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Resilience-Based Diabetes Education for Type 2 Diabetes (TXSTRIDE Trial)
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Waitlist Available
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 belowSelect...
I am 18 years old or older.
Select...
I have been diagnosed with type 2 diabetes.
Select...
I am African American, over 18, with T2DM and an A1C of 6.5 or higher, and not in another T2DM program.
Select...
I am 18 years old or older.
Select...
I have been diagnosed with type 2 diabetes.
TXSTRIDE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 24 months
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 moreSecondary 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 moreTXSTRIDE 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.
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Who is running the clinical trial?
University of Texas at AustinLead Sponsor
358 Previous Clinical Trials
81,429 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I do not use any medication that contains glucocorticoids.Your A1C level must be 6.5 or higher.I do not have any health conditions that prevent me from changing my diet or exercising.I have been diagnosed with type 2 diabetes.Participants must be of African American descent.I am African American, over 18, with T2DM and an A1C of 6.5 or higher, and not in another T2DM program.I am 18 years old or older.I have been diagnosed with type 2 diabetes.You are of African American descent.Your A1C level is 6.5 or higher.
Research Study Groups:
This trial has the following groups:- Group 1: Resilience-Based Diabetes Self-Management Education
- Group 2: Standard Diabetes Self-Management Education
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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