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

NCT06321029 | Active Not Recruiting

• 1 other identifier: 4-22-ICTSHD-44
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aims of this study are:

1. 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. 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.

Conditions

Diabetes Mellitus, Type 2; Diabetes Complications

Keywords

Diabetes Distress

Outcome Measures

Primary Outcomes (4)

• 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)

Secondary Outcomes (4)

• 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).

• 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).

• 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).

Study Arms (1)

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.

Behavioral: Diabetes Tune-Up Group

Interventions

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.

Single-arm waitlist control

Eligibility Criteria

• Age: 21 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• Indiana University Health: collaborator

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Related 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.

  PMID: 36661126 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Complications

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: Single group waitlist control

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: March 20, 2024
• Study Start: October 19, 2023
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Within 18 months of completion of the project

Locations

US (1)