Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT01339520
Status:
COMPLETED
Last Update Posted:
2017-08-11
First Post:
2011-04-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diabetes Scorecard Educational Intervention Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-10', 'studyFirstSubmitDate': '2011-04-19', 'studyFirstSubmitQcDate': '2011-04-19', 'lastUpdatePostDateStruct': {'date': '2017-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in total score', 'timeFrame': '9 months', 'description': 'The total score was calculated by points assigned to variables (systolic blood pressure, diastolic blood pressure, HbA1c, aspirin usage and daily exercise). The maximal score of 100 corresponds to all variables at target. Fewer points were assigned to higher blood pressure, worse HbA1c levels, less exercise, etc.'}], 'secondaryOutcomes': [{'measure': 'LDL-cholesterol', 'timeFrame': '9 months'}, {'measure': 'HbA1c', 'timeFrame': '9 months', 'description': 'Measure of glycemic control'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '22332914', 'type': 'DERIVED', 'citation': 'Irwig MS, Sood P, Ni D, Amass T, Khurana PS, Jayanthi VV, Wang L, Adler SM. A diabetes scorecard does not improve HbA(1c), blood pressure, lipids, aspirin usage, exercise and diabetes knowledge over 9 months: a randomized controlled trial. Diabet Med. 2012 Sep;29(9):1206-12. doi: 10.1111/j.1464-5491.2012.03610.x.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if the use of a diabetic scorecard during clinic visits can improve glycemic control, blood pressure control, LDL-cholesterol, aspirin usage, and amount of exercise in adults over age 40 with uncontrolled Type II diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Uncontrolled Type II diabetes (HbA1c ≥ 8%)\n\nExclusion Criteria:\n\n* Type I Diabetes\n* HbA1c \\< 8%\n* Inability to understand the diabetes scorecard due to condition (i.e. dementia, mental retardation, etc) or language barrier\n* Pregnancy\n* Planning to move within the next year'}, 'identificationModule': {'nctId': 'NCT01339520', 'briefTitle': 'Diabetes Scorecard Educational Intervention Study', 'organization': {'class': 'OTHER', 'fullName': 'George Washington University'}, 'officialTitle': 'Use of a Card to Improve Risk Factor Control in Patients With Type II Diabetes', 'orgStudyIdInfo': {'id': 'DiabetesScorecardStudy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Scorecard', 'description': 'Score of points for variables.', 'interventionNames': ['Behavioral: Scorecard', 'Behavioral: Control']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Standard of care for diabetes subjects'}], 'interventions': [{'name': 'Scorecard', 'type': 'BEHAVIORAL', 'description': 'Points were assigned for blood pressure, HbA1c level, LDL-cholesterol level, aspirin use and exercise level.', 'armGroupLabels': ['Scorecard']}, {'name': 'Control', 'type': 'BEHAVIORAL', 'description': 'Standard of care for diabetes subjects', 'armGroupLabels': ['Scorecard']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20037', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Medical Faculty Associates, George Washington University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'George Washington University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Physician', 'investigatorFullName': 'Michael Irwig', 'investigatorAffiliation': 'George Washington University'}}}}