Diabetes Self-Management Education for Diabetes

(FDSMEFBO Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a diabetes education program taught in a group setting at Marshallese Faith-Based Organizations. The program, Family Model Diabetes Self-Management Education and Support (F-DSMES), has already shown success when conducted at home. Participants will either join the group sessions or be placed on a waitlist to compare outcomes. Suitable candidates are Marshallese adults with type 2 diabetes who have a family member willing to participate. This trial may be appropriate if living with T2D affects daily life and a supportive family member is available to join. As an unphased trial, this study offers the opportunity to contribute to valuable research that could enhance diabetes education for the Marshallese community.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on education rather than medication changes.

What prior data suggests that the Family Model Diabetes Self-Management Education and Support is safe?

Research has shown that the Family Model Diabetes Self-Management Education and Support (F-DSME) is generally safe for people. This family-focused approach to diabetes education helps individuals manage their condition effectively. No reports of serious side effects suggest that participants tolerate it well. This model has been successfully used at home, and researchers are now testing its effectiveness in group settings. The trial phase is "Not Applicable," indicating it isn't testing a new drug or treatment but rather focusing on education, which reduces the likelihood of harm. Overall, F-DSME appears to be a safe option for those seeking better diabetes management. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Family Model Diabetes Self-Management Education and Support (DSMES) because it takes a unique approach by involving family members in the management of diabetes. Unlike traditional diabetes treatments that focus on medication or individual patient education, this method emphasizes a supportive network, potentially improving adherence to lifestyle changes and medication. By engaging family members, it fosters a collaborative environment, which can lead to better health outcomes and empower patients in managing their diabetes more effectively. This approach could be a game-changer, providing a more holistic solution to diabetes management that goes beyond just the individual.

What evidence suggests that Family Model DSME is effective for diabetes management?

Research has shown that Family Model Diabetes Self-Management Education and Support (F-DSME), which participants in this trial may receive, helps people manage type 2 diabetes effectively. Studies have found that F-DSME reduces health problems by involving family members in the learning process. This method has proven effective at home, leading to better health for both patients and their families. This trial will compare the effectiveness of F-DSME in group settings at faith-based organizations with a waitlist control group. Early results suggest that this family-focused approach can improve diabetes management by providing support in a community setting. ^{2 5 6 7 8}

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36096282/

Effectiveness-implementation trial comparing a family model ... A comparative effectiveness trial comparing Standard-DSMES with Family-DSMES on outcomes for PWDs and family members, and detail our mixed-methods ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39584211/

Effectiveness of A Culturally Adapted Family Model ... - PubMed Introduction: Diabetes self-management education and support (DSMES) is effective for reducing health complications among people with type 2 diabetes (PWD).

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04334109

Comparative Effectiveness of Family DSMES and Standard ... Family Diabetes Self-Management Education and Support demonstrates the effectiveness of family-centered models of DSME that explicitly address diabetes self- ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S155171442400288X

Family model diabetes self-management education and ... This study will provide new and innovative information on the effectiveness of Family DSMES delivered in a group setting by CHWs in FBOs in the RMI.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04256486

Study Details | NCT04256486 | Family Model Diabetes Self ... 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7815654/

Family model diabetes self-management education and ... This manuscript describes the methods used to test the feasibility of delivering a culturally adapted family model of diabetes self-management education and ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2451865422001247

Study protocol for family model diabetes self-management ... The F-DSMES intervention consists of ten h of diabetes education delivered by CHWs over eight to ten weeks. Data will be collected from the intervention arm at ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8129774/

Effectiveness of diabetes self-management education (DSME ... Based on 15 articles, diabetes self-management education intervention provides significant effectiveness to lifestyle changes and the self-care of T2DM ...