Electronic Diabetes Tune-Up Group (eDTU) for African Americans

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Electronic Diabetes Tune-Up Group (eDTU) for African Americans: A Pragmatic Trial Phase 2

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06321029
• Other study ID #: 4-22-ICTSHD-44
• Status: Recruiting
• Phase: N/A
• Start date: October 19, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: March 2024
• Source: Indiana University
• Contact: Barb Myers, MS
• Phone: 317-278-7339
• Email: bamyers[@]iu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Complications
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Diabetes 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.

Locations

Country	Name	City	State
United States	Indiana University School of Medicine	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Indiana University Health

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Primary	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
Primary	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)
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).