Community Health Worker Support for Pediatric Type 1 Diabetes

Overseen By Charlene W Lai, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: Autoantibody negative, Non English, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if including a Community Health Worker (CHW) in the care team can help children with newly diagnosed type 1 diabetes manage their condition more effectively. Researchers seek to discover whether CHWs can also enhance emotional well-being and reduce healthcare visits and costs. Participants will either receive standard diabetes care or receive additional support from a CHW alongside standard care for one year. The trial seeks children diagnosed with type 1 diabetes within the last month, who have government insurance, and live near the Children's Hospital of Philadelphia. As an unphased trial, this study offers a unique opportunity to explore innovative care strategies that could improve a child's diabetes management and overall well-being.

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 is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the integration of a Community Health Worker is safe for children with type 1 diabetes?

Research has shown that community health workers (CHWs) successfully help manage diabetes. They provide education and support, leading to better health outcomes, such as improved blood sugar levels. Past studies demonstrated that CHWs improved health without increasing doctor visits or hospital stays. No reports have indicated harmful effects from working with CHWs, suggesting that including a CHW on a healthcare team is generally safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using community health workers to support pediatric Type 1 diabetes care because this approach adds a human touch that current treatments lack. Unlike standard care, which typically involves medical professionals and technology, this method leverages the personal connection and ongoing support that community health workers offer. This can help families navigate the daily challenges of managing diabetes more effectively, potentially improving adherence to treatment and overall health outcomes. By integrating community health workers into the care team, there's hope for a more holistic approach that goes beyond just medical management.

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

Research shows that community health workers (CHWs) can improve diabetes management. In this trial, some participants will receive support from a community health worker for the first year, in addition to standard diabetes care. Studies have found a small but significant reduction in A1c levels, a key measure of blood sugar control, compared to regular care. This improvement is even greater for patients who start with higher A1c levels. CHWs provide education and support, which can enhance quality of life and reduce healthcare visits. Their success in addressing other long-term health issues suggests they could also assist with using diabetes devices. Overall, adding CHWs to care teams has shown promising results in managing type 1 diabetes in children. ^{2 3 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 under 17 with new Type 1 Diabetes, covered by government insurance, living within a 30-minute drive of CHOP in Pennsylvania. They must be autoantibody positive and plan to complete the 'Type 1 Year 1' program at CHOP. Excluded are those who are autoantibody negative, non-English speaking, or have certain insurances.

Inclusion Criteria

Government insurance at time of enrollment

I am younger than 17 years old.

I was diagnosed with Type 1 Diabetes less than a month ago.

Exclusion Criteria

Tricare insurance

I will not move more than a 60-minute drive away from CHOP Buerger Center during the study.

Non English speaking primary caregiver and patient

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Community Health Worker (CHW) is assigned to newly diagnosed patients for one year to address social determinants of health and improve diabetes outcomes

1 year

Home visits, telephone encounters, text messaging or email

Follow-up

Participants are monitored for sustained improvements in outcomes after the discontinuation of CHW support

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Community Health Worker

Trial Overview The study tests if adding a Community Health Worker (CHW) to the diabetes care team helps manage children's newly diagnosed Type 1 Diabetes better. It looks at diabetes control, psychosocial outcomes, healthcare use, and costs.

How Is the Trial Designed?

Group I: Community Health Worker Group Experimental Treatment 1 Intervention

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

Group II: Standard Diabetes Care Group Active Control 1 Intervention

Patients receive standard diabetes care.

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Leonard Davis Institute of Health Economics

Collaborator

Trials

4

Recruited

440+

Published Research Related to This Trial

Community Health Workers (CHWs) have proven effective in improving asthma management and education for children and their families, as shown in a review of 15 studies conducted in the U.S.

The Rhode Island Integrated Response Asthma Care Implementation Program (RI-AIR) highlights the importance of CHWs in providing services like home assessments and resource linkage, emphasizing the need for further research on integrating CHWs into healthcare teams and ensuring their services are reimbursed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community Health Workers' Role in Supporting Pediatric Asthma Management: A Review. Coutinho, MT., Subzwari, SS., McQuaid, EL., 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 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]

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]

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]

Community health workers play a valuable role in diabetes care, with studies showing increased participant knowledge and satisfaction, particularly among minority populations in the USA.

Some interventions involving community health workers led to improvements in physiological measures and positive lifestyle changes, although more research is needed to fully understand their impact and optimal roles in diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of community health workers in the care of persons with diabetes. Norris, SL., Chowdhury, FM., Van Le, K., et al.[2022]

The REACH for Control (RFC) intervention, delivered by community health workers, showed significant improvements in hemoglobin A1c (HbA1c) levels and quality of life for adolescents with poorly controlled type 1 diabetes, compared to standard care.

Caregivers found the RFC intervention to be acceptable, although the frequency of follow-up sessions for skills practice was lower than intended, indicating a need for adjustments in future implementations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptation of an Evidence-Based Diabetes Management Intervention for Delivery in Community Settings: Findings From a Pilot Randomized Effectiveness Trial. Ellis, DA., Carcone, AI., Naar-King, S., et al.[2022]

Citations

1. 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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4471021/

Community Health Worker Interventions to Improve Glycemic ... CHW interventions showed a modest reduction in A1c compared to usual care. A1c reduction was larger in studies with higher mean baseline A1c. Caution is ...

3. 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 ...

4. clinicaltrial.be clinicaltrial.be/en/details/58637?per_page=20&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_eligible=0&only_active=0

Community Health Workers in Pediatric Patients With Newly... These children have poorer glycemic control, lower quality of life, and increased healthcare utilization. Previous efforts to improve outcomes ...

5. diabetes.jmir.org diabetes.jmir.org/2025/1/e76387

A Web-Based Qualitative Study Using Human-Centered ... The success of the CHW model in other chronic childhood conditions suggests that a CHW care model can potentially improve diabetes device uptake ...

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

Adverse Social Determinants of Health in Children with ... Abstract. Objective. There are significant socioeconomic and racial disparities in glycemic control among children with type 1 diabetes (T1D).

7. karger.com karger.com/article/doi/10.1159/000548002

Team-Based Pediatric Type 1 Diabetes Care in the USA The data in this table are based on the following question: what is the scheduling/billing routine for the services provided by CDCES (educator) ...

8. 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.