Diabetes Education for Type 2 Diabetes

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Pearl McElfish, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Arkansas

Disqualifiers: Severe mental illness, terminal illness, others

No Placebo Group

Trial Summary

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.

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 4 5}

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. ^{2 3 4 6 7}

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. ^{2 3 4 8 9}

Eligibility Criteria

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.

I am 18 years old or older.

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

Trial Timeline

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)

Treatment Details

Interventions

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

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.

Participant Groups

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

UAMS Community Health and Research Springdale, AR

UAMS Institute for Community Health Innovation Springdale, AR

Who Is Running the Clinical Trial?

University of Arkansas Lead Sponsor

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

References

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] Diabetes self-management education and support (DSMES) is an effective approach for improving diabetes self-care behaviors to achieve improved glycemic management and other health outcomes. Engaging family members may improve outcomes, both for the person with diabetes (PWD) and for the family members. However, family models of DSMES have been inconsistently defined and delivered. We operationalize Family-DSMES to be generalizable and replicable, detail our protocol for a comparative effectiveness trial comparing Standard-DSMES with Family-DSMES on outcomes for PWDs and family members, and detail our mixed-methods implementation evaluation plan.

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

Effects of a family diabetes self-management education intervention on the patients' supporters. [2023] Diabetes self-management education (DSME) programs that engage the families of patients with diabetes have shown to be effective in improving diabetes-related outcomes of the patients. The health effects of these "family models" of DSME on participating family members are rarely studied. Opportunity exists for the participating family members to benefit from the healthy lifestyle recommendations offered through such programs.

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

Towards a better understanding of self-management interventions in type 2 diabetes: A concept analysis. [2022] Diabetes self-management educational (DSME) interventions can vary considerably, and it is unclear what is the operational conceptualization of the ideal delivery to individuals with type 2 diabetes (T2D).

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] Diabetes self-management education (DSME) can be delivered in many forms. Group based DSME is widespread due to being a cheaper method and the added advantages of having patient meet and discuss with each other. assess effects of group-based DSME compared to routine treatment on clinical, lifestyle and psychosocial outcomes in type-2 diabetes patients.

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] IN BRIEF Diabetes self-management education and support (DSMES) provides the foundation to help people with diabetes (PWD) navigate the numerous self-management decisions and complex care activities they face daily and has been shown to improve outcomes. Without DSMES, PWD often lack the skills and knowledge necessary to handle the demands of managing this chronic disease. Understanding self-management behaviors and responses to DSMES is essential for improving DSMES processes and diabetes outcomes. This article provides the most recent findings from questions regarding self-management behaviors and DSMES practices obtained through the National Diabetes Education Program National Diabetes Survey. Insights and gaps in self-management behaviors and DSMES delivery are examined to identify challenges and offer opportunities for improvement.

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

Diabetes education: looking through the kaleidoscope. [2013] Diabetes self-management education (DSME) is a critical element of care for all people with diabetes and those at risk for developing diabetes. In spite of growing evidence of the value of DSME in reducing hospitalization costs, improvement in glucose, weight and medication adherence, DSME remains an underutilized insurance benefit and access to qualified diabetes educators is problematic.

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

Self-management Education in Type 2 Diabetes in Primary Care. [2021] Diabetes self-management education (DSME) is defined as a systematic intervention involving active participation of the individual in self-monitoring of health parameters and/or decision making using knowledge and skills. The goal of DSME is to create opportunities for people with diabetes to be informed and motivated to continuously participate in effective methods and methods of self-monitoring of diabetes.

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

Quick guide to type 2 diabetes self-management education: creating an interdisciplinary diabetes management team. [2020] Type 2 diabetes is a chronic disease that requires several daily self-management decisions and complex care activities. Clinical management of diabetes and teaching patients diabetes self-management skills are necessary for optimal type 2 diabetes control. Diabetes self-management education (DSME) and support require time and resources. While there is a plethora of education material for health care professionals to use, very few guides compile the information in a practical way to relay the information to the patient. This quick guide to DSME has been developed to give physicians and their staff the tools to teach basic type 2 diabetes self-management skills in three 15-minute clinic visits.

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

Diabetes knowledge and glycemic control among Chinese people with type 2 diabetes. [2022] Diabetes self-management education (DSME) is a key component of effective glycemic control and an important part of clinical diabetes management. The effects of DSME in China have not been investigated.