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Completed
NCT06321029
Electronic Diabetes Tune-Up Group (eDTU) for African Americans
Conditions: Diabetes Mellitus, Type 2, Diabetes Complications
Sex: Female
Ages: 21 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 63
Sponsor: Indiana University
Location: Indiana University School of Medicine Indianapolis Indiana
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Age ≥ 21 years
* Self-identified Black or African American female
* Type 2 diabetes diagnosis ≥ 1 year
* A1c ≥ 7.0% in the past year per medical record or patient report
* DDS-17 score ≥ 2.0 at screening
* Active email address
Exclusion Criteria:
* Limited English language proficiency
* Presence of serious mental health disorder (e.g., psychotic disorders or severe mood disorders with suicidal ideation)
* Diagnosis of a major acute medical condition (e.g., myocardial infarction, stroke, cardiac rehabilitation, stage 3 or stage 4 cancer diagnoses) within the last three months
* Initiation of new medical treatment regimens (e.g., chemotherapy) for acute medical diagnoses that would require the patient's primary attention
Source: ClinicalTrials.gov (NCT06321029). StuddyBuddy aggregates publicly available trial information.