TELEBPMET: 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

Sponsor

Italian Institute of Telemedicine (Other)

Overall Status

Completed

CT.gov ID

NCT01541566

Collaborator

Bracco Corporate (Industry), Istituto Auxologico Italiano (Other)

254

Enrollment

Locations

Duration (Months)

21.2

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arterial Hypertension Metabolic Syndrome

Study Design

Study Type:

Observational

Actual Enrollment :

254 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Nov 1, 2007

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Home blood pressure telemonitoring Patients regularly monitoring their blood pressure at home with an electronic validated upper arm device, transmitting blood pressure values at monthly intervals to the doctors office through the Internet.
Conventional blood pressure measurement Blood pressure measured only in the doctor's office during quarterly visits, without regular home blood pressure monitoring.

Outcome Measures

Primary Outcome Measures

Percentage of subjects with average day-time ambulatory blood pressure <135/85 mmHg [6 months]
Percentage of subjects with average day-time ambulatory blood pressure <135/85 mmHg [12 months]

Secondary Outcome Measures

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]
Level of cardiovascular risk by ESC Heart Score and Framingham [6 months]
Target organ damage and outcomes [6 months]
Percentage of patients with metabolic syndrome [6 months]
Psychological determinats of therapeutic adherence [12 months]
Percentage of subjects with office blood pressure <140/90 mmHg [12 months]
Changes in home blood pressure [12 months]
Number of additional medical visits [12 months]
Direct costs of intervention [12 months]
Number of antihypertensive drugs [12 months]
Level of cardiovascular risk by ESC Heart Score and Framingham [12 months]
Target organ damage and outcomes [12 months]
Percentage of patients with metabolic syndrome [12 months]
Percentage of subjects with home blood pressure <135/85 mmHg [6 months]
Percentage of subjects with home blood pressure <135/85 mmHg [12 months]
Changes in 24h blood pressure [6 months]
Changes in 24h blood pressure [12 months]
Changes in office blood pressure [6 months]
Changes in office blood pressure [12 months]
Adherence to treatment [6 months]
Adherence to treatment [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 74 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondazione Maugeri	Lumezzane	Brescia	Italy	25066
2	Ospedale San Felice a Cancello	San Felice a Cancello	Caserta	Italy	81027
3	Ospedale di Broni	Broni	Pavia	Italy	27043
4	Policlinico Universitario	Bari		Italy	70124
5	Spedali Civili	Brescia		Italy	25123
6	Istituto Auxologico Italiano	Milano		Italy	20149
7	Policlinico Universitario	Padova		Italy	35128
8	Fondazione Maugeri	Pavia		Italy	27100
9	Ospedale Santa Chiara	Pisa		Italy	56100
10	Ospedale Fatebenefratelli	Roma		Italy	00186
11	Casa di Cura Tortorella	Salerno		Italy	84122
12	Ospedale di Circolo	Varese		Italy	21100