Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2026-02-03 @ 2:08 AM
Study NCT ID:
NCT00569556
Status:
COMPLETED
Last Update Posted:
2009-06-15
First Post:
2007-12-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Care Management on Diabetes Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 550}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-11', 'studyFirstSubmitDate': '2007-12-05', 'studyFirstSubmitQcDate': '2007-12-05', 'lastUpdatePostDateStruct': {'date': '2009-06-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Combined outcome of BP<130/80 mmHG, HgbA1C<8%, and LDL<100mg/dl at 1 year; the primary analysis will compare the intervention to usual care with respect to the percentage of diabetic individuals achieving all three therapeutic goals', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'Safety of the intervention (occurence of adverse events over the course of the trial)', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus', 'Chronic Care Model', 'Case Management'], 'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '21636796', 'type': 'DERIVED', 'citation': 'Ishani A, Greer N, Taylor BC, Kubes L, Cole P, Atwood M, Clothier B, Ercan-Fang N. Effect of nurse case management compared with usual care on controlling cardiovascular risk factors in patients with diabetes: a randomized controlled trial. Diabetes Care. 2011 Aug;34(8):1689-94. doi: 10.2337/dc10-2121. Epub 2011 Jun 2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine if a nurse managed, protocol driven, disease management process for diabetes results in improved attainment of therapeutic goals for diabetes compared to usual care. It is hypothesized that implementation of the disease management process will improve the percentage of diabetic individuals attaining all three therapeutic targets (HgbA1C\\<8.0%, LDL\\<100mg/dl, and BP\\<130/80mmHG) by 10% compared to usual care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Enrolled at Minneapolis VAMC\n* Type 1 or 2 diabetes\n* Blood pressure at screening visit \\> 140mmHg systolic or \\> 90mmHg diastolic OR HgbA1C at screening visit \\> 9.0% OR LDL at screening visit \\> 100mg/dL\n\nExclusion Criteria:\n\n* Primary care provider unwilling to have participant included in study\n* Life expectancy \\< 1 year\n* Unable to give consent\n* Severe mental health condition\n* pregnant or planning on becoming pregnant'}, 'identificationModule': {'nctId': 'NCT00569556', 'briefTitle': 'Effect of Care Management on Diabetes Outcomes', 'organization': {'class': 'FED', 'fullName': 'Minneapolis Veterans Affairs Medical Center'}, 'officialTitle': 'Effect of Care Management on Diabetes Outcomes', 'orgStudyIdInfo': {'id': '3823-A'}, 'secondaryIdInfos': [{'id': 'VISN23'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Patients receive care through primary care provider', 'interventionNames': ['Other: Case Management']}, {'type': 'EXPERIMENTAL', 'label': 'Case Management', 'description': 'Specially trained nurse case managers contact patients by telephone; monitor blood pressure, LDL, and HgbA1C;, and recommend lifestyle and medication changes as needed', 'interventionNames': ['Other: Case Management']}], 'interventions': [{'name': 'Case Management', 'type': 'OTHER', 'description': 'Phone contact by specially trained nurse case managers; lifestyle recommendations and medication changes as needed', 'armGroupLabels': ['Case Management', 'Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55417', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapolis Veterans Affairs Medical Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Areef Ishani, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Minneapolis VAMC'}, {'name': 'Nacide Ercan-Fang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Minneapolis VAMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minneapolis Veterans Affairs Medical Center', 'class': 'FED'}, 'responsibleParty': {'oldNameTitle': 'Areef Ishani, MD, MS', 'oldOrganization': 'Minneapolis VAMC'}}}}