Diabetes Education for Type 2 Diabetes

Recruiting at 1 trial location

Overseen By Brett Rowland, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arkansas

Disqualifiers: Severe mental illness, terminal illness, others

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

Compensation: Varies

Number of Visits: 4

288 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Health disparities in the Republic of the Marshall Islands are striking, with extremely high rates of type 2 diabetes. Documented prevalence of type 2 diabetes in the Marshall Islands ranges from 20%-50%.This is significantly higher than the global (8.5%) and United States (11%) prevalence. Diabetes doubles the risk of heart disease; is the leading cause of kidney failure, lower limb amputation, and acquired blindness; and reduces life expectancy by as much as 15 years. Diabetes self-management education and support is critical for persons with diabetes. This study aims to conduct a cluster-randomized controlled trial using a wait-list control to evaluate the effectiveness of family model diabetes self-management education and support when delivered in faith-based organizations (i.e., churches) in Marshallese by trained community health workers. The study will be conducted with up to 288 participants with type 2 diabetes and up to 288 of their family members. The primary study outcome will be glycemic control as measured by HbA1c. Secondary biometric measures include: fasting glucose, weight, body mass index, and blood pressure. Survey data will be collected pre-intervention, immediately post-intervention, four months post-intervention, and 12 months post-intervention for the intervention arm of the study. The control arm of the study will have two pre-intervention data collections before beginning the intervention. Data will then be collected from the control group immediately post-intervention, four months post-intervention, and 12 months post intervention.

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 diabetes education and support, so it's likely you can continue your current treatment, but you should confirm with the trial organizers.

Is the Family Model Diabetes Self-Management Education and Support safe for humans?

The available research does not provide specific safety data for the Family Model Diabetes Self-Management Education and Support, but these programs generally focus on education and lifestyle changes, which are typically safe for participants. ^{1 2 3 4 5}

How is the Family Model DSME treatment different from other treatments for type 2 diabetes?

The Family Model DSME treatment is unique because it involves the patient's family in the diabetes education process, which can improve outcomes for both the patient and their family members by promoting healthy lifestyle changes together. ^{1 2 3 6 7}

What data supports the effectiveness of the treatment Family Model Diabetes Self-Management Education and Support for Type 2 Diabetes?

Research shows that diabetes self-management education and support (DSMES) programs, especially those involving family members, can improve diabetes-related outcomes for patients. Engaging family members in these programs may enhance the health benefits for both patients and their families. ^{1 2 3 8 9}

Who Is on the Research Team?

Pearl McElfish, PhD

Principal Investigator

University of Arkansas

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have type 2 diabetes with an HbA1c of 6.5% or higher.

You are of Marshallese descent.

Have at least one family member willing to take part in the study

Exclusion Criteria

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.

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

Pre-Intervention

Survey data collected pre-intervention for both intervention and control groups

2 weeks

1 visit (in-person)

Intervention

Family model diabetes self-management education and support delivered in faith-based organizations

12 weeks

Weekly sessions (in-person)

Post-Intervention Follow-up

Survey data collected immediately post-intervention, 4 months post-intervention, and 12 months post-intervention

12 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Family Model Diabetes Self-Management Education and Support
• Family Model Diabetes Self-Management Education and Support (Wait-list)

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Family model diabetes self-management education and support

Group II: Wait-list Control Active Control 1 Intervention

Family model diabetes self-management education and support

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

The study aims to compare the effectiveness of Family-DSMES, which involves family members in diabetes self-management education, against Standard-DSMES for individuals with type 2 diabetes, involving participants aged 18 and older with a hemoglobin A1c of 7.0% or higher.

Data will be collected at multiple time points (baseline, post-intervention, and at 6, 12, and 18 months) to assess various outcomes, including the primary outcome of hemoglobin A1c levels, and to evaluate the impact on both the person with diabetes and their family members.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness-implementation trial comparing a family model of diabetes self-management education and support with a standard model. Mayberry, LS., Felix, HC., Hudson, J., et al.[2023]

In a study involving Marshallese adults with Type 2 diabetes, family members who attended diabetes self-management education (DSME) sessions did not show significant improvements in A1c levels, BMI, food consumption, or physical activity compared to those who did not attend, indicating low engagement and effectiveness of the program for families.

The only significant predictor of having a normal A1c level after 12 months was a reduction in BMI, suggesting that while family DSME may not have directly benefited family members, weight management could be crucial for diabetes prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a family diabetes self-management education intervention on the patients' supporters. Felix, HC., Narcisse, MR., Long, CR., et al.[2023]

The study identified five key attributes of effective diabetes self-management education (DSME) interventions for individuals with type 2 diabetes, categorized into skills-related (decision making, problem solving, taking action) and information-related attributes (patient-provider interaction, resource utilization).

By clarifying these attributes, the research provides a measurable framework for designing and implementing DSME interventions, which can enhance the effectiveness of diabetes management programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Towards a better understanding of self-management interventions in type 2 diabetes: A concept analysis. Othman, MM., Khudadad, H., Dughmosh, R., et al.[2022]

Group-based diabetes self-management education (DSME) significantly reduces HbA1c levels in type 2 diabetes patients, with reductions observed at 6 months (0.44%), 12 months (0.46%), and 2 years (0.87%), indicating effective long-term management of blood sugar levels.

Participants in group-based DSME also showed significant improvements in diabetes knowledge and self-management skills, with effect sizes indicating strong benefits at 6 months and beyond, highlighting the educational advantages of this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group based diabetes self-management education compared to routine treatment for people with type 2 diabetes mellitus. A systematic review with meta-analysis. Steinsbekk, A., Rygg, LØ., Lisulo, M., et al.[2022]

Diabetes self-management education and support (DSMES) is crucial for people with diabetes, as it equips them with the necessary skills and knowledge to manage their condition effectively, leading to improved health outcomes.

The article highlights recent findings from the National Diabetes Education Program National Diabetes Survey, which identifies gaps in self-management behaviors and DSMES delivery, suggesting areas for improvement to enhance diabetes care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insights From the National Diabetes Education Program National Diabetes Survey: Opportunities for Diabetes Self-Management Education and Support. Piccinino, LJ., Devchand, R., Gallivan, J., et al.[2020]

Diabetes self-management education (DSME) is essential for improving health outcomes in people with diabetes, yet it remains underutilized despite evidence showing it can reduce hospitalization costs and improve glucose control, weight management, and medication adherence.

The future of DSME faces significant challenges in the current healthcare system, particularly in integrating diabetes education with clinical care, highlighting the need for new strategies and guidelines to meet the growing demand for diabetes educators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes education: looking through the kaleidoscope. Tomky, D.[2013]

A study involving 120 primary care physicians found that more than half provided inadequate quality of diabetes self-management education (DSME) across various areas, indicating a need for improvement in training.

The highest scores were in the 'drug intake' domain, while lower scores in 'problem-solving' and 'being active' suggest that physicians may not be effectively equipping patients with the skills needed for comprehensive diabetes self-management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management Education in Type 2 Diabetes in Primary Care. Korzh, O.[2021]

A new quick guide for Diabetes Self-Management Education (DSME) has been created to help healthcare providers teach essential self-management skills for type 2 diabetes during three 15-minute clinic visits.

This guide aims to streamline the education process, making it easier for healthcare professionals to effectively communicate important diabetes management strategies to patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quick guide to type 2 diabetes self-management education: creating an interdisciplinary diabetes management team. Chester, B., Stanely, WG., Geetha, T.[2020]

In a study of 100 patients with type 2 diabetes in Shanghai, the average diabetes knowledge score was 22.1 out of 30, indicating a moderate level of understanding among participants.

There was no significant difference in overall diabetes knowledge between patients with good glycemic control (HbA1c <7%) and those with suboptimal control (HbA1c ≥7%), suggesting that knowledge alone may not directly influence glycemic outcomes, although specific areas like sick day management showed variability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes knowledge and glycemic control among Chinese people with type 2 diabetes. He, X., Wharrad, HJ.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Effectiveness-implementation trial comparing a family model of diabetes self-management education and support with a standard model. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of a family diabetes self-management education intervention on the patients' supporters. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Towards a better understanding of self-management interventions in type 2 diabetes: A concept analysis. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Group based diabetes self-management education compared to routine treatment for people with type 2 diabetes mellitus. A systematic review with meta-analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Insights From the National Diabetes Education Program National Diabetes Survey: Opportunities for Diabetes Self-Management Education and Support. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Diabetes education: looking through the kaleidoscope. [2013]

7. Bulgaria pubmed.ncbi.nlm.nih.gov

Self-management Education in Type 2 Diabetes in Primary Care. [2021]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Quick guide to type 2 diabetes self-management education: creating an interdisciplinary diabetes management team. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Diabetes knowledge and glycemic control among Chinese people with type 2 diabetes. [2022]