Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2026-01-01 @ 10:51 PM
Study NCT ID:
NCT01344668
Status:
COMPLETED
Last Update Posted:
2016-10-14
First Post:
2011-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Public Private Partnership Addressing Literacy-Numeracy to Improve Diabetes Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 411}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-12', 'studyFirstSubmitDate': '2011-04-27', 'studyFirstSubmitQcDate': '2011-04-28', 'lastUpdatePostDateStruct': {'date': '2016-10-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in A1C at 12 months', 'timeFrame': '12 months', 'description': 'The primary outcome will be the improvement in A1C at 12 months between Intervention group patients and Control group patients.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Diabetes'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The primary hypotheses are that the intervention will improve A1C, blood pressure, lipids, weight, self-efficacy, self-management behaviors, and use of clinical services at 12 and 24 months follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has a clinical diagnosis of Type 2 Diabetes\n* Age 18-85 years\n* English or Spanish speaking\n* Most recent A1C ≥ 7.5%\n* Patient agrees to participate in the study for the full two years duration.\n\nExclusion Criteria:\n\n* Poor visual acuity (vision worse than 20/50 using Rosenbaum Pocket Screener) -- Significant dementia or psychosis (by health provider report or chart review)\n* Terminal illness with anticipated life expectancy \\< 2 years (per health provider or patient report).'}, 'identificationModule': {'nctId': 'NCT01344668', 'acronym': 'PRIDE', 'briefTitle': 'The Public Private Partnership Addressing Literacy-Numeracy to Improve Diabetes Care', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University'}, 'officialTitle': 'The Public Private Partnership Addressing Literacy-Numeracy to Improve Diabetes Care', 'orgStudyIdInfo': {'id': '101523'}, 'secondaryIdInfos': [{'id': '1R18DK083264-01A2', 'link': 'https://reporter.nih.gov/quickSearch/1R18DK083264-01A2', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Standard Diabetes Education', 'description': 'Standard Diabetes Education', 'interventionNames': ['Other: Standard Diabetes Education']}, {'type': 'OTHER', 'label': 'Enhanced Diabetes Education', 'description': 'Enhanced Diabetes Education', 'interventionNames': ['Other: Enhanced Diabetes Education']}], 'interventions': [{'name': 'Enhanced Diabetes Education', 'type': 'OTHER', 'description': 'Provide enhanced diabetes education', 'armGroupLabels': ['Enhanced Diabetes Education']}, {'name': 'Standard Diabetes Education', 'type': 'OTHER', 'description': 'Provide Standard Diabetes Education', 'armGroupLabels': ['Standard Diabetes Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Russell L. Rothman, MD, MPP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Russell Rothman', 'investigatorAffiliation': 'Vanderbilt University'}}}}