedale di Broni	Broni	Pavia
Italy	Fondazione Maugeri	Lumezzane	Brescia
Italy	Istituto Auxologico Italiano	Milano
Italy	Policlinico Universitario	Padova
Italy	Fondazione Maugeri	Pavia
Italy	Ospedale Santa Chiara	Pisa
Italy	Ospedale Fatebenefratelli	Roma
Italy	Casa di Cura Tortorella	Salerno
Italy	Ospedale San Felice a Cancello	San Felice a Cancello	Caserta
Italy	Ospedale di Circolo	Varese

Sponsors (3)

Lead Sponsor	Collaborator
Italian Institute of Telemedicine	Bracco Corporate, Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects with average day-time ambulatory blood pressure <135/85 mmHg		6 months	No
Primary	Percentage of subjects with average day-time ambulatory blood pressure <135/85 mmHg		12 months	No
Secondary	Psychological determinats of therapeutic adherence		6 months	No
Secondary	Percentage of subjects with office blood pressure <140/90 mmHg		6 months	No
Secondary	Changes in home blood pressure		6 months	No
Secondary	Number of additional medical visits		6 months	No
Secondary	Direct costs of intervention		6 months	No
Secondary	Number of antihypertensive drugs		6 months	No
Secondary	Level of cardiovascular risk by ESC Heart Score and Framingham		6 months	No
Secondary	Target organ damage and outcomes		6 months	No
Secondary	Percentage of patients with metabolic syndrome		6 months	No
Secondary	Psychological determinats of therapeutic adherence		12 months	No
Secondary	Percentage of subjects with office blood pressure <140/90 mmHg		12 months	No
Secondary	Changes in home blood pressure		12 months	No
Secondary	Number of additional medical visits		12 months	No
Secondary	Direct costs of intervention		12 months	No
Secondary	Number of antihypertensive drugs		12 months	No
Secondary	Level of cardiovascular risk by ESC Heart Score and Framingham		12 months	No
Secondary	Target organ damage and outcomes		12 months	No
Secondary	Percentage of patients with metabolic syndrome		12 months	No
Secondary	Percentage of subjects with home blood pressure <135/85 mmHg		6 months	No
Secondary	Percentage of subjects with home blood pressure <135/85 mmHg		12 months	No
Secondary	Changes in 24h blood pressure		6 months	No
Secondary	Changes in 24h blood pressure		12 months	No
Secondary	Changes in office blood pressure		6 months	No
Secondary	Changes in office blood pressure		12 months	No
Secondary	Adherence to treatment		6 months	No
Secondary	Adherence to treatment		12 months	No