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)

February 25, 2016 updated by: Italian Institute of Telemedicine

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
254

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bari, Italy, 70124
        • Policlinico Universitario
      • Brescia, Italy, 25123
        • Spedali Civili
      • Milano, Italy, 20149
        • Istituto Auxologico Italiano
      • Padova, Italy, 35128
        • Policlinico Universitario
      • Pavia, Italy, 27100
        • Fondazione Maugeri
      • Pisa, Italy, 56100
        • Ospedale Santa Chiara
      • Roma, Italy, 00186
        • Ospedale Fatebenefratelli
      • Salerno, Italy, 84122
        • Casa di Cura Tortorella
      • Varese, Italy, 21100
        • Ospedale di Circolo
    • Brescia
      • Lumezzane, Brescia, Italy, 25066
        • Fondazione Maugeri
    • Caserta
      • San Felice a Cancello, Caserta, Italy, 81027
        • Ospedale San Felice a Cancello
    • Pavia
      • Broni, Pavia, Italy, 27043
        • Ospedale di Broni

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of subjects with average day-time ambulatory blood pressure <135/85 mmHg
Time Frame: 6 months
6 months
Percentage of subjects with average day-time ambulatory blood pressure <135/85 mmHg
Time Frame: 12 months
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Psychological determinats of therapeutic adherence
Time Frame: 6 months
6 months
Percentage of subjects with office blood pressure <140/90 mmHg
Time Frame: 6 months
6 months
Changes in home blood pressure
Time Frame: 6 months
6 months
Number of additional medical visits
Time Frame: 6 months
6 months
Direct costs of intervention
Time Frame: 6 months
6 months
Number of antihypertensive drugs
Time Frame: 6 months
6 months
Level of cardiovascular risk by ESC Heart Score and Framingham
Time Frame: 6 months
6 months
Target organ damage and outcomes
Time Frame: 6 months
6 months
Percentage of patients with metabolic syndrome
Time Frame: 6 months
6 months
Psychological determinats of therapeutic adherence
Time Frame: 12 months
12 months
Percentage of subjects with office blood pressure <140/90 mmHg
Time Frame: 12 months
12 months
Changes in home blood pressure
Time Frame: 12 months
12 months
Number of additional medical visits
Time Frame: 12 months
12 months
Direct costs of intervention
Time Frame: 12 months
12 months
Number of antihypertensive drugs
Time Frame: 12 months
12 months
Level of cardiovascular risk by ESC Heart Score and Framingham
Time Frame: 12 months
12 months
Target organ damage and outcomes
Time Frame: 12 months
12 months
Percentage of patients with metabolic syndrome
Time Frame: 12 months
12 months
Percentage of subjects with home blood pressure <135/85 mmHg
Time Frame: 6 months
6 months
Percentage of subjects with home blood pressure <135/85 mmHg
Time Frame: 12 months
12 months
Changes in 24h blood pressure
Time Frame: 6 months
6 months
Changes in 24h blood pressure
Time Frame: 12 months
12 months
Changes in office blood pressure
Time Frame: 6 months
6 months
Changes in office blood pressure
Time Frame: 12 months
12 months
Adherence to treatment
Time Frame: 6 months
6 months
Adherence to treatment
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Italian Institute of Telemedicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Istituto Auxologico Italiano
Bracco Corporate

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gianfranco Parati, MD, Istituto Auxologico Italiano

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 17, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 29, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 1, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 26, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TELEBPMET

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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