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| Name | Class |
|---|---|
| Bracco Corporate | INDUSTRY |
| Istituto Auxologico Italiano | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Psychological determinats of therapeutic adherence | 6 months | |
| Percentage of subjects with office blood pressure <140/90 mmHg | 6 months | |
| Changes in home blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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Patients referring to 12 Hypertension Centers (Hospitals) and suffering from arterial hypertension associated to metabolic syndrome
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| Name | Affiliation | Role |
|---|---|---|
| Gianfranco Parati, MD | Istituto Auxologico Italiano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico Universitario | Bari | Bari | 70124 | Italy | ||
| Spedali Civili |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35862126 | Derived | 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. | |
| 23343138 | Derived | 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. |
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| 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 |
| 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 | Padova | 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 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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