Family vs Standard Diabetes Education for Type 2 Diabetes

Overseen By Brett Rowland, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Arkansas

Disqualifiers: Recent DSME, Protocol adherence issues

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

Compensation: Varies

Number of Visits: 16

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two approaches to diabetes education for individuals with type 2 diabetes. One group will attend sessions with a family member to learn about managing diabetes together, while the other group will attend sessions independently. The researchers aim to determine if involving family members in education impacts diabetes management. Individuals with long-standing type 2 diabetes who haven't recently received formal diabetes education might be suitable for this trial. As an unphased trial, this study provides a unique opportunity to explore new educational strategies that could enhance diabetes management.

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 to focus on diabetes education rather than medication changes.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that diabetes self-management education and support (DSMES) is generally safe for people with type 2 diabetes. DSMES has effectively helped manage diabetes for many years by teaching patients to control their blood sugar levels through lifestyle changes. Studies have shown that DSMES can lower A1C levels, which measure blood sugar, without causing significant side effects.

For safety, DSMES includes educational sessions led by certified diabetes educators. These sessions focus on setting goals and making healthy lifestyle changes. No serious side effects or safety issues have been reported from these educational programs. Therefore, both Family-DSME and Standard-DSME are expected to be safe and well-tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these diabetes education approaches because they both aim to boost self-management in people with Type 2 Diabetes (T2D), but the Family Diabetes Self-Management Education and Support (Family-DSME) program takes it a step further by involving family members in the process. Unlike standard programs that focus solely on the individual, Family-DSME includes family motivational interviewing, goal-setting, and education on supportive behaviors, which could create a more supportive home environment for the patient. This approach might enhance the patient's ability to manage their condition effectively, potentially leading to better health outcomes. Researchers hope to find out if involving family members in diabetes education makes a significant difference in managing T2D compared to the traditional, patient-only education model.

What evidence suggests that this trial's treatments could be effective for type 2 diabetes?

This trial compares two approaches to diabetes education: Family Diabetes Self-Management Education and Support (Family-DSME) and Standard Diabetes Self-Management Education and Support (Standard-DSME). Research has shown that education programs for managing type 2 diabetes are effective. When family members participate, as in the Family-DSME arm of this trial, it can be even more beneficial. Studies suggest that family involvement boosts support and understanding, leading to better diabetes control. These family-focused programs succeed by considering both the patient and family interactions, which are crucial for long-term success. Overall, including family in diabetes education can increase motivation and support, potentially leading to better outcomes for those with type 2 diabetes. ^{5 6 7 8 9}

Who Is on the Research Team?

Pearl McElfish, PhD

Principal Investigator

UAMS

Are You a Good Fit for This Trial?

This trial is for adults over 18 with type 2 diabetes (HbA1c ≥ 7.0) who have not had formal diabetes education in the past three years and have a family member willing to participate. It's not suitable for those unable to follow the study protocol due to other conditions.

Inclusion Criteria

Have a family member willing to take part in the study

My diabetes is not well-controlled (HbA1c ≥ 7.0).

Exclusion Criteria

I have completed a diabetes self-management education program in the last 3 years.

Have a condition that makes it unlikely for them to be able to follow the protocol

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive DSMES sessions over 10 weeks, with family members participating in the Family-DSMES arm

10 weeks

10 visits (in-person)

Follow-up

Participants are monitored for changes in diabetes management and health outcomes post-intervention

18 months

Data collection at immediate post-intervention, 6, 12, and 18 months

What Are the Treatments Tested in This Trial?

Interventions

• Family Diabetes Self-Management Education and Support
• Standard Diabetes Self-Management Education and Support

Trial Overview

The trial compares two types of diabetes education: one where patients alone receive standard self-management support, and another where a patient's family member also gets involved in learning sessions. Each group will include 300 patients, randomly assigned.

How Is the Trial Designed?

Group I: Family-DSME Experimental Treatment 1 Intervention

Approach * Family motivational interviewing techniques * Family goal setting * Understanding supportive and nonsupportive family behaviors * Family behavioral changes Mode of Delivery * Group sessions delivered by a certified diabetes educator (CDE) to patients and their family members Dosage * 10 hours delivered in one-hour sessions over 10 weeks Participants * 300 patients with T2D and 300 family members (family members will take part in educational sessions and data collection)

Group II: Standard-DSME Active Control 1 Intervention

Approach * Individual motivational interviewing techniques * Individual goal setting * Individual behavioral changes Mode of Delivery * Group sessions delivered by a CDE to patients Dosage * 10 hours delivered in one-hour sessions over 10 weeks Participants * 300 patients with T2D (family members will take part in data collection but not educational sessions)

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

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]

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]

Intensive glycaemic management through diabetes self-management education programs has been shown to improve health outcomes for both type 1 and type 2 diabetes patients, enhancing their knowledge, skills, and motivation.

These programs are effective and cost-efficient, but they need to be tailored to specific populations considering various factors like type of diabetes and cultural background to maximize access and uptake globally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes structured self-management education programmes: a narrative review and current innovations. Chatterjee, S., Davies, MJ., Heller, S., et al.[2018]

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]

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