Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-02-22 @ 4:14 PM
Study NCT ID:
NCT02511093
Status:
UNKNOWN
Last Update Posted:
2015-07-29
First Post:
2015-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Team-Based Care for Hypertension Management (TBC-HTA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-07-28', 'studyFirstSubmitDate': '2015-07-27', 'studyFirstSubmitQcDate': '2015-07-28', 'lastUpdatePostDateStruct': {'date': '2015-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in daytime ABPM at 6-month between TBC and usual care patients', 'timeFrame': '6-month', 'description': 'Difference in daytime ABPM at 6-month between TBC and usual care patients'}, {'measure': 'Difference in the proportion of patients with controlled blood pressure (daytime ABPM <135/85 mmHg) at 6-month between TBC and usual care patients', 'timeFrame': '6-month', 'description': 'Difference in the proportion of patients with controlled blood pressure (daytime ABPM \\<135/85 mmHg) at 6-month between TBC and usual care patients'}], 'secondaryOutcomes': [{'measure': "Patients and healthcare professionals' acceptance and satisfaction with the TBC-intervention", 'timeFrame': '6-month', 'description': "Patients and healthcare professionals' acceptance and satisfaction with the TBC-intervention"}, {'measure': 'Difference in the proportion of TBC and usual care patients with controlled blood pressure (daytime ABPM <135/85 mmHg) at 12-month (6 months after intervention stopped)', 'timeFrame': '12-month', 'description': 'Difference in the proportion of TBC and usual care patients with controlled blood pressure (daytime ABPM \\<135/85 mmHg) at 12-month (6 months after intervention stopped)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Team-based care', 'Collaboration', 'Healthcare professionals', 'Healthcare services'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '34760950', 'type': 'DERIVED', 'citation': 'Santschi V, Wuerzner G, Pais B, Chiolero A, Schaller P, Cloutier L, Paradis G, Burnier M. Team-Based Care for Improving Hypertension Management: A Pragmatic Randomized Controlled Trial. Front Cardiovasc Med. 2021 Oct 25;8:760662. doi: 10.3389/fcvm.2021.760662. eCollection 2021.'}, {'pmid': '28109266', 'type': 'DERIVED', 'citation': 'Santschi V, Wuerzner G, Chiolero A, Burnand B, Schaller P, Cloutier L, Paradis G, Burnier M. Team-based care for improving hypertension management among outpatients (TBC-HTA): study protocol for a pragmatic randomized controlled trial. BMC Cardiovasc Disord. 2017 Jan 21;17(1):39. doi: 10.1186/s12872-017-0472-y.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether a team-based care (TBC) intervention, combining physician, nurse and pharmacist care improves BP control compared to usual care at 6 months among outpatients with uncontrolled hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* treated patients with uncontrolled hypertension (defined as daytime systolic/diastolic ambulatory blood pressure monitoring (ABPM) ≥135/85mmHg) taking one or two antihypertensive medications;\n* speak and understand French;\n* agree to use the same pharmacy's services for the whole duration of the study.\n\nExclusion Criteria:\n\n* unable to understand the study aim;\n* pregnancy and lactating;\n* livimg in a nursing home;\n* hospitalization during the recruitment period;\n* participation in another study;\n* daytime ABPM\\>180/110 mmHg."}, 'identificationModule': {'nctId': 'NCT02511093', 'acronym': 'TBC-HTA', 'briefTitle': 'A Team-Based Care for Hypertension Management (TBC-HTA)', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Vaudois'}, 'officialTitle': 'A Team-Based Care for Hypertension Management (TBC-HTA): A Randomized Controlled Study', 'orgStudyIdInfo': {'id': '449/13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TBC intervention', 'description': 'A structured collaborative intervention delivered by trained nurses of ambulatory clinics and by community pharmacists working in collaboration with physicians during 6-month of follow-up includes:\n\n* BP measurements;\n* an educational and counselling intervention on patient adherence;\n* an educational and counselling intervention on lifestyle (physical activity and diet).\n\nPhysicians adjust antihypertensive medications based on nurse and pharmacist feedback.', 'interventionNames': ['Behavioral: TBC intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care'}], 'interventions': [{'name': 'TBC intervention', 'type': 'BEHAVIORAL', 'description': 'A structured collaborative intervention delivered by trained nurses of ambulatory clinics and by community pharmacists working in collaboration with physicians during 6-month of follow-up includes:\n\n* BP measurements;\n* an educational and counselling intervention on patient adherence;\n* an educational and counselling intervention on lifestyle (physical activity and diet) Physicians adjust antihypertensive medications based on nurse and pharmacist feedback.', 'armGroupLabels': ['TBC intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1011', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Valerie Santschi, PhD', 'role': 'CONTACT', 'email': 'v.santschi@ecolelasource.ch', 'phone': '0041 21 641 38 24'}, {'name': 'Michel Burnier, MD', 'role': 'CONTACT', 'email': 'michel.burnier@chuv.ch', 'phone': '0041 21 314 11 29'}], 'facility': 'Service de Néphrologie et Hypertension, Centre Hospitalier Universitaire Vaudois', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'centralContacts': [{'name': 'Valerie Santschi, PhD', 'role': 'CONTACT', 'email': 'v.santschi@ecolelasource.ch', 'phone': '0041 21 641 38 24'}, {'name': 'Michel Burnier, MD', 'role': 'CONTACT', 'email': 'michel.burnier@chuv.ch', 'phone': '0041 21 314 11 29'}], 'overallOfficials': [{'name': 'Valerie Santschi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire Vaudois'}, {'name': 'Michel Burnier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire Vaudois'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Vaudois', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Applied Sciences of Western Switzerland', 'class': 'OTHER'}, {'name': 'Université du Québec à Trois-Rivières', 'class': 'OTHER'}, {'name': 'McGill University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Valérie Santschi, PharmDipl, PhD', 'investigatorFullName': 'Valérie Santschi', 'investigatorAffiliation': 'Centre Hospitalier Universitaire Vaudois'}}}}