Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2026-03-20 @ 8:55 PM
Study NCT ID:
NCT01541566
Status:
COMPLETED
Last Update Posted:
2016-02-26
First Post:
2012-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 254}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-25', 'studyFirstSubmitDate': '2012-02-17', 'studyFirstSubmitQcDate': '2012-02-29', 'lastUpdatePostDateStruct': {'date': '2016-02-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of subjects with average day-time ambulatory blood pressure <135/85 mmHg', 'timeFrame': '6 months'}, {'measure': 'Percentage of subjects with average day-time ambulatory blood pressure <135/85 mmHg', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Psychological determinats of therapeutic adherence', 'timeFrame': '6 months'}, {'measure': 'Percentage of subjects with office blood pressure <140/90 mmHg', 'timeFrame': '6 months'}, {'measure': 'Changes in home blood pressure', 'timeFrame': '6 months'}, {'measure': 'Number of additional medical visits', 'timeFrame': '6 months'}, {'measure': 'Direct costs of intervention', 'timeFrame': '6 months'}, {'measure': 'Number of antihypertensive drugs', 'timeFrame': '6 months'}, {'measure': 'Level of cardiovascular risk by ESC Heart Score and Framingham', 'timeFrame': '6 months'}, {'measure': 'Target organ damage and outcomes', 'timeFrame': '6 months'}, {'measure': 'Percentage of patients with metabolic syndrome', 'timeFrame': '6 months'}, {'measure': 'Psychological determinats of therapeutic adherence', 'timeFrame': '12 months'}, {'measure': 'Percentage of subjects with office blood pressure <140/90 mmHg', 'timeFrame': '12 months'}, {'measure': 'Changes in home blood pressure', 'timeFrame': '12 months'}, {'measure': 'Number of additional medical visits', 'timeFrame': '12 months'}, {'measure': 'Direct costs of intervention', 'timeFrame': '12 months'}, {'measure': 'Number of antihypertensive drugs', 'timeFrame': '12 months'}, {'measure': 'Level of cardiovascular risk by ESC Heart Score and Framingham', 'timeFrame': '12 months'}, {'measure': 'Target organ damage and outcomes', 'timeFrame': '12 months'}, {'measure': 'Percentage of patients with metabolic syndrome', 'timeFrame': '12 months'}, {'measure': 'Percentage of subjects with home blood pressure <135/85 mmHg', 'timeFrame': '6 months'}, {'measure': 'Percentage of subjects with home blood pressure <135/85 mmHg', 'timeFrame': '12 months'}, {'measure': 'Changes in 24h blood pressure', 'timeFrame': '6 months'}, {'measure': 'Changes in 24h blood pressure', 'timeFrame': '12 months'}, {'measure': 'Changes in office blood pressure', 'timeFrame': '6 months'}, {'measure': 'Changes in office blood pressure', 'timeFrame': '12 months'}, {'measure': 'Adherence to treatment', 'timeFrame': '6 months'}, {'measure': 'Adherence to treatment', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['arterial hypertension', 'metabolic syndrome', 'home blood pressure', 'ambulatory blood pressure', 'office blood pressure', 'telemedicine'], 'conditions': ['Arterial Hypertension', 'Metabolic Syndrome']}, 'referencesModule': {'references': [{'pmid': '35862126', 'type': 'DERIVED', 'citation': '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': '23343138', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients referring to 12 Hypertension Centers (Hospitals) and suffering from arterial hypertension associated to metabolic syndrome', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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)\n* Metabolic syndrome (ATP III criteria)\n\nExclusion Criteria:\n\n* Secondary arterial hypertension\n* Severe liver or kidney disease\n* Immunological disease\n* Cardiac arrhythmias'}, 'identificationModule': {'nctId': 'NCT01541566', 'acronym': 'TELEBPMET', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'Italian Institute of Telemedicine'}, 'officialTitle': 'Blood Pressure Control and Compliance to Treatment in Hypertensive Patients With Metabolic Syndrome: a Study Based on Home Blood Pressure Telemonitoring', 'orgStudyIdInfo': {'id': 'TELEBPMET'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Home blood pressure telemonitoring', 'description': '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.'}, {'label': 'Conventional blood pressure measurement', 'description': "Blood pressure measured only in the doctor's office during quarterly visits, without regular home blood pressure monitoring."}]}, 'contactsLocationsModule': {'locations': [{'zip': '70124', 'city': 'Bari', 'state': 'Bari', 'country': 'Italy', 'facility': 'Policlinico Universitario', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '25123', 'city': 'Brescia', 'state': 'Brescia', 'country': 'Italy', 'facility': 'Spedali Civili', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '25066', 'city': 'Lumezzane', 'state': 'Brescia', 'country': 'Italy', 'facility': 'Fondazione Maugeri', 'geoPoint': {'lat': 45.64789, 'lon': 10.26487}}, {'zip': '81027', 'city': 'San Felice A Cancello', 'state': 'Caserta', 'country': 'Italy', 'facility': 'Ospedale San Felice a Cancello', 'geoPoint': {'lat': 41.01702, 'lon': 14.48736}}, {'zip': '20149', 'city': 'Milan', 'state': 'Milano', 'country': 'Italy', 'facility': 'Istituto Auxologico Italiano', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '35128', 'city': 'Padua', 'state': 'Padova', 'country': 'Italy', 'facility': 'Policlinico Universitario', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '27043', 'city': 'Broni', 'state': 'Pavia', 'country': 'Italy', 'facility': 'Ospedale di Broni', 'geoPoint': {'lat': 45.06394, 'lon': 9.25993}}, {'zip': '27100', 'city': 'Pavia', 'state': 'Pavia', 'country': 'Italy', 'facility': 'Fondazione Maugeri', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'zip': '56100', 'city': 'Pisa', 'state': 'Pisa', 'country': 'Italy', 'facility': 'Ospedale Santa Chiara', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'zip': '00186', 'city': 'Roma', 'state': 'Roma', 'country': 'Italy', 'facility': 'Ospedale Fatebenefratelli', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '84122', 'city': 'Salerno', 'state': 'Salerno', 'country': 'Italy', 'facility': 'Casa di Cura Tortorella', 'geoPoint': {'lat': 40.67545, 'lon': 14.79328}}, {'zip': '21100', 'city': 'Varese', 'state': 'Varese', 'country': 'Italy', 'facility': 'Ospedale di Circolo', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}], 'overallOfficials': [{'name': 'Gianfranco Parati, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istituto Auxologico Italiano'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Italian Institute of Telemedicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bracco Corporate', 'class': 'INDUSTRY'}, {'name': 'Istituto Auxologico Italiano', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}