Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-02-23 @ 1:11 AM
Study NCT ID:
NCT00848705
Status:
COMPLETED
Last Update Posted:
2011-02-02
First Post:
2009-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adolescent Self-Management of Type 1 Diabetes: an Intervention (Completed)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], '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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-31', 'studyFirstSubmitDate': '2009-02-19', 'studyFirstSubmitQcDate': '2009-02-19', 'lastUpdatePostDateStruct': {'date': '2011-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-management behaviors', 'timeFrame': 'End of intervention'}], 'secondaryOutcomes': [{'measure': 'Self-management Problem solving', 'timeFrame': 'end of study period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['type 1 diabetes, adolescent, self-management'], 'conditions': ['Adolescent Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': 'The goals of this R21 exploratory pilot and feasibility study were to: 1) design an Internet-based self-management intervention for adolescents with type 1 diabetes; 2) test that intervention in a small randomized trial to establish technical feasibility, intervention acceptability, and competence in completing the necessary recruitment and research procedures. Although not powered to detect statistically significant changes, possible outcomes of this study include improvements in problem-solving, coping, and self-management behaviors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:diagnosed for at least 6 months, age 13-17; Internet access, parental consent -\n\nExclusion Criteria: Any sensory deficits that would preclude seeing or hearing.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00848705', 'acronym': 'YourWay', 'briefTitle': 'Adolescent Self-Management of Type 1 Diabetes: an Intervention (Completed)', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)'}, 'officialTitle': 'Adolescent Self-Management of Type 1 Diabetes: an Intervention', 'orgStudyIdInfo': {'id': 'DK70026-01A2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Measurement Only', 'interventionNames': ['Behavioral: YourWay Internet Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Internet Intervention', 'interventionNames': ['Behavioral: YourWay Internet Intervention']}], 'interventions': [{'name': 'YourWay Internet Intervention', 'type': 'BEHAVIORAL', 'description': 'The intervention is an 11 week program that teaches problem solving of barriers to self-management.', 'armGroupLabels': ['Internet Intervention', 'Measurement Only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37240', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}, 'responsibleParty': {'oldNameTitle': 'Shelagh Mulvaney, PhD', 'oldOrganization': 'Vanderbilt University Medical Center'}}}}