Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2025-12-26 @ 4:04 PM
Study NCT ID:
NCT06577506
Status:
COMPLETED
Last Update Posted:
2025-04-10
First Post:
2023-11-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diabetes Education and Care for Deaf Populations
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2023-11-07', 'studyFirstSubmitQcDate': '2024-08-26', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A1C Level', 'timeFrame': '6 months: (Test at 0 weeks, 12 weeks, and 24 weeks)', 'description': 'Clinical outcome'}], 'secondaryOutcomes': [{'measure': 'Diabetes Distress Level Using the Screening Scale Questionnaire', 'timeFrame': '6 months: (Test at 0 weeks, 12 weeks, and 24 weeks)', 'description': 'Psychosocial outcome, scoring averaged from 1-6 with higher score means worse outcome.'}, {'measure': 'Diabetes Self-Care Level using the Self-Care Inventory Revised Questionnaire', 'timeFrame': '6 months: (Test at 0 weeks, 12 weeks, and 24 weeks)', 'description': 'Self-management outcome, scoring averaged from 0-100 point scale with higher score means better outcome.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes']}, 'descriptionModule': {'briefSummary': 'This study will assess the feasibility and preliminary efficacy of a 10-week intervention called "Deaf Diabetes Can Together".'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Identify as Deaf/Hard of Hearing\n* living with diabetes (any type)\n* speak and understand English or American Sign Language\n* have access to internet\n* willing to participate in the intervention\n\nExclusion Criteria:\n\n* participating in another diabetes study\n* have significant cognitive impairment\n* are pregnant or planning to become pregnant in the next year\n* have life expectancy of \\<6 months'}, 'identificationModule': {'nctId': 'NCT06577506', 'briefTitle': 'Diabetes Education and Care for Deaf Populations', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Improving Access to Diabetes Education and Care for Deaf Populations', 'orgStudyIdInfo': {'id': '00151575'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Deaf Diabetes Can Together', 'interventionNames': ['Behavioral: Deaf Diabetes Can Together']}], 'interventions': [{'name': 'Deaf Diabetes Can Together', 'type': 'BEHAVIORAL', 'description': '10-week diabetes self-management telehealth intervention for deaf adults with diabetes.', 'armGroupLabels': ['Deaf Diabetes Can Together']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Michelle Litchman', 'investigatorAffiliation': 'University of Utah'}}}}