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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hemoglobin A1c
Secondary outcome measures
Caregiver Depression
Emergency Department utilization
Healthcare costs
+6 moreTrial 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
708 Previous Clinical Trials
8,581,247 Total Patients Enrolled
5 Trials studying Diabetes
240 Patients Enrolled for Diabetes
Leonard Davis Institute of Health EconomicsUNKNOWN
3 Previous Clinical Trials
391 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people have been admitted to the experiment?
"Affirmative, the information on clinicaltrials.gov demonstrates that this examination is actively recruiting members. This inquiry was initially posted on December 6th 2019 and most recently updated August 10th 2022; 40 patients are needed to be recruited from a single institution."
Answered by AI
Is there currently an opportunity to join this experiment?
"Per information provided on clinicaltrials.gov, this medical experiment is actively recruiting volunteers. It was first posted in December 2019 and the most recent update of its requirements occurred in August 2022."
Answered by AI
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