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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding a Community Health Worker to the healthcare team can help children with type 1 diabetes manage their condition more effectively. Researchers seek to discover whether this support reduces hospital visits, improves appointment attendance, and enhances overall well-being. For one year, one group will receive additional help from a Community Health Worker, while the other group will follow standard diabetes care before switching roles in the second year. This trial suits children who have had type 1 diabetes for over a year and have experienced multiple hospital visits, ER trips, or missed diabetes appointments in the past year. As an unphased trial, it offers a unique opportunity to explore innovative support methods for managing type 1 diabetes.

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 prior data suggests that integrating a Community Health Worker is safe for children with type 1 diabetes?

Research shows that community health workers (CHWs) are generally safe and effective as part of healthcare teams. Studies have found that CHWs can improve health outcomes for at-risk individuals, such as those with diabetes.

One study demonstrated that CHWs helped people with diabetes lower their blood sugar levels without increasing doctor or hospital visits. This indicates that CHWs can be integrated into care teams without causing additional trips to healthcare providers. No serious negative effects were reported from working with CHWs.

Another review found that CHWs positively impact health, behavior, and mental well-being. This suggests they can help people manage their health better and feel more supported, with no major safety concerns.

Overall, research suggests that incorporating CHWs into healthcare teams is safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about adding a Community Health Worker (CHW) to the diabetes care team because it offers a personalized approach that complements traditional treatments like insulin therapy and glucose monitoring. Unlike the typical medical care which often involves periodic doctor visits, a CHW can provide ongoing support, education, and resources right in the patient's community. This approach aims to improve overall diabetes management by addressing social and behavioral factors that affect health, potentially leading to better long-term outcomes for people with Type 1 Diabetes.

What evidence suggests that integrating a Community Health Worker is effective for improving diabetes control in children with type 1 diabetes?

Research has shown that Community Health Workers (CHWs) can significantly aid in diabetes management. In this trial, one group of participants will receive a CHW for one year in addition to standard diabetes care, while another group will receive standard diabetes care alone for the first year and a CHW in the second year. Studies have found that patients with CHWs better control their A1C levels, an important measure of blood sugar. For children with type 1 diabetes, the presence of CHWs is linked to healthier blood sugar levels. One study found that CHW guidance lowered A1C by at least 1.0% for most people, indicating better overall diabetes control. CHWs also provide education and support, leading to fewer hospital visits and an improved quality of life. ^{2 5 6 7 8}

Who Is on the Research Team?

Colin P Hawkes, MD PhD

Principal Investigator

Children's Hospital of Philadelphia

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10869924/

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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04238949

Community Health Workers in Pediatric Patients With ... ... outcomes in children with type 1 diabetes. These children have poorer glycemic control, lower quality of life, and increased healthcare utilization.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2211335520302254

Introduction of a community health worker diabetes coach ... CHW coaching reduced hemoglobin A1c by at least 1.0% for most participants. •. Most participants with diabetes working with the CHW met glycemic control.

4. systematicreviewsjournal.biomedcentral.com systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-020-01377-8

The effectiveness of peer and community health worker-led ... COMP-DSMPs were inconsistently associated with improvements in clinical, behavioural, and psychological outcomes.

5. withpower.com withpower.com/trial/phase-diabetes-mellitus-type-1-11-2019-ad689

Community Health Worker Support for Pediatric Type 1 ... Research shows that community health workers (CHWs) have been effective in managing diabetes and asthma by providing education and support to patients and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12017050/

Adverse Social Determinants of Health in Children with ... Community health workers (CHWs) have been shown to improve outcomes in marginalized, high-risk populations.

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

A community health worker led diabetes self-management ... 5. Conclusion. This CHW-driven intervention improved HbA1c outcomes without additional healthcare utilization in individuals with and at risk for diabetes.

8. 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, ...