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
1 other identifier
observational
254
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2007
Typical duration for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 17, 2012
CompletedFirst Posted
Study publicly available on registry
March 1, 2012
CompletedFebruary 26, 2016
February 1, 2016
3.1 years
February 17, 2012
February 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (26)
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
- +21 more secondary outcomes
Study Arms (2)
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 Criteria
Patients referring to 12 Hypertension Centers (Hospitals) and suffering from arterial hypertension associated to metabolic syndrome
You may qualify if:
- 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)
You may not qualify if:
- Secondary arterial hypertension
- Severe liver or kidney disease
- Immunological disease
- Cardiac arrhythmias
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Italian Institute of Telemedicinelead
- Bracco Corporatecollaborator
- Istituto Auxologico Italianocollaborator
Study Sites (12)
Policlinico Universitario
Bari, Bari, 70124, Italy
Spedali Civili
Brescia, Brescia, 25123, Italy
Fondazione Maugeri
Lumezzane, Brescia, 25066, Italy
Ospedale San Felice a Cancello
San Felice A Cancello, Caserta, 81027, Italy
Istituto Auxologico Italiano
Milan, Milano, 20149, Italy
Policlinico Universitario
Padua, Padova, 35128, Italy
Ospedale di Broni
Broni, Pavia, 27043, Italy
Fondazione Maugeri
Pavia, Pavia, 27100, Italy
Ospedale Santa Chiara
Pisa, Pisa, 56100, Italy
Ospedale Fatebenefratelli
Roma, Roma, 00186, Italy
Casa di Cura Tortorella
Salerno, Salerno, 84122, Italy
Ospedale di Circolo
Varese, Varese, 21100, Italy
Related Publications (2)
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.
PMID: 35862126DERIVEDParati 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.
PMID: 23343138DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gianfranco Parati, MD
Istituto Auxologico Italiano
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2012
First Posted
March 1, 2012
Study Start
November 1, 2007
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
February 26, 2016
Record last verified: 2016-02