Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Indiana University Health | OTHER |
Not provided
Not provided
Not provided
Not provided
The primary aims of this study are:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-arm waitlist control | Experimental | The initial assessment will take place at the time of study enrollment (T1). Participants will be offered a choice of assignment to either the eDTU (online Diabetes Tune-Up Group intervention participation) or iDTU (in-person Diabetes Tune-Up Group intervention participation) series. After a 3-month waiting period, participants will complete baseline assessment (T2). The group intervention will then take place over the next 6 to 8 weeks. Immediately following completion of the intervention, participants will complete surveys (T3). A final assessment will be completed 3 months after baseline, approximately 4 to 6 weeks following the completion of the intervention (T4). The participant will participate in one series of the DTU intervention either, in person or online, at the participant's choosing. The intervention will take place over the course of 6 to 8 weeks. Participants will wear their continuous glucose monitor throughout the course of the intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabetes Tune-Up Group | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Diabetes Distress Scale-17 (DDS-17) | Change in DDS-17 scores over time; scores range from 1 - 6 with higher scores indicating worse diabetes distress | 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). |
| HbA1c (A1c) | Change in A1c values over time | 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). |
| Acceptability of intervention (content and delivery modality) | 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 | Immediately following intervention |
| Feasibility of intervention and delivery modality | 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 | During intervention (6-8 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 & three-month follow-up); scores range from 0 - 27 with higher scores indicating more severe depression symptoms | 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36661126 | Background | de Groot M, Myers BA, Baker L, Daily E, Cavaghan M. The Diabetes Tune-Up Group: A Multidisciplinary Approach to Improve Diabetes Distress and A1C Among Adults With Type 1 and Type 2 Diabetes. Sci Diabetes Self Manag Care. 2023 Apr;49(2):150-162. doi: 10.1177/26350106231151405. Epub 2023 Jan 20. |
Not provided
Not provided
The research team will submit a Material Transfer Agreement form to the National Institute for Diabetes and Digestive and Kidney Diseases (NIDDK) Repository to seek approval for depositing de-identified data collected from all time points of the study.
Within 18 months of completion of the project
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D048909 | Diabetes Complications |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Single group waitlist control
Not provided
Not provided
Not provided
Not provided
|
| Confidence in Diabetes Self-Care (CDSC) | 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 | Evaluate changes in diabetes self-efficacy in intervention (baseline to 3-month follow-up) compared to waitlist control (enrollment to baseline). |
| Short Form-12 (SF-12) | 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. | 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 (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 | 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). |
| D004700 | Endocrine System Diseases |