Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2026-02-18 @ 1:35 AM
Study NCT ID:
NCT02274103
Status:
COMPLETED
Last Update Posted:
2014-10-24
First Post:
2014-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Skype for Youth With Poorly Controlled Diabetes
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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-23', 'studyFirstSubmitDate': '2014-10-21', 'studyFirstSubmitQcDate': '2014-10-23', 'lastUpdatePostDateStruct': {'date': '2014-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': 'Change from Baseline to 3 months and from 3 months to 6 months', 'description': 'HbA1c values for both intervention groups improved from baseline to 3 months and from 3 months to 6 months.'}], 'secondaryOutcomes': [{'measure': 'Adherence to diabetes treatment using the Diabetes Self Management Profile (DSMP) (Harris et al, 2001).', 'timeFrame': 'Change from Baseline to 3 months and from 3 months to 6 months', 'description': 'DSMP scores for both intervention groups improved from baseline to 3 months and from 3 months to 6 months.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes']}, 'referencesModule': {'references': [{'pmid': '27075708', 'type': 'DERIVED', 'citation': 'Duke DC, Wagner DV, Ulrich J, Freeman KA, Harris MA. Videoconferencing for Teens With Diabetes: Family Matters. J Diabetes Sci Technol. 2016 Jun 28;10(4):816-23. doi: 10.1177/1932296816642577. Print 2016 Jul.'}, {'pmid': '26033508', 'type': 'DERIVED', 'citation': 'Harris MA, Freeman KA, Duke DC. Seeing Is Believing: Using Skype to Improve Diabetes Outcomes in Youth. Diabetes Care. 2015 Aug;38(8):1427-34. doi: 10.2337/dc14-2469. Epub 2015 Jun 1.'}, {'pmid': '26015558', 'type': 'DERIVED', 'citation': 'Riley AR, Duke DC, Freeman KA, Hood KK, Harris MA. Depressive Symptoms in a Trial Behavioral Family Systems Therapy for Diabetes: A Post Hoc Analysis of Change. Diabetes Care. 2015 Aug;38(8):1435-40. doi: 10.2337/dc14-2519. Epub 2015 May 26.'}]}, 'descriptionModule': {'briefSummary': "Compared family-based skills training (aka, Behavioral Family Systems Therapy) to youth with poorly controlled type 1 diabetes and their parents either face-to-face or over SkypeTM. Examined the differential impact on the youth's adherence to the diabetes medical regimen and the youth's blood sugar control."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Youth between the ages of 12 and 18 with type 1 diabetes characterized by an HbA1c value great than 9%\n* Caregivers willing to participate\n* Family members reading English at 5th grade level\n* Willing to be randomized.\n\nExclusion Criteria:\n\n* Youth with intellectual disability\n* Parent or youth who doesn't speak English"}, 'identificationModule': {'nctId': 'NCT02274103', 'acronym': 'SKYPE', 'briefTitle': 'Skype for Youth With Poorly Controlled Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Oregon Health and Science University'}, 'officialTitle': 'Improving Health Through SkypeTM: Family-Based Intervention for Teens With Poorly Controlled Diabetes', 'orgStudyIdInfo': {'id': '6000'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Clinic', 'description': 'BFST delivered to youth with poorly controlled diabetes and their families in the clinic, face-to-face.', 'interventionNames': ['Behavioral: BFST']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Skype', 'description': 'BFST delivered to youth with poorly controlled diabetes and their families using Skype.', 'interventionNames': ['Behavioral: BFST']}], 'interventions': [{'name': 'BFST', 'type': 'BEHAVIORAL', 'description': 'Family-based skills training.', 'armGroupLabels': ['Clinic', 'Skype']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oregon Health and Science University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Pediatrics', 'investigatorFullName': 'Michael A. Harris, PhD', 'investigatorAffiliation': 'Oregon Health and Science University'}}}}