Family-Focused Diabetes Management for Type 2 Diabetes

Overseen By Sandra Solove, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Pregnancy, Terminal condition, Cognitive impairment

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

Compensation: Varies

Number of Visits: 10

Duration: 12 weeks

208 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Family dyad diabetes intervention for Type 2 Diabetes?

Research shows that involving family in diabetes self-management education (DSME) can improve self-care behaviors, like glucose monitoring and doctor visits, for people with Type 2 Diabetes. Family-focused DSME has been effective in enhancing diabetes-related outcomes for patients. ^{1 2 3 4 5}

Is the Family-Focused Diabetes Management for Type 2 Diabetes treatment safe for humans?

The available research on family-focused diabetes self-management education (DSME) programs does not specifically address safety concerns, but these programs generally focus on improving lifestyle and self-care behaviors, which are typically safe and beneficial for participants. ^{2 3 4 5 6}

How is the Family Dyad Diabetes Self-Management Intervention treatment different from other treatments for type 2 diabetes?

This treatment is unique because it involves both the person with diabetes and their family members, focusing on improving self-care behaviors and diabetes management through family support, which can lead to better health outcomes for both the patient and their family. ^{1 2 3 5 6}

What is the purpose of this trial?

A family dyad-focused diabetes self-management for African American adults with type 2 diabetes is a randomized controlled trial (RCT) that aims to test the feasibility, acceptability, and efficacy of a family-dyad focused intervention on glycemic control (hemoglobin A1c) and health-related quality of life (HRQOL) in African American adults with type 2 diabetes (T2D).

Eligibility Criteria

African American adults over 40 with type 2 diabetes and a family member (spouse, adult child, or sibling) who live together can join. Both must speak English and be able to walk. The patient needs an A1c > 7.5% and diagnosed for at least six months. Those with cognitive impairments, advanced conditions, or unclear diabetes diagnosis are excluded.

Inclusion Criteria

You are African American and have type 2 diabetes.

Family members being a spouse, adult child, or sibling

I have type 2 diabetes and can walk.

Exclusion Criteria

I have type 2 diabetes but no definitive proof of it.

You have type 2 diabetes and your family members cannot make decisions for you.

You have type 2 diabetes and a family member who is pregnant or has a serious illness.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 10 virtual group sessions on diabetes self-management and family support over 12 weeks

12 weeks

10 virtual sessions

Post-intervention Assessment

Participants are assessed immediately after the intervention for changes in health-related quality of life and diabetes control

1 week

Follow-up

Participants are monitored for changes in diabetes control and blood pressure six months after the intervention

6 months

Treatment Details

Interventions

• Family dyad diabetes intervention

Trial Overview The trial is testing how well a program designed for African American adults with type 2 diabetes and their family members works in improving blood sugar control and quality of life. It's a randomized controlled study comparing the new intervention against usual care.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Patient-family member dyads in the family dyad intervention arm will receive 1) 10 sessions (8 weekly and 2 biweekly) over 12 weeks of family-dyad-focused, virtual group sessions on diabetes self-management and family support; 2) family dyad-focused support component in each group session; and 3) individual family feedback telephone sessions.

Group II: Control Active Control 1 Intervention

All control participants will receive usual care from their primary healthcare provider. A condensed family dyad diabetes intervention will be delivered to the control participants by the end of the study.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

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]

A study involving 211 Marshallese adults with type 2 diabetes found that a Family Diabetes Self-Management Education (DSME) intervention led to greater improvements in glucose monitoring and doctor visits compared to a Standard DSME intervention.

Participants in the Family DSME group showed a more significant increase in glucose monitoring engagement over 12 months, suggesting that family involvement in diabetes education can enhance self-care behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Family Diabetes Self-management Education on Self-care Behaviors of Marshallese Adults with Type 2 Diabetes. Felix, HC., Narcisse, MR., Long, CR., et al.[2020]

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]

Participation in a 6-week Diabetes Self-Management Education (DSME) program led to a significant reduction in hemoglobin A1c (HgbA1c) levels by 1.6% in overweight/obese patients, indicating improved glycemic control.

While BMI did not change significantly, participants showed marked improvements in diabetes knowledge and confidence, suggesting that DSME enhances self-management skills in community health center patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Diabetes Self-Management Education in Community Health. Brown, K., Lee, LT., Selleck, C.[2020]

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. 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

The Effect of Family Diabetes Self-management Education on Self-care Behaviors of Marshallese Adults with Type 2 Diabetes. [2020]

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

Effectiveness of Diabetes Self-Management Education in Community Health. [2020]

6. England pubmed.ncbi.nlm.nih.gov

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