Community Health Worker Strategy for Type 2 Diabetes

Overseen By Katherine LaMonaca, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Gestational diabetes, Incarceration, Non-consent, others

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

Compensation: Varies

Number of Visits: Unknown

116 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 seems focused on providing support and resources rather than changing your medication.

What data supports the effectiveness of the community health worker strategy for type 2 diabetes treatment?

Research shows that community health workers (CHWs) can help people with type 2 diabetes manage their condition better, especially in vulnerable groups. They are effective in encouraging long-term self-care and improving health behaviors related to diabetes. ^{1 2 3 4 5}

Is the Community Health Worker (CHW) strategy safe for humans?

The available research does not specifically address safety concerns related to the Community Health Worker (CHW) strategy, but patients generally have a positive perception of the program, suggesting it is well-received and may be safe. ^{1 6 7 8 9}

How is the community health worker strategy different from other treatments for type 2 diabetes?

The community health worker (CHW) strategy is unique because it involves trained individuals from the community who help patients manage their diabetes through education and support, especially targeting low-income and minority groups. Unlike traditional medical treatments, CHWs focus on teaching self-management skills and providing personalized support, making it a more accessible and culturally sensitive approach. ^{3 5 9 10 11}

What is the purpose of this trial?

Produce prescription programs (PRx) are promising interventions for improving health outcomes for patients with both type 2 diabetes (T2D) and food insecurity, but uptake has been suboptimal. There is a critical need for scalable, evidence-based implementation strategies for improving PRx uptake and optimizing the effectiveness and cost-effectiveness of these interventions. This study will co-design and pilot a community health worker (CHW) strategy and test the effectiveness of the strategy compared to PRx participants without a CHW. The overall objective of this study is to test and evaluate a theory-informed, user-centered community health worker (CHW) implementation strategy to improve uptake of a PRx, among Hispanic Medicaid-eligible patients with T2D in Connecticut (CT). CHWs will offer participants personalized support by overcoming barriers and leveraging facilitators to PRx uptake.

Research Team

Rafael Perez-Escamilla, MD

Principal Investigator

Yale School of Public Health

Eligibility Criteria

This trial is for Hispanic individuals with type 2 diabetes who are eligible for Medicaid in Connecticut. They should be experiencing food insecurity and have not yet taken part in a Produce Prescription (PRx) Program.

Inclusion Criteria

Identify as Hispanic

Be a current primary or specialty care patient at Hartford Hospital

Live in Hartford County

Exclusion Criteria

I have been diagnosed with gestational diabetes.

Individuals who are members of vulnerable populations, such as individuals who are incarcerated and individuals who are not able to consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pilot Study

A two-month pilot study with 10 participants to test the CHW strategy and PRx program

8 weeks

Regular visits as needed for pilot evaluation

Randomized Controlled Trial

Participants are randomized to receive PRx with or without CHW strategy to evaluate effectiveness on PRx uptake and health outcomes

6 months

Monthly visits for data collection and program engagement

Follow-up

Participants are monitored for safety and effectiveness after the trial

4 weeks

Treatment Details

Interventions

• Community health worker (CHW) strategy

Trial Overview The study is testing if having a Community Health Worker (CHW) to support participants can increase their involvement in the PRx Program, which aims to improve health outcomes by providing access to fresh produce.

Participant Groups

Group I: PRx with the CHW strategy Experimental Treatment 2 Interventions

Participants in this group will have CHWs to offer participants personalized support by overcoming barriers and leveraging facilitators to PRx uptake.

Group II: PRx without the CHW strategy Active Control 1 Intervention

Participants in this group will participate in the PRx without the use of CHWs

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Findings from Research

Community health workers (CHWs) have been shown to effectively reduce emergency care among low-income, ethnic minority patients with type 2 diabetes, highlighting their potential role in managing chronic conditions.

However, a secondary analysis of a randomized controlled trial indicated that CHWs did not significantly impact non-urgent, ambulatory healthcare utilization, suggesting that their effectiveness may be limited to emergency care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do community health workers affect non-urgent, ambulatory healthcare utilization among low-income, minority patients with diabetes? Chiu, RG., Xia, Y., Sharp, LK., et al.[2020]

The Home Health Parties (HHP) intervention effectively improved diabetes self-management among Hispanics in rural Washington by emphasizing family involvement and social support, as reported by 40 participants through qualitative interviews.

Key strategies included the role of trained community health workers (promotores) in fostering trust and cultural understanding, and the use of practical tools like cookbooks and monitoring devices to enhance participants' skills and confidence in managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"The Promotora Explained Everything": Participant Experiences During a Household-Level Diabetes Education Program. Shepherd-Banigan, M., Hohl, SD., Vaughan, C., et al.[2021]

The Peer-AID trial is evaluating a home-based intervention delivered by community health workers to help low-income individuals with poorly controlled type 2 diabetes, with a focus on improving A1c levels over 12 months.

The study successfully enrolled 287 diverse participants from disadvantaged backgrounds, highlighting the potential for community-based programs to address diabetes management in vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer Support for Achieving Independence in Diabetes (Peer-AID): design, methods and baseline characteristics of a randomized controlled trial of community health worker assisted diabetes self-management support. Nelson, K., Drain, N., Robinson, J., et al.[2022]

A community health worker (CHW) intervention significantly improved long-term self-management of type 2 diabetes in patients facing social disadvantages, with 33% achieving self-care generativity after engaging with the program.

Patients who reached self-care generativity showed greater declines in hemoglobin A1c (HbA1c) levels over time, averaging 8.5% compared to 8.8% and 9.0% in other groups, and had lower rates of emergency department and hospital visits, indicating improved health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community Health Workers as Trust Builders and Healers: A Cohort Study in Primary Care. Ferrer, RL., Schlenker, CG., Cruz, I., et al.[2022]

The community health worker (CHW) model shows promise in diabetes management, with eight studies reviewed highlighting various roles such as educator and advocate, but the effectiveness and implementation details vary widely across programs.

There is a lack of consensus on the specific roles and training of CHWs in diabetes programs, indicating a need for more rigorous research to optimize their integration into chronic disease management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applying the community health worker model to diabetes management: using mixed methods to assess implementation and effectiveness. Cherrington, A., Ayala, GX., Amick, H., et al.[2011]

The community health worker (CHW) program significantly improved patient satisfaction with accessing health services and community resources among 13 patients with type 2 diabetes.

Patients viewed the CHW program positively, indicating it could effectively address their health and social needs in safety net healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' Perspectives on the Feasibility, Acceptability, and Impact of a Community Health Worker Program: A Qualitative Study. Chang, W., Oo, M., Rojas, A., et al.[2021]

The diabetes education program for community health workers led to significant improvements in patients' lipid profiles, with reductions in total cholesterol and triglycerides, indicating potential benefits beyond just blood sugar control.

While both the intervention and control groups showed a decrease in HbA1c levels, the changes were not statistically different between the two groups, suggesting that the education program did not have a unique impact on blood sugar levels compared to standard health education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of an education course delivered to community health workers in diabetes control: A randomized clinical trial. de Souza, CF., Dalzochio, MB., Zucatti, ATN., et al.[2022]

Community health workers (CHWs) played a crucial role in diabetes self-management by providing encouragement and motivation during 1859 individual patient contacts, which helped patients incorporate diabetes management into their daily lives.

Patients reported that the personal connection and support from CHWs were distinct from that provided by family or healthcare teams, highlighting the importance of integrating CHWs into standard diabetes care practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teaching how, not what: the contributions of community health workers to diabetes self-management. Davis, KL., O'Toole, ML., Brownson, CA., et al.[2018]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Do community health workers affect non-urgent, ambulatory healthcare utilization among low-income, minority patients with diabetes? [2020]

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

"The Promotora Explained Everything": Participant Experiences During a Household-Level Diabetes Education Program. [2021]

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

Peer Support for Achieving Independence in Diabetes (Peer-AID): design, methods and baseline characteristics of a randomized controlled trial of community health worker assisted diabetes self-management support. [2022]

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

Community Health Workers as Trust Builders and Healers: A Cohort Study in Primary Care. [2022]

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

Applying the community health worker model to diabetes management: using mixed methods to assess implementation and effectiveness. [2011]

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

Patients' Perspectives on the Feasibility, Acceptability, and Impact of a Community Health Worker Program: A Qualitative Study. [2021]

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

Efficacy of an education course delivered to community health workers in diabetes control: A randomized clinical trial. [2022]

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

Community Health Workers in Diabetes Prevention and Management in Developing Countries. [2022]

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

The role of community health workers in diabetes: update on current literature. [2022]

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

Teaching how, not what: the contributions of community health workers to diabetes self-management. [2018]

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

Integrating Community Health Workers into Safety-Net Primary Care for Diabetes Prevention: Qualitative Analysis of Clinicians' Perspectives. [2022]