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Community Health Worker Support for Pediatric Type 1 Diabetes

N/A

Waitlist Available

Led By Colin P Hawkes, MD PhD

Research Sponsored by Children's Hospital of Philadelphia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1.5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether adding a Community Health Worker to the care team of children with newly diagnosed type 1 diabetes improves diabetes control, as well as other outcomes.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves adding a support role rather than a medical treatment, traditional side effects like you'd see with medications aren't expected. However, there may be indirect impacts on family dynamics or stress levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hemoglobin A1c

Secondary study objectives

Caregiver Depression

Emergency Department utilization

Healthcare costs

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Community Health Worker GroupExperimental Treatment1 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 GroupActive Control1 Intervention

Patients receive standard diabetes care.

Do I qualify?Apply below to find out