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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
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 moreAwards & 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.
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Who is running the clinical trial?
Children's Hospital of PhiladelphiaLead Sponsor
731 Previous Clinical Trials
8,473,012 Total Patients Enrolled
5 Trials studying Diabetes
240 Patients Enrolled for Diabetes
Leonard Davis Institute of Health EconomicsUNKNOWN
3 Previous Clinical Trials
411 Total Patients Enrolled
Colin P Hawkes, MD PhDPrincipal InvestigatorChildren's Hospital of Philadelphia
1 Previous Clinical Trials
84 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You do not have certain antibodies related to diabetes.I will not move more than a 60-minute drive away from CHOP Buerger Center during the study.I am younger than 17 years old.I was diagnosed with Type 1 Diabetes less than a month ago.I plan to complete the 'Type 1 Year 1' program at CHOP for my newly diagnosed Type 1 Diabetes.I have tested positive for diabetes-related antibodies.I am a child in state custody without a caretaker for study procedures.My caregiver and I can communicate in English.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Diabetes Care Group
- Group 2: Community Health Worker Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.