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?

The purpose of the study is to learn about the best way to enhance pharmacy-related care for diabetes self-management. This research is being done because we want to improve use of medicines and diabetes management among adults with type 2 diabetes and find out which of type of support may improve diabetes self-management for adults. Participants will be assigned to one of 4 groups, and will either: * receive care as usual; or, * receive added medicine management support from a pharmacist; or, * receive support from a Community Health Worker (CHW) to address life challenges; or, * receive both the pharmacist medicine management and the CHW support

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 the combination of MTM and CHW support safe for humans?

The research does not provide specific safety data for the combination of Medication Therapy Management (MTM) and Community Health Worker (CHW) support, but CHWs have been used safely in various healthcare settings to support diabetes care. ^{1 2 3 4 5}

How does the MTM + CHW Support treatment for type 2 diabetes differ from other treatments?

The MTM + CHW Support treatment is unique because it combines medication therapy management (MTM) with the support of community health workers (CHWs), who help patients manage their diabetes through education and lifestyle interventions. This approach leverages the trust and accessibility of CHWs to improve diabetes self-management, especially in underserved communities, which is not typically a focus of standard diabetes treatments. ^{1 2 5 6 7}

What data supports the effectiveness of the treatment CHW, MTM for Type 2 Diabetes?

Research shows that community health workers (CHWs) can help people with type 2 diabetes manage their condition better by providing education and support. Studies have found that CHW programs can lead to improvements in blood sugar control and other health outcomes over time. ^{5 6 7 8 9}

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

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

Participating in another lifestyle, or medication adherence program

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

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]

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]

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]

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 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]

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]

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) 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]

Citations

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

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

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

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

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

Outcomes at 18 Months From a Community Health Worker and Peer Leader Diabetes Self-Management Program for Latino Adults. [2022]

4. 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]

5. England 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. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

The Rationale and Logistics for Incorporating Community Health Workers Into the Multidisciplinary Team. [2023]

8. England 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. [2019]

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

Community health workers in diabetes care: A systematic review of randomized controlled trials. [2022]