Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2026-02-24 @ 8:27 AM
Study NCT ID:
NCT01696318
Status:
COMPLETED
Last Update Posted:
2016-01-15
First Post:
2012-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Program for Cardiovascular Prevention and 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010166', 'term': 'Palliative Care'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 256}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-14', 'studyFirstSubmitDate': '2012-09-22', 'studyFirstSubmitQcDate': '2012-09-28', 'lastUpdatePostDateStruct': {'date': '2016-01-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Pressure', 'timeFrame': 'Change from baseline in Systolic Blood Pressure at 6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '27581760', 'type': 'DERIVED', 'citation': 'Kuhmmer R, Lazzaretti RK, Guterres CM, Raimundo FV, Leite LE, Delabary TS, Caon S, Bastos GA, Polanczyk CA. Effectiveness of multidisciplinary intervention on blood pressure control in primary health care: a randomized clinical trial. BMC Health Serv Res. 2016 Aug 31;16(1):456. doi: 10.1186/s12913-016-1703-0.'}]}, 'descriptionModule': {'briefSummary': 'Develop and evaluate a model of organization and management in the management of patients with cardiovascular risk factors (hypertension, diabetes mellitus, smoking, obesity, physical inactivity, dyslipidemia and family history) in primary care aimed at the compliance, control and treatment effectiveness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of hypertension (\\> 140/90 mmHg)\n* Age \\> 40 years\n* Sitting: USF da Restinga e Extremo Sul - USF Chapéu do Sol and USF Paulo Viaro\n\nExclusion Criteria:\n\n* Institutionalized individuals\n* Patients with mental illness or disabling chronic illnesses\n* Users of health services belonging to the supplementary health\n* Individuals with life expectancy less than 1 year'}, 'identificationModule': {'nctId': 'NCT01696318', 'briefTitle': 'Program for Cardiovascular Prevention and Randomized Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Rio Grande do Sul'}, 'officialTitle': 'Management Models for Cardiovascular Risk Reduction in Primary for Brazil: Developing a Program for Cardiovascular Prevention and Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'U1111-1134-6977'}, 'secondaryIdInfos': [{'id': 'HMV - 680', 'type': 'OTHER', 'domain': 'Comite de Ética em Pesquisa Hospital Moinhos de Vento'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Educational program', 'description': 'Educational Program with Professional Physical Education, Pharmacist and Nutritionist'}, {'type': 'EXPERIMENTAL', 'label': 'Educational program and individual care', 'description': 'Educational program and individual care with professional Physical Education; Pharmacist and Nutritionist', 'interventionNames': ['Behavioral: Support for the Family Health Team']}], 'interventions': [{'name': 'Support for the Family Health Team', 'type': 'BEHAVIORAL', 'description': 'Participation in physical educator, dietitian and pharmacist in primary health care', 'armGroupLabels': ['Educational program and individual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90035-001', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital Moinhos de Vento', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'overallOfficials': [{'name': 'Carisi Polanczyc, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'UFRGS/HMV'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Rio Grande do Sul', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Moinhos de Vento', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Fabiana Viegas Raimundo', 'investigatorAffiliation': 'Federal University of Rio Grande do Sul'}}}}