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Diabetes Self-Management Education for Diabetes (FDSMEFBO Trial)

N/A

Recruiting

Led By Pearl McElfish, Phd, MDA

Research Sponsored by University of Arkansas

Eligibility Criteria Checklist

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

Must have

18 years of age or older

Have T2D (defined as having an HbA1c equal to or greater than 6.5)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, 18 months post-intervention, 24 months post-intervention

Awards & highlights

FDSMEFBO Trial Summary

This trial will test whether the F-DSME diabetes education program is effective when delivered in a group setting in Marshallese Faith Based Organizations.

Who is the study for?

This trial is for Marshallese individuals aged 18 or older with Type 2 Diabetes (T2D), having an HbA1c of at least 6.5, and a family member willing to participate. It's not for those who've had diabetes education in the last five years, plan to move away, or have conditions like terminal illness that would prevent following the study protocol.Check my eligibility

What is being tested?

The study tests if Family Model Diabetes Self-Management Education (F-DSME) is effective when given in group sessions at Marshallese Faith Based Organizations. Previously successful in homes, this trial checks its impact in a new setting.See study design

What are the potential side effects?

Since this intervention involves education and support rather than medication, typical drug side effects are not expected. However, participants may experience stress or emotional discomfort during the learning process.

FDSMEFBO 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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My HbA1c level is 6.5 or higher, indicating I have type 2 diabetes.

FDSMEFBO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, 18 months post-intervention, 24 months post-intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, 18 months post-intervention, 24 months post-intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, immediate post-intervention, 6 months post-intervention, 12 months post-intervention, 18 months post-intervention, 24 months post-intervention for reporting.

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 Adjusted Mean HbA1c(%) From Baseline at various time points

FDSMEFBO Trial Design

2Treatment groups

Experimental Treatment

Group I: Wait ListExperimental Treatment1 Intervention

Group II: Family DSMESExperimental Treatment1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ArkansasLead Sponsor

486 Previous Clinical Trials

149,777 Total Patients Enrolled

National Institute on Minority Health and Health Disparities (NIMHD)NIH

383 Previous Clinical Trials

1,215,635 Total Patients Enrolled

Pearl McElfish, Phd, MDAPrincipal InvestigatorUniversity of Arkansas

Media Library

Family Model Diabetes Self-Management Education and Support Clinical Trial Eligibility Overview. Trial Name: NCT04256486 — N/A

Type 2 Diabetes Research Study Groups: Family DSMES, Wait List

Type 2 Diabetes Clinical Trial 2023: Family Model Diabetes Self-Management Education and Support Highlights & Side Effects. Trial Name: NCT04256486 — N/A

Family Model Diabetes Self-Management Education and Support 2023 Treatment Timeline for Medical Study. Trial Name: NCT04256486 — N/A

Frequently Asked Questions

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

How many participants are presently enrolled in this research program?

"Affirmative. The records on clinicaltrials.gov verify that this experiment, which was initially posted on April 21st 2022, is currently soliciting individuals for participation. A total of 576 participants are required from 1 medical facility."

Answered by AI

Is enrollment currently open for this research endeavor?

"Data from clinicaltrials.gov confirms that this study is currently enrolling participants, as the trial was first published on April 21st 2022 and edited for the last time four days later."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Family Model Diabetes Self-Management Education in Faith Based Organizations

2022. "Family Model Diabetes Self-Management Education in Faith Based Organizations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04256486.