Diabetes Self-Management Education for Diabetes

(FDSMEFBO Trial)

Recruiting at 1 trial location

Overseen By Betsy O'Connor, MA, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arkansas

Disqualifiers: Terminal illness, Severe mental illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate Post-intervention

321 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study's objective is to conduct a cluster randomized control study that evaluates the effectiveness of F-DSME (Family Model Diabetes Self-Management Education) when delivered in a group setting in Marshallese Faith Based Organizations (FBO). The F-DSME has shown to be effective when delivered in patients' homes, and the proposed research will allow us to determine the F-DSME's effectiveness in a FBO setting.

Who Is on the Research Team?

Pearl McElfish, Phd, MDA

Principal Investigator

University of Arkansas

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Self-reported Marshallese

Have at least one family member willing to take part

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

Exclusion Criteria

I am able to follow the study's requirements without major health or mental barriers.

I have received diabetes self-management education in the last 5 years.

Plans to move out of the geographic region

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Family Model Diabetes Self-Management Education in a group setting within Faith Based Organizations

Immediate Post-intervention

Follow-up

Participants are monitored for glycemic control and changes in HbA1c levels

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Family Model Diabetes Self-Management Education and Support

Trial Overview 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.

How Is the Trial Designed?

Group I: Wait List Experimental Treatment 1 Intervention

Group II: Family DSMES Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+