Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-01-09 @ 9:08 PM
Study NCT ID:
NCT00469105
Status:
COMPLETED
Last Update Posted:
2010-04-23
First Post:
2007-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Care for Primary Care Patients With Diabetes and Poor Literacy and Numeracy Skills
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-04', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-04-22', 'studyFirstSubmitDate': '2007-05-03', 'studyFirstSubmitQcDate': '2007-05-03', 'lastUpdatePostDateStruct': {'date': '2010-04-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A1C', 'timeFrame': '3 and 6 months'}], 'secondaryOutcomes': [{'measure': 'Patient self-management behaviors', 'timeFrame': '3 and 6 months'}, {'measure': 'Patient knowledge', 'timeFrame': '6 months'}, {'measure': 'Patient satisfaction', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type 2 Diabetes', 'Diabetes Education', 'Health Literacy'], 'conditions': ['Type 2 Diabetes']}, 'referencesModule': {'references': [{'pmid': '19741187', 'type': 'DERIVED', 'citation': 'Cavanaugh K, Wallston KA, Gebretsadik T, Shintani A, Huizinga MM, Davis D, Gregory RP, Malone R, Pignone M, DeWalt D, Elasy TA, Rothman RL. Addressing literacy and numeracy to improve diabetes care: two randomized controlled trials. Diabetes Care. 2009 Dec;32(12):2149-55. doi: 10.2337/dc09-0563. Epub 2009 Sep 9.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this research will be to perform a small randomized controlled trial (RCT) of a new diabetes educational intervention that teaches self-management skills that compensate for poor numeracy skills among a sample of primary care patients with type 2 diabetes and low literacy and/or numeracy.', 'detailedDescription': 'Results of the National Adult Literacy Survey (NALS) suggest that over 90 million adult Americans have poor quantitative skills. Numeracy, the ability to understand and use numbers and math skills in daily life, may be particularly important to patients with diabetes because caring for diabetes often requires self-management skills that rely on the daily application of math skills, such as counting carbohydrates, interpreting blood glucose monitoring, applying sliding scale insulin regimens, and calculating insulin to carbohydrate ratios. Presumably diabetes patients with poor numeracy have more difficulty with self-management and are at risk for poorer clinical outcomes, but to date, there are no published studies that rigorously examine the role of numeracy in diabetes. We have recently completed the initial development of a new scale to measure numeracy in patients with diabetes: the Diabetes Numeracy Test (DNT).\n\nThe aim of this research will be to perform a small randomized controlled trial (RCT) of a new diabetes educational intervention that teaches self-management skills that compensate for poor literacy and numeracy skills among a sample of patients with type 2 diabetes and low numeracy or literacy skills. We hypothesize that a group of patients with poor literacy and/or numeracy who are taught self-management skills that accommodate their poor numeracy will have: (1) improved treatment satisfaction and perceived self-efficacy, (2) improved performance in self-management tasks, and (3) improved glycemic control compared to a control group that receives usual education and care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Clinical diagnosis of Type 2 Diabetes\n2. most recent A1C \\>= 7.5%\n3. Referred to the Diabetes Care Program for diabetes care\n4. Age 18-85; 5. English Speaking.\n\nExclusion Criteria:\n\n1. Patients with corrected visual Acuity \\>20/50 using a Rosenbaum Pocket Vision Screener\n2. Patients with a diagnosis of significant dementia, psychosis, or blindness.'}, 'identificationModule': {'nctId': 'NCT00469105', 'briefTitle': 'Improving Care for Primary Care Patients With Diabetes and Poor Literacy and Numeracy Skills', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University'}, 'officialTitle': 'Improving Care for Primary Care Patients With Diabetes and Poor Literacy and Numeracy Skills', 'orgStudyIdInfo': {'id': '7-04-NN-16 (ADA)'}, 'secondaryIdInfos': [{'id': 'Vanderbilt IRB: 040387'}, {'id': 'UNC IRB: 06-0535'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Control Arm receives standard diabetes disease management', 'interventionNames': ['Behavioral: Control Group']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Arm', 'description': 'Receives numeracy/literacy sensitive diabetes management', 'interventionNames': ['Behavioral: Literacy/Numeracy oriented educational intervention']}], 'interventions': [{'name': 'Literacy/Numeracy oriented educational intervention', 'type': 'BEHAVIORAL', 'description': 'Receives comprehensive literacy/num sensitive diabetes care', 'armGroupLabels': ['Intervention Arm']}, {'name': 'Control Group', 'type': 'BEHAVIORAL', 'description': 'Receives standard diabetes disease management', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina at Chapel Hill, General Medicine Clinic', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Robb Malone, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}, {'name': 'Russell L Rothman, MD MPP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, {'name': 'American Diabetes Association', 'class': 'OTHER'}, {'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Russell Rothman', 'oldOrganization': 'Vanderbilt University'}}}}