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 (TELEBPMET)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Italian Institute of Telemedicine.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Bracco
Istituto Auxologico Italiano
Docleader
Information provided by (Responsible Party):
Italian Institute of Telemedicine
ClinicalTrials.gov Identifier:
NCT01541566
First received: February 17, 2012
Last updated: April 17, 2012
Last verified: April 2012
  Purpose

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
Arterial Hypertension
Metabolic Syndrome

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Italian Institute of Telemedicine:

Primary Outcome Measures:
  • Percentage of subjects with average day-time ambulatory blood pressure <135/85 mmHg [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Percentage of subjects with average day-time ambulatory blood pressure <135/85 mmHg [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Psychological determinats of therapeutic adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Percentage of subjects with office blood pressure <140/90 mmHg [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Changes in home blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of additional medical visits [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Direct costs of intervention [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Number of antihypertensive drugs [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Level of cardiovascular risk by ESC Heart Score and Framingham [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Target organ damage and outcomes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Percentage of patients with metabolic syndrome [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Psychological determinats of therapeutic adherence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Percentage of subjects with office blood pressure <140/90 mmHg [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Changes in home blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of additional medical visits [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Direct costs of intervention [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Number of antihypertensive drugs [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Level of cardiovascular risk by ESC Heart Score and Framingham [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Target organ damage and outcomes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Percentage of patients with metabolic syndrome [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Percentage of subjects with home blood pressure <135/85 mmHg [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Percentage of subjects with home blood pressure <135/85 mmHg [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Changes in 24h blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Changes in 24h blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Changes in office blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Changes in office blood pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Adherence to treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Adherence to treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 254
Study Start Date: November 2007
Estimated Study Completion Date: June 2012
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients referring to 12 Hypertension Centers (Hospitals) and suffering from arterial hypertension associated to metabolic syndrome

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01541566

Locations
Italy
Fondazione Maugeri
Lumezzane, Brescia, Italy, 25066
Ospedale San Felice a Cancello
San Felice a Cancello, Caserta, Italy, 81027
Ospedale di Broni
Broni, Pavia, Italy, 27043
Policlinico Universitario
Bari, Italy, 70124
Spedali Civili
Brescia, Italy, 25123
Istituto Auxologico Italiano
Milano, Italy, 20149
Policlinico Universitario
Padova, Italy, 35128
Fondazione Maugeri
Pavia, Italy, 27100
Ospedale Santa Chiara
Pisa, Italy, 56100
Ospedale Fatebenefratelli
Roma, Italy, 00186
Casa di Cura Tortorella
Salerno, Italy, 84122
Ospedale di Circolo
Varese, Italy, 21100
Sponsors and Collaborators
Italian Institute of Telemedicine
Bracco
Istituto Auxologico Italiano
Docleader
Investigators
Principal Investigator: Gianfranco Parati, MD Istituto Auxologico Italiano
  More Information

No publications provided by Italian Institute of Telemedicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Italian Institute of Telemedicine
ClinicalTrials.gov Identifier: NCT01541566     History of Changes
Other Study ID Numbers: TELEBPMET
Study First Received: February 17, 2012
Last Updated: April 17, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by Italian Institute of Telemedicine:
arterial hypertension
metabolic syndrome
home blood pressure
ambulatory blood pressure
office blood pressure
telemedicine

Additional relevant MeSH terms:
Hypertension
Metabolic Syndrome X
Vascular Diseases
Cardiovascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 17, 2014