Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2026-02-22 @ 4:52 PM
Study NCT ID:
NCT02762695
Status:
UNKNOWN
Last Update Posted:
2017-09-28
First Post:
2016-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of a Case Management Model for Patients With Hypertension and Type II Diabetes in Chile
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019090', 'term': 'Case Management'}], 'ancestors': [{'id': 'D010347', 'term': 'Patient Care Planning'}, {'id': 'D003191', 'term': 'Comprehensive Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 616}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-26', 'studyFirstSubmitDate': '2016-05-03', 'studyFirstSubmitQcDate': '2016-05-03', 'lastUpdatePostDateStruct': {'date': '2017-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycated Hemoglobin', 'timeFrame': 'One year'}, {'measure': 'Systolic and Diastolic Blood Pressure', 'timeFrame': 'One year'}], 'secondaryOutcomes': [{'measure': 'Quality of Care', 'timeFrame': 'one year', 'description': 'Measured by Clinical records audits'}, {'measure': 'Patient satisfaction', 'timeFrame': 'one year', 'description': 'Measured by a questionnaire'}, {'measure': 'Medication adherence', 'timeFrame': 'one year', 'description': 'Measured by Morisky- Green questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypertension', 'Diabetes Mellitus, Type 2', 'Case Management'], 'conditions': ['Hypertension', 'Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate whether a new model of health care for chronic patients, based on Case Management and guided by a nurse which targets the patient´s risk, is more effective than usual care at Primary Health care in Chile. Additionally, this intervention would provide a better quality of care and a more efficient health provision.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '82 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults diagnosed with Hypertension and/ or Type 2 Diabetes\n\nExclusion Criteria:\n\n* Severe mental illness and / or deterioration of cognitive abilities.\n* Severe hearing loss.\n* Diagnosed with cancer\n* Stage 4 or 5 of chronic kidney disease'}, 'identificationModule': {'nctId': 'NCT02762695', 'briefTitle': 'Effectiveness of a Case Management Model for Patients With Hypertension and Type II Diabetes in Chile', 'organization': {'class': 'OTHER', 'fullName': 'Pontificia Universidad Catolica de Chile'}, 'officialTitle': 'Evaluation of a Model of Care for People With Hypertension and Type II Diabetes Based on Case Management and Risk Adjustment', 'orgStudyIdInfo': {'id': '15-277'}, 'secondaryIdInfos': [{'id': 'ID15I10277', 'type': 'OTHER_GRANT', 'domain': 'FONDEF/CONICYT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Case Management', 'interventionNames': ['Other: Case Management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Usual Care at Primary Health Care', 'interventionNames': ['Other: Usual Care']}], 'interventions': [{'name': 'Case Management', 'type': 'OTHER', 'description': 'A model of health care for chronic patients, based on Case Management and guided by a nurse which targets the patient´s risk.\n\nThe core elements of this strategy are: a. processes to identify specific population and their risk; b. evidence-based practice guidelines according to risk (higher risk, more interventions and monitoring by a nurse, lower risk, higher emphasis on self-care); c. Practice models based on collaboration between health team members leaded by a nurse; d. self-management education for patients; e. monitoring patients face to face or by telephone to ensure to follow the care program (blood test, medical consultation, for example); e. measurement of process and outcomes.', 'armGroupLabels': ['Case Management']}, {'name': 'Usual Care', 'type': 'OTHER', 'description': 'Usual Care at Primary Health Care Center', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Peñalolén', 'state': 'RM', 'country': 'Chile', 'facility': 'CESFAM La Faena', 'geoPoint': {'lat': -33.46836, 'lon': -70.53411}}], 'overallOfficials': [{'name': 'Fernando C Poblete, Master', 'role': 'STUDY_CHAIR', 'affiliation': 'Pontificia Universidad Catolica de Chile'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pontificia Universidad Catolica de Chile', 'class': 'OTHER'}, 'collaborators': [{'name': 'Comisión Nacional de Investigación Científica y Tecnológica', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, MPH', 'investigatorFullName': 'Fernando Poblete Arrué', 'investigatorAffiliation': 'Pontificia Universidad Catolica de Chile'}}}}