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

NCT ID: NCT01541566

Last Updated: 2016-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

254 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Arterial Hypertension Metabolic Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Conventional blood pressure measurement

Blood pressure measured only in the doctor's office during quarterly visits, without regular home blood pressure monitoring.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bracco Corporate

INDUSTRY

Sponsor Role collaborator

Istituto Auxologico Italiano

OTHER

Sponsor Role collaborator

Italian Institute of Telemedicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gianfranco Parati, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Auxologico Italiano

Locations

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Policlinico Universitario

Bari, Bari, Italy

Site Status

Spedali Civili

Brescia, Brescia, Italy

Site Status

Fondazione Maugeri

Lumezzane, Brescia, Italy

Site Status

Ospedale San Felice a Cancello

San Felice A Cancello, Caserta, Italy

Site Status

Istituto Auxologico Italiano

Milan, Milano, Italy

Site Status

Policlinico Universitario

Padua, Padova, Italy

Site Status

Ospedale di Broni

Broni, Pavia, Italy

Site Status

Fondazione Maugeri

Pavia, Pavia, Italy

Site Status

Ospedale Santa Chiara

Pisa, Pisa, Italy

Site Status

Ospedale Fatebenefratelli

Roma, Roma, Italy

Site Status

Casa di Cura Tortorella

Salerno, Salerno, Italy

Site Status

Ospedale di Circolo

Varese, Varese, Italy

Site Status

Countries

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Italy

References

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Brugnera A, Compare A, Omboni S, Greco A, Carrara S, Tasca GA, Poletti B, Parati G. Psychological covariates of blood pressure among patients with hypertension and metabolic syndrome. Health Psychol. 2022 Dec;41(12):946-954. doi: 10.1037/hea0001205. Epub 2022 Jul 21.

Reference Type DERIVED
PMID: 35862126 (View on PubMed)

Parati G, Omboni S, Compare A, Grossi E, Callus E, Venco A, Destro M, Villa G, Palatini P, Rosei EA, Scalvini S, Taddei S, Manfellotto D, Favale S, De Matteis C, Guglielmi M; TELEBPMET Study Group; Lonati L, Della Rosa F, Tosazzi E, Grandi AM, Maresca AM, Mongiardi C, Mare M, Ricci AR, Cagnoni F, Georgatos J, Besostri V, Ferrari V, Omodeo O, Dorigatti F, Bonso E, Guarnieri C, Muiesan L, Paini A, Stassaldi D, Cinelli A, Bernocchi P, Rocchi S, Magagna A, Ghiadoni L, Del Frate I, Boresi F, Guidi A, Re MA, Pellicciotti L, Florio A, Morani G, Di Lillo S, Ambrosio A, Casciello A, Quaglia M, Forleo C, Ardito MA, Gerunda S, Panunzio M. Blood pressure control and treatment adherence in hypertensive patients with metabolic syndrome: protocol of a randomized controlled study based on home blood pressure telemonitoring vs. conventional management and assessment of psychological determinants of adherence (TELEBPMET Study). Trials. 2013 Jan 23;14:22. doi: 10.1186/1745-6215-14-22.

Reference Type DERIVED
PMID: 23343138 (View on PubMed)

Other Identifiers

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TELEBPMET

Identifier Type: -

Identifier Source: org_study_id

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