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

1200 Participants Needed

Trial Summary

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.

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

Research shows that diabetes self-management education involving family support can improve health behaviors, psychological well-being, and glycemic control in patients with type 2 diabetes. Family involvement in diabetes care has been found to enhance self-management behaviors and health outcomes. ^{1 2 3 4 5}

Is Family vs Standard Diabetes Education safe for humans?

The research does not specifically address safety concerns, but diabetes self-management education programs, including those involving family support, are generally focused on improving health behaviors and outcomes, suggesting they are safe for participants. ^{1 2 3 6 7}

How does the Family Diabetes Self-Management Education and Support treatment differ from other treatments for type 2 diabetes?

This treatment is unique because it involves family members in the diabetes self-management education process, which has been shown to improve patients' health behaviors, psychological well-being, and glycemic control by providing additional support and motivation. ^{1 6 8 9 10}

What is the purpose of this trial?

The investigators will conduct a fully-powered, comparative effectiveness randomized controlled trial that includes up to 600 patients with type 2 diabetes (T2D) and 600 of their family members. Patients with T2D will be randomly assigned to either the Family-DSMES arm or the Standard-DSMES arm, with 300 patients in each arm. In the Family-DSMES arm, one of each patient's family members will take part in the educational sessions (family members defined below). Baseline and follow-up data (immediate post-intervention, 6 months post-intervention, and 12 months post-intervention) will be collected from patients and family members in both study arms. In the Standard-DSMES arm, data will be collected from family members, but they will not participate in educational sessions. In both arms, the investigators will obtain a medical records release to abstract outcomes at 18 months post-intervention.

Research Team

Pearl McElfish, PhD

Principal Investigator

UAMS

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

A Systematic Review: Family Support Integrated with Diabetes Self-Management among Uncontrolled Type II Diabetes Mellitus Patients. [2023]

2. 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]

3. India pubmed.ncbi.nlm.nih.gov

The comparison of self-management group education and the standard care for patients with type 2 diabetes mellitus: An updated systematic review and meta-analysis. [2022]

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

Integrating Undergraduate Patient Partners into Diabetes self-management education: Evaluating a free clinic pilot program for the Underserved. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

To Adapt or Not to Adapt: The Association between Implementation Fidelity and the Effectiveness of Diabetes Self-Management Education. [2021]

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

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

7. Ireland pubmed.ncbi.nlm.nih.gov

Educational interventions aiming at improving adherence to treatment recommendations in type 2 diabetes: A sub-analysis of a systematic review of randomised controlled trials. [2018]

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

Using accreditation standards as a framework to evaluate and improve a community-based diabetes self-management education program. [2022]

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

Diabetes structured self-management education programmes: a narrative review and current innovations. [2018]

10. England pubmed.ncbi.nlm.nih.gov

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