28 Participants Needed

Community Health Worker Support for Pediatric Type 1 Diabetes

CP
CW
Overseen ByCharlene W Lai, MD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Children's Hospital of Philadelphia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

The primary aim of this pilot randomized controlled trial is to determine if the integration of a Community Health Worker (CHW) into the healthcare team of children with newly diagnosed type 1 diabetes is associated with an improvement in diabetes control. The secondary objectives are to determine if utilization of CHWs is also associated with improvements in psychosocial outcomes, healthcare utilization, and decreased costs.

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.

How does the community health worker support treatment for pediatric type 1 diabetes differ from other treatments?

This treatment is unique because it involves community health workers (CHWs) who provide support and education to families managing pediatric type 1 diabetes. Unlike traditional medical treatments, CHWs focus on improving diabetes management through community-based support, addressing social barriers, and offering peer support, which can be especially beneficial for underserved communities.12345

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

Research shows that community health workers (CHWs) have been effective in managing diabetes and asthma by providing education and support to patients and families. A pilot study adapted a diabetes management program for adolescents with type 1 diabetes, showing promise in improving adherence and health outcomes when delivered by CHWs.56789

Who Is on the Research Team?

CP

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.
See 3 more

Exclusion Criteria

Tricare insurance
You do not have certain antibodies related to diabetes.
Non English speaking primary caregiver and patient
See 4 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Community Health Worker GroupExperimental Treatment1 Intervention
Group II: Standard Diabetes Care GroupActive Control1 Intervention

Find a Clinic Near You

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

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.
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 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.
"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 (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.
Community Health Workers' Role in Supporting Pediatric Asthma Management: A Review.Coutinho, MT., Subzwari, SS., McQuaid, EL., et al.[2022]

Citations

Efficacy of an education course delivered to community health workers in diabetes control: A randomized clinical trial. [2022]
"The Promotora Explained Everything": Participant Experiences During a Household-Level Diabetes Education Program. [2021]
Community Health Workers' Role in Supporting Pediatric Asthma Management: A Review. [2022]
Adaptation of an Evidence-Based Diabetes Management Intervention for Delivery in Community Settings: Findings From a Pilot Randomized Effectiveness Trial. [2022]
Applying the community health worker model to diabetes management: using mixed methods to assess implementation and effectiveness. [2011]
Effectiveness of community health workers in the care of persons with diabetes. [2022]
The role of community health workers in diabetes: update on current literature. [2022]
Using Peer Power to Reduce Health Disparities: Implementation of a Diabetes Support Coach Program in Federally Qualified Health Centers. [2023]
Teaching how, not what: the contributions of community health workers to diabetes self-management. [2018]
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