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Diabetes Education for Type 2 Diabetes
N/A
Recruiting
Led By Pearl McElfish, PhD
Research Sponsored by University of Arkansas
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosed with type 2 diabetes (HbA1c equal to or greater than 6.5%)
18 years of age or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, immediate post-intervention, 4 months post-intervention, 12 months post-intervention
Awards & highlights
Study Summary
This trial will test whether diabetes self-management education and support delivered in faith-based organizations by trained community health workers is effective in improving glycemic control for Marshallese people with type 2 diabetes.
Who is the study for?
This trial is for Marshallese adults with type 2 diabetes who have an HbA1c level of at least 6.5% and a family member to join them in the study. They shouldn't plan to move away, have conditions preventing protocol adherence, severe disabilities, or prior diabetes education within five years.Check my eligibility
What is being tested?
The study tests a Family Model Diabetes Self-Management Education program delivered by community health workers in churches. Participants are randomly assigned to start immediately or wait (wait-list control), measuring effects on blood sugar control and other health indicators.See study design
What are the potential side effects?
Since this intervention involves education and support rather than medication, typical drug side effects aren't expected. However, participants may experience stress or discomfort from lifestyle changes or frequent health monitoring required by the program.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have type 2 diabetes with an HbA1c of 6.5% or higher.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, immediate post-intervention, 4 months post-intervention, 12 months post-intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, immediate post-intervention, 4 months post-intervention, 12 months post-intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Glycemic control, measured by change in mean HbA1c (%) from baseline
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Family model diabetes self-management education and support
Group II: Wait-list ControlActive Control1 Intervention
Family model diabetes self-management education and support
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Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,358 Previous Clinical Trials
4,314,786 Total Patients Enrolled
University of ArkansasLead Sponsor
486 Previous Clinical Trials
150,065 Total Patients Enrolled
Pearl McElfish, PhDPrincipal InvestigatorUniversity of Arkansas
3 Previous Clinical Trials
3,080 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have type 2 diabetes with an HbA1c of 6.5% or higher.You are of Marshallese descent.I am 18 years old or older.I have received diabetes education in the last 5 years.I am able to follow the study's requirements without major health or sensory issues.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Wait-list Control
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this medical experiment currently seeking participants?
"The information hosted on clinicaltrials.gov reveals that this trial is not actively enrolling patients anymore; it was initially posted in April of 2023, then last updated in November 2022. However, there are currently 788 other trials searching for participants to join them."
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