Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-31 @ 8:55 PM
Study NCT ID:
NCT01560806
Status:
COMPLETED
Last Update Posted:
2012-03-22
First Post:
2012-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intervention Study on Hypertension Management Combined With Health Promotion at Commune Level
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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-20', 'studyFirstSubmitDate': '2012-03-19', 'studyFirstSubmitQcDate': '2012-03-20', 'lastUpdatePostDateStruct': {'date': '2012-03-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of people with high blood pressure receiving treatment and being controlled in intervention commune', 'timeFrame': 'Baseline and after 3-year', 'description': 'Changes in proportion of treated and controlled hypertension after 3-years intervention compared to baseline'}], 'secondaryOutcomes': [{'measure': 'Changes in prevalences of behavioral cardiovascular risk factors in intervention commune', 'timeFrame': 'Baseline and after 3-year', 'description': 'Changes in prevalence of behavioral cardiovascular risk factors after 3-years intervention compared to baseline'}, {'measure': 'Changes in average blood pressure in the population in intervention commune', 'timeFrame': 'Baseline and after 3 years', 'description': 'Changes in average systolic and diastolic blood pressure in the studied population after 3-year intervention'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hypertension', 'cardiovascular risk factor', 'lifestyle'], 'conditions': ['Hypertension', 'Cardiovascular Risk Factor', 'Lifestyle']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.huyetap.vn', 'label': 'Information involved in the National Targeted Programme on Hypertension Prevention and Control'}]}, 'descriptionModule': {'briefSummary': 'A quasi-experimental study design was chosen to compare the model of hypertension management at commune-level with conventional management for people with high blood pressure in two communes (one for intervention versus one for reference).\n\nA intervention model included the commune-based programme on hypertension management combined with comprehensive health promotion campaigns', 'detailedDescription': 'A quasi-experimental study design was chosen: two communes were purposively selected from Ba-Vi setting: Phu-Phuong for reference and Phu-Cuong for intervention communes A hypertension management programme and the nested comprehensive health promotion campaigns were implemented simultaneously in Phu-Cuong while nothing performed in Phu-Phuong except for local conventional healthcare services.\n\nThe health promotion campaigns aimed at smoking cessation, reduction of alcohol consumption, encourage of unsalted diet and physical activity, all of which targeted to every local inhabitants.\n\nThe hypertension management programme focused on monthly check-ups, drug delivery and individual lifestyle consultation, all of which targeted to hypertensives only.\n\nBaseline cross-sectional survey was used to assess cardiovascular pattern in local community before intervention and recruit people with high blood pressure for the management programme in intervention commune Repeated cross-sectional surveys were used to evaluate the impacts of health promotion.\n\nCohort study on hypertensives was used to evaluate the impacts of the management programme.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult people above 25\n\nExclusion Criteria:\n\n* People deny to join the study'}, 'identificationModule': {'nctId': 'NCT01560806', 'briefTitle': 'Intervention Study on Hypertension Management Combined With Health Promotion at Commune Level', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Vietnam National Heart Institute'}, 'officialTitle': 'Quasi-experimental Intervention Study on Hypertension Management Combined With Comprehensive Healthy Lifestyle Promotion at Commune Level', 'orgStudyIdInfo': {'id': 'VNHI-07-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Conventional Healthcare services', 'description': 'People with high blood pressure detected during screening survey or opportunistically during study period will be referred to receive the conventional health care services for hypertension at district hospital or local commune health station'}, {'type': 'EXPERIMENTAL', 'label': 'Commune Hypertension Management', 'description': 'People with high blood pressure were managed in commune-based hypertension management programme', 'interventionNames': ['Other: Commune Hypertension Management']}], 'interventions': [{'name': 'Commune Hypertension Management', 'type': 'OTHER', 'otherNames': ['Commune-based Hypertension Management'], 'description': 'People with high blood pressure will be invited to join the management programme, with monthly check-up, delivery of multi anti-hypertensive drugs and lifestyle consultation.\n\nAntihypertensive drugs delivered to local patients included (1) low-dose hypothiazide diuresis, (2) calcium channel blocker and (3) ACEI', 'armGroupLabels': ['Commune Hypertension Management']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10000', 'city': 'Hanoi', 'state': 'Hanoi', 'country': 'Vietnam', 'facility': 'Vietnam National Heart Institute', 'geoPoint': {'lat': 21.0245, 'lon': 105.84117}}], 'overallOfficials': [{'name': 'Son T. Pham, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vietnam National Heart Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vietnam National Heart Institute', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}