Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2026-02-24 @ 5:45 AM
Study NCT ID:
NCT02230293
Status:
COMPLETED
Last Update Posted:
2014-09-03
First Post:
2014-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assistance Multidisciplinary in Hypertensive Patient: Randomized Clinical Trial
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': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-02', 'studyFirstSubmitDate': '2014-08-06', 'studyFirstSubmitQcDate': '2014-09-02', 'lastUpdatePostDateStruct': {'date': '2014-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Systolic and Diastolic Blood pressure', 'timeFrame': 'Measured at the first appointment and 1 year later'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ambulatory care,', 'hypertension,', 'health personnel,', 'clinical trial'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if multidisciplinary care improves the health condition of hypertensives.', 'detailedDescription': 'A multidisciplinary approach in managing hypertensive patients has shown benefits in reducing blood pressure and risk factors for hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '67 Years', 'minimumAge': '41 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Above 18 years of age\n* Diagnosis of hypertension\n\nExclusion Criteria:\n\n* Secondary hypertension\n* Hypertensive patients with congenital cardiopathy\n* Surgical patients\n* Proven myocardial infarction'}, 'identificationModule': {'nctId': 'NCT02230293', 'acronym': 'MULTIHAS', 'briefTitle': 'Assistance Multidisciplinary in Hypertensive Patient: Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Instituto de Cardiologia do Rio Grande do Sul'}, 'officialTitle': 'Assistance Multidisciplinary in Hypertensive Patient: Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'UP 3927-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Group', 'description': 'Conventional treatment and follow up', 'interventionNames': ['Other: Conventional treatment and follow up']}, {'type': 'EXPERIMENTAL', 'label': 'Multidisciplinary Group', 'description': 'Multidisciplinary assistance', 'interventionNames': ['Other: Multidisciplinary assistance']}], 'interventions': [{'name': 'Multidisciplinary assistance', 'type': 'OTHER', 'description': 'Multidisciplinary group assistance was effected every two months by all professionals (physician, nurse, dietitian, physiotherapist and psychologist) and consisted in orientations and mechanisms to medication and non-pharmacological adherence (lifestyle changes).', 'armGroupLabels': ['Multidisciplinary Group']}, {'name': 'Conventional treatment and follow up', 'type': 'OTHER', 'description': 'Assistance was effected by physician and nurse and consisted about adapting to the drug', 'armGroupLabels': ['Conventional Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90620-000', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Instituto de Cardiologia do Rio Grande do Sul', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'overallOfficials': [{'name': 'Silvia Goldmeier, Dr', 'role': 'STUDY_CHAIR', 'affiliation': 'Instituto de Cardiologia do Rio Grande do Sul'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto de Cardiologia do Rio Grande do Sul', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Silvia Goldmeier', 'investigatorAffiliation': 'Instituto de Cardiologia do Rio Grande do Sul'}}}}