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Resilience-Based Diabetes Education for Type 2 Diabetes (TXSTRIDE Trial)

N/A
Recruiting
Led By Sharon A. Brown, PhD
Research Sponsored by University of Texas at Austin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be 18 years of age or older
be diagnosed with T2DM;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 24 months
Awards & highlights

TXSTRIDE Trial Summary

This trial program seeks to help African Americans with type 2 diabetes better manage their disease by improving their self-management skills and resilience.

Who is the study for?
This trial is for African American adults over 18 with Type 2 Diabetes Mellitus (T2DM), who have an A1C level of 6.5 or higher and are not currently in another T2DM management program. Pregnant/lactating individuals, those with certain medical conditions, or those on glucocorticoid medication cannot participate.Check my eligibility
What is being tested?
The study compares Resilience-Based Diabetes Self-Management Education (RB-DSME) to Standard Diabetes Self-Management Education among African Americans. It aims to integrate resilience resources with diabetes self-management skills to improve health outcomes.See study design
What are the potential side effects?
Since the interventions involve education and lifestyle changes rather than medications, typical drug side effects are not expected. However, changes in diet and activity levels may cause discomfort or require adjustment periods.

TXSTRIDE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been diagnosed with type 2 diabetes.
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I am African American, over 18, with T2DM and an A1C of 6.5 or higher, and not in another T2DM program.
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I am 18 years old or older.
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I have been diagnosed with type 2 diabetes.

TXSTRIDE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in depressive symptoms at 12 months
Change from baseline in depressive symptoms at 24 months
Depressive Symptoms
+3 more
Secondary outcome measures
Change from baseline in adaptation to stress at 12 months
Change from baseline in adaptation to stress at 6 months
Change from baseline in adaptive coping strategies at 12 months
+47 more

TXSTRIDE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Resilience-Based Diabetes Self-Management EducationExperimental Treatment1 Intervention
The RB-DSME structure involves 8 weekly classes, 8 bimonthly support group sessions, and 2 booster sessions. The RB-DSME builds on foundational resilience resources (e.g., self-efficacy, social support), infusing novel resilience resources (e.g., adaptation to stress, finding positive meaning, spiritual coping) into the RB-DSME curriculum.
Group II: Standard Diabetes Self-Management EducationActive Control1 Intervention
The scope and sequence of the standard diabetes self-management education (DSME) curriculum are aligned with national standards of the American Diabetes Association. DSME groups receive a 10-month intervention: 8 weekly educational sessions, followed by 8 bimonthly support group sessions, followed by 2 booster sessions.

Find a Location

Who is running the clinical trial?

University of Texas at AustinLead Sponsor
353 Previous Clinical Trials
80,924 Total Patients Enrolled
Sharon A. Brown, PhDPrincipal InvestigatorUniversity of Texas at Austin
1 Previous Clinical Trials
300 Total Patients Enrolled
Mary A. Steinhardt, EdDPrincipal InvestigatorUniversity of Texas at Austin

Media Library

Resilience-Based Diabetes Self-Management Education Clinical Trial Eligibility Overview. Trial Name: NCT04282395 — N/A
Type 2 Diabetes Research Study Groups: Resilience-Based Diabetes Self-Management Education, Standard Diabetes Self-Management Education
Type 2 Diabetes Clinical Trial 2023: Resilience-Based Diabetes Self-Management Education Highlights & Side Effects. Trial Name: NCT04282395 — N/A
Resilience-Based Diabetes Self-Management Education 2023 Treatment Timeline for Medical Study. Trial Name: NCT04282395 — N/A

Frequently Asked Questions

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

Are people currently able to sign up for the trial?

"The trial, which was posted on 1/25/2020, is still looking for participants according to the most recent update on 11/1/2022."

Answered by AI

What are the aim and objectives of this research?

"The primary aim of this study, which will be conducted over the course of Baseline and 6 months, is to observe the Change from baseline in depressive symptoms at 24 months. Additionally, the study will also assess the Change from baseline in general perceived stress at 6 months, Change from baseline in physiological stress (HPA axis function) at 12 months, and Change from baseline in body mass index (BMI) at 12 months."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
University of Texas at Austin
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Average response time
  • < 1 Day
Typically responds via
Email
Phone Call
Most responsive sites:
  1. University of Texas at Austin: < 24 hours
~56 spots leftby Apr 2025