Electronic Diabetes Tune-Up Group (eDTU) for African Americans: A Pragmatic Trial Phase 2
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Indiana University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Feasibility of intervention and delivery modality
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
The primary aims of this study are:
- 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).
- 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.
Investigators
Mary de Groot
Professor of Medicine
Indiana University
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
Outcomes
Primary Outcomes
Feasibility of intervention and delivery modality
Time Frame: During intervention (6-8 weeks)
Feasibility of electronic DTU intervention (eDTU) adapted for online delivery compared to the in-person DTU (iDTU) using participant attendance to intervention sessions; attendance will range from 1 to 6 sessions
Diabetes Distress Scale-17 (DDS-17)
Time Frame: To test differences in DDS-17 change scores between intervention (changes in baseline to 3-month follow-up) and waitlist control (change in enrollment to baseline) by intervention group (eDTU vs. waitlist control; iDTU vs. waitlist control).
Change in DDS-17 scores over time; scores range from 1 - 6 with higher scores indicating worse diabetes distress
HbA1c (A1c)
Time Frame: To test differences in A1c change scores between intervention (changes in baseline to 3-month follow-up) and waitlist control (change in enrollment to baseline) by intervention group (eDTU vs. waitlist control; iDTU vs. waitlist control).
Change in A1c values over time
Acceptability of intervention (content and delivery modality)
Time Frame: Immediately following intervention
Acceptability of electronic DTU intervention (eDTU) adapted for cultural relevance and online delivery compared to waitlist control and the in-person DTU (iDTU) using study-developed satisfaction questionnaire; scores can range from 15 - 75 with higher scores indicating greater participant satisfaction
Secondary Outcomes
- Patient Health Questionnaire-9 (PHQ-9)(Evaluate changes in depressive symptoms in intervention (baseline to 3-month follow-up) compared to waitlist control (enrollment to baseline). An exploratory aim will be to compare changes in eDTU to the iDTU pre/post intervention (baseline -3mo f/u).)
- Short Form-12 (SF-12)(Evaluate changes in general quality of life in intervention (baseline to 3mo f/u) compared to waitlist control (enrollment-baseline). An exploratory aim will be to compare changes in eDTU to the iDTU pre/post intervention (baseline to 3mo f/u).)
- Diabetes Therapy-Related Quality of Life Questionnaire(Evaluate changes in diabetes-specific quality of life in intervention (baseline to 3mo f/u) compared to waitlist control (enrollment-baseline). An exploratory aim will be to compare changes in eDTU to the iDTU pre/post intervention (baseline to 3mo f/u).)
- Confidence in Diabetes Self-Care (CDSC)(Evaluate changes in diabetes self-efficacy in intervention (baseline to 3-month follow-up) compared to waitlist control (enrollment to baseline).)