protocolSection identificationModule nctId: NCT06321029, orgStudyIdInfo id: 4-22-ICTSHD-44, briefTitle: Electronic Diabetes Tune-Up Group (eDTU) for African Americans, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-19, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Indiana University, class: OTHER, collaborators name: Indiana University Health, descriptionModule briefSummary: The primary aims of this study are:1. To test the acceptability and feasibility of the electronic DTU intervention (eDTU) that has been adapted for cultural relevance and online delivery compared to waitlist control and the in-person DTU (iDTU). The hypothesis is that the adapted intervention will be culturally acceptable (by participant satisfaction scores) and well-subscribed (intervention attendance rates).2. To test differences in diabetes distress and A1c change scores between intervention (changes in T2 to T4) and waitlist control (change in T1 to T2) by intervention group (eDTU vs. waitlist control; iDTU vs. waitlist control). The hypothesis is that both the eDTU and iDTU groups will show significant improvements in diabetes distress and A1c compared to waitlist control. In order to conserve sample size and budget, participants in each intervention group will serve as their own waitlist control.Secondary Objective. The secondary aim of the study is to evaluate changes in depressive symptoms, diabetes self-efficacy, and general and diabetes-specific quality of life in intervention (T2-T3 \& T4) compared to waitlist control (T1-T2). An exploratory aim will be to compare changes in eDTU to the iDTU pre/post intervention (T2-T3 \& T4). The hypothesis is that both groups will show comparable improvements in diabetes distress and A1c., conditionsModule conditions: Diabetes Mellitus, Type 2, conditions: Diabetes Complications, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Single group waitlist control, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Diabetes Tune-Up Group, outcomesModule primaryOutcomes measure: Diabetes Distress Scale-17 (DDS-17), primaryOutcomes measure: HbA1c (A1c), primaryOutcomes measure: Acceptability of intervention (content and delivery modality), primaryOutcomes measure: Feasibility of intervention and delivery modality, secondaryOutcomes measure: Patient Health Questionnaire-9 (PHQ-9), secondaryOutcomes measure: Confidence in Diabetes Self-Care (CDSC), secondaryOutcomes measure: Short Form-12 (SF-12), secondaryOutcomes measure: Diabetes Therapy-Related Quality of Life Questionnaire, eligibilityModule sex: FEMALE, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Indiana University School of Medicine, status: RECRUITING, city: Indianapolis, state: Indiana, zip: 46202, country: United States, contacts name: Barb Myers, MS, role: CONTACT, phone: 317-278-7339, email: bamyers@iu.edu, contacts name: Mary de Groot, PhD, role: CONTACT, phone: 317-278-1965, email: mdegroot@iu.edu, contacts name: Mary de Groot, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.76838, lon: -86.15804, hasResults: False