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Behavioural Intervention

Single-arm waitlist control for Type 2 Diabetes

N/A

Recruiting

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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).

Awards & highlights

Study Summary

This trial aims to test a culturally adapted electronic diabetes intervention compared to in-person intervention and a waitlist control group. The study will assess the intervention's acceptability, feasibility, and effectiveness in improving diabetes

Who is the study for?

This trial is for African Americans with diabetes, including Type 2 Diabetes. Participants should be interested in joining a group program to manage their condition either online or in-person. Specific eligibility details are not provided, but typically participants would need to meet certain health criteria and commit to the study's schedule.Check my eligibility

What is being tested?

The study is testing an electronic 'Diabetes Tune-Up' group intervention (eDTU) adapted for cultural relevance and online delivery against a waitlist control and an in-person version of the same program (iDTU). It aims to see if these programs can reduce diabetes distress and improve blood sugar control as measured by A1c levels.See study design

What are the potential side effects?

Since this trial involves educational interventions rather than medications, traditional side effects are not expected. However, participants may experience varying levels of stress or emotional discomfort related to managing their diabetes during the course of the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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).

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability of intervention (content and delivery modality)

Diabetes Distress Scale-17 (DDS-17)

Feasibility of intervention and delivery modality

+1 more

Secondary outcome measures

Confidence in Diabetes Self-Care (CDSC)

Diabetes Therapy-Related Quality of Life Questionnaire

Patient Health Questionnaire-9 (PHQ-9)

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single-arm waitlist controlExperimental Treatment1 Intervention

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

981,702 Total Patients Enrolled

Indiana University HealthOTHER

30 Previous Clinical Trials

15,973 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently able to apply and participate in this ongoing medical trial?

"According to the details available on clinicaltrials.gov, this study is actively seeking eligible participants. It was initially listed on 10/19/2023 and most recently revised on 3/13/2024."

Answered by AI

What is the current number of participants who are being recruited for this research study?

"Indeed, the details on clinicaltrials.gov indicate that this clinical investigation is actively seeking volunteers. The trial was initially published on October 19th, 2023 and underwent its latest revision on March 13th, 2024. They aim to enroll a total of 60 participants from one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Mary de Groot 2023. "Electronic Diabetes Tune-Up Group (eDTU) for African Americans". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06321029.

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