Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2026-01-07 @ 6:21 AM
Study NCT ID:
NCT00629434
Status:
TERMINATED
Last Update Posted:
2021-10-06
First Post:
2008-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison of Diabetes Group Education as Administered Through Telemedicine Versus as Administered in Person
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2001-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-05', 'studyFirstSubmitDate': '2008-02-25', 'studyFirstSubmitQcDate': '2008-03-04', 'lastUpdatePostDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A1c', 'timeFrame': 'baseline, 3 mo post intervention, 6 mo post intervention'}], 'secondaryOutcomes': [{'measure': 'PAID scale', 'timeFrame': 'baseline, 3 and 6 months post intervention'}, {'measure': 'Diabetes Treatment Satisfaction Questionnaire', 'timeFrame': 'Baseline, 3 and 6 months post intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes Education', 'Telemedicine'], 'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This study compares group diabetes education in-person versus via telemedicine', 'detailedDescription': 'Diabetes education is important in the treatment of the person with diabetes. A diabetes self-management education program not only educates the patient and his/her family to the basics of diabetes care but also integrates diabetes care into daily life while providing coping skills to adjust to this chronic illness. Unfortunately, comprehensive diabetes care is not available to all persons with diabetes. One obstacle to the provision of comprehensive diabetes care is the unavailability of a diabetes treatment center. many people with diabetes live too far or do not have the transportation to be able to attend education programs that met national standards. We have shown that telemedicine is an effective means to provide comprehensive 1:1 individualized diabetes education to persons with diabetes. We now propose to test the hypothesis that diabetes groups education classes can be provided effectively through telemedicine technology to individuals living in rural areas. Patients with diabetes will received diabetes education via teleconferencing from our Joslin Diabetes center. The participants will be assessed before and after diabetes education via telemedicine using measures of glycemia (A1c) and assessments of patient satisfaction, emotional well being, and behavioral change and compared to results from participants attending our diabetes education classes in-person.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 or type 2 diabetes mellitus\n* age \\> 18 years\n\nExclusion Criteria:\n\n* Profound vision loss\n* Severe hearing impairment'}, 'identificationModule': {'nctId': 'NCT00629434', 'briefTitle': 'A Comparison of Diabetes Group Education as Administered Through Telemedicine Versus as Administered in Person', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York - Upstate Medical University'}, 'officialTitle': 'A Comparison of Diabetes Group Education as Administered Through Telemedicine Versus as Administered in Person', 'orgStudyIdInfo': {'id': 'UMU IRB # 4510F'}, 'secondaryIdInfos': [{'id': 'UMU IRB # 4510F'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'This arm will receive diabetes education via telemedicine', 'interventionNames': ['Other: diabetes education via telemedicine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'diabetes education in-person', 'interventionNames': ['Other: diabetes education in-person']}], 'interventions': [{'name': 'diabetes education via telemedicine', 'type': 'OTHER', 'description': 'This arm will receive diabetes group education via telemedicine', 'armGroupLabels': ['1']}, {'name': 'diabetes education in-person', 'type': 'OTHER', 'description': 'In this arm the group of patients with diabetes will receive diabetes education in-person', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13214', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'Joslin Diabetes Center Affiliate at SUNY Upstate Medical University', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York - Upstate Medical University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Roberto Izquierdo, MD', 'oldOrganization': 'SUNY Upstate Medical University'}}}}