Diabetes Complications, Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes Distress
Brief 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.
Interventions
BEHAVIORALDiabetes Tune-Up Group
The eDTU and iDTU interventions will consist of 6 weekly group sessions lasting 90 minutes per session offered over a 6-8 week period. Each series will be co-facilitated by one diabetes care and education specialist and one behavioral health interventionist. Enrollment in each series will consist of 4-10 patients per group. The intervention components integrate key strategies that have been demonstrated to be effective in previous studies: motivational interviewing and introduction to stages of change; diabetes education; cognitive behavioral therapy with a particular emphasis on identification of cognitive distortions, thought stopping and cognitive reframing; emotional regulation; social support and miscarried helping; and behavioral strategies to support diabetes self-management. Each session will involve a psychoeducational portion, group discussion, and take-home assignments to be completed between sessions.
Sponsors
Indiana University
Indiana University Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single group waitlist control
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes Distress Scale-17 (DDS-17) | 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) | 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) | 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 |
| Feasibility of intervention and delivery modality | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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 \& three-month follow-up); scores range from 0 - 27 with higher scores indicating more severe depression symptoms |
| 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). | Evaluate changes in diabetes self-efficacy in intervention (baseline to 3mo f/u) 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); scores ranges from 20 - 100 with higher scores indicative of greater patient belief in caring for their diabetes |
| 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). | Evaluate changes in general quality of life in intervention (baseline to 3mo f/u) 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); Items are divided into 2 subscales, the Physical Component and Mental Component scores, total item and subscale scores are converted to a 100-point scale, with higher scores indicating better functioning. |
| 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). | Evaluate changes in diabetes-specific quality of life in intervention (baseline to 3mo f/u) 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); scores range from 17 - 68 with higher scores reflecting greater diabetes-specific quality of life |
Countries
United States
Outcome results
None listed