Community Health Worker added to diabetes team for Type 1 Diabetes

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: State custody without caretaker

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

84 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Community Health Worker for Type 1 Diabetes?

Research shows that community health workers (CHWs) can effectively improve diabetes outcomes, especially in low-income and minority groups. While most studies focus on Type 2 diabetes, the CHW model has been successful in managing diabetes through education and support, suggesting potential benefits for Type 1 diabetes as well. ^{1 2 3 4 5}

Is it safe to include Community Health Workers in diabetes care teams?

The research does not specifically address safety concerns, but Community Health Workers have been successfully integrated into diabetes care teams, suggesting they are generally safe to include in such settings. ^{1 2 6 7 8}

How does adding a Community Health Worker to the diabetes care team differ from other treatments for Type 1 Diabetes?

Adding a Community Health Worker (CHW) to the diabetes care team is unique because it involves a team-based approach where CHWs provide education and support, especially for low-income and minority populations. This approach focuses on improving diabetes management through community engagement and personalized care, which is different from traditional medical treatments that primarily rely on medication and clinical visits. ^{1 2 4 5 8}

What is the purpose of this trial?

The primary aim of this randomized controlled trial is to determine if the integration of a Community Health Worker into the healthcare team is associated with an improvement in diabetes control in children with type 1 diabetes. The secondary objectives are to determine if utilization of Community Health Workers is also associated with reduced emergency department visits and hospitalizations, improved attendance at outpatient diabetes appointments, and improvements in psychosocial outcomes and diabetes control.

Research Team

Colin P Hawkes, MD PhD

Principal Investigator

Children's Hospital of Philadelphia

Eligibility Criteria

This trial is for children with type 1 diabetes for over a year, who've had multiple hospital visits or missed appointments, or have high Hemoglobin A1c levels. It's not open to children in state custody without a caretaker to manage study procedures.

Inclusion Criteria

I have been diagnosed with type 1 diabetes for over a year.

In the past year, my diabetes-related hospital visits and missed appointments add up to more than 2, or my Hemoglobin A1c is at least 9.5.

Exclusion Criteria

I am a child in state custody without a caretaker for study procedures.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive standard diabetes care or are assigned a community health worker for one year

1 year

Home visits, phone contacts, text messaging, or email

Crossover

Participants switch groups; those who received standard care now receive a community health worker and vice versa

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Treatment Details

Interventions

• Community Health Worker

Trial Overview The study tests if adding a Community Health Worker to the child's diabetes care team can improve blood sugar control and reduce emergency visits, hospital stays, and missed appointments while also helping with psychosocial challenges.

Participant Groups

Group I: Standard Diabetes Care Group Experimental Treatment 1 Intervention

Patients receive standard diabetes care for one year. They receive a community health worker for the second year (as part of a crossover trial).

Group II: Community Health Worker Group Experimental Treatment 1 Intervention

Patients are assigned a community health worker for one year, in addition to standard diabetes care. They do not receive a community health worker for the second year of the study.

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

Findings from Research

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]

A 12-month home-based intervention led by community health workers (CHWs) did not significantly lower HbA1c levels for the overall group of low-income adults with diabetes compared to usual care, indicating limited efficacy in the general population.

However, for participants with very high HbA1c levels (greater than 10%), the intervention resulted in a significant decrease in HbA1c, suggesting that CHW support may be particularly beneficial for those with poor glycemic control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of a Community Health Worker Self-Management Support Intervention Among Low-Income Adults With Diabetes, Seattle, Washington, 2010-2014. Nelson, K., Taylor, L., Silverman, J., 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]

Community Health Worker (CHW) interventions can lead to a modest reduction in hemoglobin A1c (A1c) levels in people with diabetes, with a standardized mean difference of 0.21 based on a meta-analysis of nine randomized controlled trials with at least 12 months of follow-up.

The effectiveness of CHW interventions appears to be greater in individuals with higher baseline A1c levels, suggesting that these interventions may be particularly beneficial for those with more severe diabetes management challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community Health Worker Interventions to Improve Glycemic Control in People with Diabetes: A Systematic Review and Meta-Analysis. Palmas, W., March, D., Darakjy, S., et al.[2022]

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]

In a study involving 116 participants, primarily Native Hawaiian and Samoan, community health workers (CHWs) significantly improved diabetes management, leading to a mean reduction in HbA1c of 2.2% for those receiving CHW support.

In contrast, participants without CHW intervention only experienced a minimal reduction of 0.2% in HbA1c, highlighting the effectiveness of CHWs in enhancing diabetes education and management in ethnic minority populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes management: utilizing community health workers in a Hawaiian/Samoan population. Beckham, S., Bradley, S., Washburn, A., et al.[2022]

Integrating Community Health Workers (CHWs) into diabetes group visits for low-income Hispanic adults led to significantly better clinical outcomes, including improved A1C levels and adherence to preventive care guidelines over a 6-month period with 50 participants.

Participants in the intervention group not only lost weight but also reported high satisfaction with the group visits, indicating that this approach is both effective and well-received by the community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating CHWs as Part of the Team Leading Diabetes Group Visits: A Randomized Controlled Feasibility Study. Vaughan, EM., Johnston, CA., Cardenas, VJ., et al.[2023]

References

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

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

2. 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]

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

Randomized Controlled Trial of a Community Health Worker Self-Management Support Intervention Among Low-Income Adults With Diabetes, Seattle, Washington, 2010-2014. [2022]

4. 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]

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

Community Health Worker Interventions to Improve Glycemic Control in People with Diabetes: A Systematic Review and Meta-Analysis. [2022]

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

Diabetes management: utilizing community health workers in a Hawaiian/Samoan population. [2022]

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

Integrating CHWs as Part of the Team Leading Diabetes Group Visits: A Randomized Controlled Feasibility Study. [2023]