MTM + CHW Support for Type 2 Diabetes

(ENRxICH Trial)

Overseen By Martha Maurer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Must be taking: Diabetes medications

Disqualifiers: Caregiver decision maker, others

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

Compensation: Varies

Number of Visits: 5

Duration: 6 months

376 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best ways to help adults with type 2 diabetes manage their condition more effectively. The study aims to determine which type of support—either from a pharmacist for Medication Therapy Management (MTM), from a Community Health Worker (CHW) for addressing life challenges, or both—can enhance diabetes self-management. Participants will be randomly assigned to one of four groups: usual care, pharmacist support, CHW support, or both supports combined. The trial seeks adults with type 2 diabetes who are taking diabetes medication and have difficulty managing their blood sugar levels. As an unphased trial, it offers participants the chance to contribute to innovative diabetes care strategies.

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 likely that you will continue your current diabetes medications, as the study aims to improve medication management.

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

Research has shown that Medication Therapy Management (MTM) is generally safe for people with diabetes. One study found that patients using MTM services had better control of their blood sugar levels. Another review indicated that MTM can help lower healthcare costs and improve medication use. However, it also revealed that many patients had medication issues needing attention.

Studies suggest that Community Health Worker (CHW) support is safe and well-received. CHWs have effectively helped people manage type 2 diabetes by improving blood sugar levels and lifestyle habits. This support focuses on education and guidance, ensuring safety.

Combining MTM with CHW support also appears safe. Studies on this combination show improvements in managing medications and making lifestyle changes. While these findings are positive, each person’s experience can differ. Participants should discuss any concerns with their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative support methods for managing Type 2 diabetes. Unlike standard treatments that focus primarily on medication management and lifestyle changes, this trial investigates the impact of Community Health Worker (CHW) support and Medication Therapy Management (MTM) on patient outcomes. CHWs provide personalized, community-based support, helping patients navigate healthcare systems and adhere to treatment plans. MTM offers a systematic approach to optimizing medication use and improving therapeutic outcomes. The combination of CHW and MTM might lead to more effective, personalized care by addressing both medical and social aspects of diabetes management.

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

Research has shown that Medication Therapy Management (MTM), a treatment in this trial, can significantly assist people with type 2 diabetes. Studies have found that MTM helps patients adhere to their medication plans, leading to better health and fewer hospital visits. Support from Community Health Workers (CHWs), another treatment option in this trial, also shows promise. It helps individuals manage their blood sugar and control diabetes, especially in areas with high diabetes rates. This trial will test the combination of MTM with CHW support, which may offer additional benefits, such as lowering blood sugar and enhancing overall well-being. This combination could be particularly effective for managing diabetes. ^{6 7 8 9 10}

Who Is on the Research Team?

Michelle Chui, PharmD, PhD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for Black and Hispanic adults aged 18-90 with type 2 diabetes, who speak English or Spanish. They must live in the study area, have a phone, take diabetes medication from the study pharmacy, and have an HbA1c of at least 8%. They can't join if they've had similar medicine management support recently or are in another program.

Inclusion Criteria

I am 18-90 years old, identify as Black or Hispanic, and have type 2 diabetes. I can speak or read English or Spanish.

HbA1c ≥ 8% based on point of care test

Willing to attend all orientation/training sessions

Exclusion Criteria

Participating in another lifestyle, or medication adherence program

I have a caregiver who makes key decisions about my health care.

Participated in standard MTM/MTM-related intervention in the last 6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of four interventions: usual care, Medication Therapy Management (MTM), Community Health Worker (CHW) support, or both MTM and CHW support for 6 months

6 months

Minimum of 5 visits with a pharmacist for MTM, multiple interactions with CHW

Follow-up

Participants are monitored for changes in medication adherence and HbA1c levels

6 months

Long-term follow-up

Participants' medication adherence and HbA1c levels are assessed at 12 months

6 months

What Are the Treatments Tested in This Trial?

Interventions

• CHW
• MTM

Trial Overview The study tests four approaches to improve diabetes self-management: usual care; added pharmacist support for medicine management; help from a Community Health Worker (CHW) with life challenges; or both pharmacist and CHW support. Participants will be randomly placed into one of these groups.

How Is the Trial Designed?

Group I: Medication Therapy Management (MTM) Experimental Treatment 1 Intervention

Group II: MTM + CHW Experimental Treatment 2 Interventions

Group III: Community Health Worker (CHW) Experimental Treatment 1 Intervention

Group IV: Usual Care Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

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]

Community Health Workers (CHWs) play a crucial role in diabetes care by providing behavioral lifestyle interventions and helping underserved communities access healthcare services.

Despite their effectiveness in improving psychosocial and biomedical outcomes, CHWs are often underutilized in multidisciplinary teams due to a lack of recognition and standardized training, highlighting the need for strategies to better integrate them into healthcare teams.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Rationale and Logistics for Incorporating Community Health Workers Into the Multidisciplinary Team. Vaughan, EM., Cepni, AB., Le, UPN., et al.[2023]

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) significantly improve physical health outcomes, diabetes knowledge, self-care behaviors, and emotional well-being in patients with Type 2 diabetes, based on a systematic review of 17 randomized controlled trials.

There is a need for more research on the types and methods of CHW interventions, as well as understanding the mechanisms of change they facilitate, to enhance diabetes care and support for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community health workers in diabetes care: A systematic review of randomized controlled trials. Trump, LJ., Mendenhall, TJ.[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]

This study is a pragmatic, cluster-randomized trial involving 2000 patients at risk for type 2 diabetes, aiming to evaluate the effectiveness of community health workers (CHWs) in primary care settings to prevent diabetes through personalized interventions.

The trial will assess not only the incidence of diabetes but also secondary outcomes like weight loss and HbA1c levels, providing a comprehensive view of how CHWs can enhance diabetes prevention efforts in community health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for the CHORD project (community health outreach to reduce diabetes): a cluster-randomized community health worker trial to prevent diabetes. Islam, N., Gepts, T., Lief, I., et al.[2019]

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]

Community health worker interventions significantly improved HbA1c levels in adults with type 2 diabetes after 12 months, showing a mean reduction of 0.5%, which meets the minimal clinically important difference.

The review included seven studies with 1280 participants, primarily from ethnic minority groups, indicating that these interventions could be a valuable addition to diabetes care, although further cost-effectiveness analysis is needed before widespread implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the effectiveness of community health worker interventions on glycaemic control in type 2 diabetes: a systematic review and meta-analysis. Evans, J., White, P., Ha, H.[2023]

A community health worker (CHW) diabetes self-management education program significantly reduced HbA1c levels and diabetes distress in Latino adults with type 2 diabetes over 6 months compared to enhanced usual care, indicating its effectiveness in managing diabetes.

Participants who continued with a peer leader (PL) program maintained their HbA1c improvements and reported fewer depressive symptoms at 18 months, suggesting that ongoing support is crucial for sustaining diabetes management gains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes at 18 Months From a Community Health Worker and Peer Leader Diabetes Self-Management Program for Latino Adults. Spencer, MS., Kieffer, EC., Sinco, B., et al.[2022]

Citations

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

Evaluating the effectiveness of community health worker ... Outcome heterogeneity was low (I2=21%), and the overall level of certainty was high. Conclusions. CHW interventions in type 2 diabetes showed ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3222418/

Effectiveness of a Community Health Worker Intervention ... Effectiveness of a community health worker intervention among African American and Latino adults with type 2 diabetes: a randomized controlled trial.

3. chwcentral.org chwcentral.org/resources/evaluating-the-effectiveness-of-community-health-worker-interventions-on-glycaemic-control-in-type-2-diabetes-mellitus-a-systematic-review-and-meta-analysis/

Evaluating the effectiveness of community health worker ... This review looked at how community health workers (CHWs) help people with type 2 diabetes manage their blood sugar.

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

Impact of community health workers on diabetes ... This program was effective in improving diabetes management among patients living in diabetes-burdened communities, and the effects were persistent throughout ...

5. annfammed.org annfammed.org/content/22/Supplement_1/7004

Implementation Evaluation of a Community Health Worker ... Community health worker (CHW) interventions show promising outcomes for T2D and HTN control particularly among low income and historically ...

6. 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)

7. sciencedirect.com sciencedirect.com/science/article/pii/S105687272400120X?via%3Dihub

A community health worker led diabetes self-management ... Conclusions. Findings suggest that the SIMPLE trial's improved HbA1c levels stemmed from a CHW-driven intervention and not additional healthcare contact.

8. formative.jmir.org formative.jmir.org/2025/1/e79032

Assessing a Community Health Worker-Facilitated, Digitally ... Background: The high prevalence of type 2 diabetes (T2D) and associated complications disproportionately affect low-income Latino populations, ...

9. ahrq.gov ahrq.gov/downloads/pub/evidence/pdf/comhealthwork/comhwork.pdf

Outcomes of Community Health Worker Interventions To conduct a systematic review of the evidence on characteristics of community health workers (CHWs) and CHW interventions, outcomes of such interventions, ...

10. ysph.yale.edu ysph.yale.edu/news-article/perez-escamilla-receives-dollar400k-grant-to-study-novel-intervention-for-people-with-type-2-diabetes/

Study investigates impact of community health workers in ... Study investigates impact of community health workers in helping people with type 2 diabetes. By Fran Fried January 24, 2024. Can ...