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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist people with type 2 diabetes who struggle with food insecurity by using community health workers (CHWs) to enhance the effectiveness of produce prescription programs (PRx). Participants will either receive support from a CHW, who helps overcome obstacles to using PRx, or participate in PRx without this additional support. The trial seeks Hispanic Medicaid-eligible individuals living in Hartford County with a current diagnosis of type 2 diabetes. As an unphased trial, this study offers a unique opportunity to contribute to research that could improve access to healthy food for those with type 2 diabetes.

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 prior data suggests that the community health worker strategy is safe for improving PRx uptake?

Research shows that community health workers (CHWs) are generally safe for people with type 2 diabetes. Studies have found that CHWs help patients manage their diabetes effectively without major safety issues. These strategies often lead to better health outcomes, such as improved blood sugar control, by offering personalized support and guidance.

No specific list of side effects has been linked to the CHW approach in the available studies, suggesting that the method is well-tolerated. The focus remains on helping people manage their health better through education and support, rather than introducing new medications or procedures.

Overall, the CHW approach appears to be a safe way to improve diabetes care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Community Health Worker (CHW) strategy for managing Type 2 diabetes because it offers a personalized approach that differs from traditional medication and lifestyle interventions. Unlike standard treatments that often focus on medication adherence and general lifestyle advice, the CHW strategy leverages trained community members to provide tailored support and help overcome individual barriers to care. This hands-on, community-based method aims to improve patient engagement and adherence to prescribed regimens, potentially leading to better health outcomes. By incorporating social support and practical assistance, this approach could address the emotional and logistical challenges faced by patients, which are often overlooked by conventional treatments.

What evidence suggests that the community health worker strategy is effective for improving PRx uptake in patients with type 2 diabetes?

Research shows that community health workers (CHWs) can significantly aid in managing type 2 diabetes. In this trial, one group of participants will receive personalized support from CHWs to overcome barriers and leverage facilitators for better diabetes management. Studies have found that patients working with CHWs improved their blood sugar levels, measured by HbA1c, from 8.6% to 7.8% in six months. Another study demonstrated that patients with CHW support managed their blood sugar better than those without, even during challenging times like the COVID-19 pandemic. Overall, involving CHWs in diabetes care has led to better blood sugar control and improved self-care skills. This suggests that CHWs can effectively support people with type 2 diabetes. ^{2 6 7 8 9}

Who Is on the Research Team?

Rafael Perez-Escamilla, MD

Principal Investigator

Yale School of Public Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12265813/

Evaluating the effectiveness of community health worker ... In previous systematic reviews, the effect of CHW interventions in type 2 diabetes included studies that provided short-term follow-up data.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3929361/

The Role of Community Health Workers in Diabetes Hemoglobin A1c (HbA1c) improved from 8.6% to 7.8% compared to no change in the control group at 6-month follow up. Self-management knowledge showed ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2211335524000603

Impact of community health workers on diabetes ... Patients with CHWs were better able to manage their A1C levels than patients without CHWs, both before and after the onset of the COVID-19 pandemic. •. CHWs can ...

4. thecommunityguide.org thecommunityguide.org/findings/diabetes-prevention-interventions-engaging-community-health-workers.html

Diabetes Prevention: Community Health Workers Overall, included studies showed the following: Interventions engaging community health workers improved participants' glycemic or blood sugar control (HbA1c, ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06401668

Impact of a Community Health Worker Strategy on Produce ... Produce prescription programs (PRx) are promising interventions for improving health outcomes for patients with both type 2 diabetes (T2D) and food ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9512562/

Community Health Workers as Trust Builders and Healers We evaluated whether a practice-integrated community health worker (CHW) intervention could encourage effective long-term self-management of type 2 diabetes ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7174477/

Integrating Community Health Workers into Safety-Net Primary ... Evidence shows community health workers (CHWs) can effectively deliver proven behavior-change strategies to prevent type 2 diabetes mellitus (diabetes)

8. bmjopen.bmj.com bmjopen.bmj.com/content/15/7/e096651

a systematic review and meta-analysis CHW interventions in type 2 diabetes showed statistically significant and clinically important reductions in HbA1c levels in people from minority ethnic groups ...

9. withpower.com withpower.com/trial/phase-diabetes-type-2-5-2024-8326e

Community Health Worker Strategy for Type 2 Diabetes The overall objective of this study is to test and evaluate a theory-informed, user-centered community health worker (CHW) implementation strategy to improve ...