Electronic Diabetes Tune-Up Group (eDTU) for African Americans
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.
Conditions:
🦠 Diabetes Mellitus, Type 2 🦠 Diabetes Complications
🗓️ Study Start (Actual) 19 October 2023
🗓️ Primary Completion (Estimated) 31 December 2024
✅ Study Completion (Estimated) 31 March 2025
👥 Enrollment (Estimated) 60
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Indianapolis, Indiana, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 21 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 4 January 2024
  • First Submitted that Met QC Criteria 13 March 2024
  • First Posted 20 March 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 13 March 2024
  • Last Update Posted 20 March 2024
  • Last Verified March 2024