Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2026-02-20 @ 7:25 PM
Study NCT ID:
NCT00109369
Status:
COMPLETED
Last Update Posted:
2011-02-01
First Post:
2005-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vermont Diabetes Information System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D006937', 'term': 'Hypercholesterolemia'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D006943', 'term': 'Hyperglycemia'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'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': 'ESTIMATED', 'count': 7500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-31', 'studyFirstSubmitDate': '2005-04-27', 'studyFirstSubmitQcDate': '2005-04-26', 'lastUpdatePostDateStruct': {'date': '2011-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-04-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycemic control', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Processes of care', 'timeFrame': '2 years'}, {'measure': 'Blood pressure control', 'timeFrame': '2 years'}, {'measure': 'Hypercholesterolemia', 'timeFrame': '2 years'}, {'measure': 'Adherence to Practice Guidelines', 'timeFrame': '2 years'}, {'measure': 'Quality of life', 'timeFrame': '2 years'}, {'measure': 'Healthcare utilization', 'timeFrame': '2 years'}, {'measure': 'Patient satisfaction', 'timeFrame': '2 years'}, {'measure': 'Medication use', 'timeFrame': '2 years'}, {'measure': 'Functional status', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic Disease', 'Multi-Hospital Information Systems', 'Clinical Decision Support Systems', 'Reminder Systems', 'Registries', 'Quality of Healthcare', 'Guideline Adherence', 'Outcome and Process Assessment (Health Care)', 'Technology Assessment, Biomedical', 'Primary Health Care', 'Hypercholesterolemia', 'Hypertension', 'Hyperglycemia'], 'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '16279294', 'type': 'BACKGROUND', 'citation': 'MacLean CD, Littenberg B, Gagnon M, Reardon M, Turner PD, Jordan C. The Vermont Diabetes Information System (VDIS): study design and subject recruitment for a cluster randomized trial of a decision support system in a regional sample of primary care practices. Clin Trials. 2004;1(6):532-44. doi: 10.1191/1740774504cn051oa.'}]}, 'descriptionModule': {'briefSummary': 'The Vermont Diabetes Information System (VDIS) is a registry-based decision support and reminder system based on the Chronic Care Model and targeted to primary care physicians and their patients with diabetes. It will be evaluated by a randomized, controlled study in 60 Primary Care practices in Vermont and nearby New York.', 'detailedDescription': 'The long-term goal of the Vermont Diabetes Information System is to reduce morbidity and mortality from diabetes mellitus. The project will implement and evaluate a state-wide system to support evidence-based disease management by primary care providers, their practices, and their patients in the community. The primary study question is: "What is the effect of a Diabetes Information System (including education, feedback and decision support) upon disease control measured by glycated hemoglobin?" Secondary questions address the effect of the system upon adherence to guideline recommendations, blood pressure control, patient satisfaction, medication use, and functional status. We hypothesize that the information system will result in improvements in the process and outcomes of clinical care. There are two specific aims:\n\nAim 1: Implement the Diabetes Information System. Objective 1.1: Develop a registry of patients with diabetes in primary care practices in Vermont; Objective 1.2: Provide education and feedback to providers regarding their patients with diabetes; Objective 1.3: Deliver decision support (flow sheets, alerts and reminders) based on the registry and targeted at primary care providers and patients, to prompt ideal management of diabetes.\n\nAim 2: Assess the Diabetes Information System. Objective 2.1: Assess disease control and guideline adherence by examining registry data in all subjects in a prospective, two-year, randomized, controlled trial in 60 primary care practices; Objective 2.2: Assess outcomes (blood pressure control, obesity, functional status, symptoms, medication use, and satisfaction) by interview and examination in a sub-sample of patients from the controlled trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult\n* Diabetes confirmed by Primary Care provider\n\nExclusion Criteria:\n\n* Severe dementia\n* Nursing home resident'}, 'identificationModule': {'nctId': 'NCT00109369', 'briefTitle': 'Vermont Diabetes Information System', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}, 'officialTitle': 'Vermont Diabetes Information System', 'orgStudyIdInfo': {'id': '61167 (completed)'}, 'secondaryIdInfos': [{'id': 'R01DK061167', 'link': 'https://reporter.nih.gov/quickSearch/R01DK061167', 'type': 'NIH'}, {'id': 'K24DK068380', 'link': 'https://reporter.nih.gov/quickSearch/K24DK068380', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active', 'description': 'Provider and patient receive Diabetes Information System services', 'interventionNames': ['Other: Information and decision support for providers and patients']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Usual Care'}], 'interventions': [{'name': 'Information and decision support for providers and patients', 'type': 'OTHER', 'otherNames': ['Vermedx Diabetes Information System'], 'description': 'Laboratory-based decision support, reminders, and population report cards.', 'armGroupLabels': ['Active']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'University of Vermont', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}], 'overallOfficials': [{'name': 'Benjamin Littenberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Vermont'}, {'name': 'Charles D. MacLean, MDCM', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Vermont'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, 'collaborators': [{'name': 'Vermont Program for Quality in Health Care', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Benjamin Littenberg, Professor', 'oldOrganization': 'University of Vermont'}}}}