Community Health Workers in Pediatric Patients With Newly Diagnosed Type 1 Diabetes

February 10, 2026 updated by: Children's Hospital of Philadelphia

The Impact of Community Health Workers in Pediatric Patients With Newly Diagnosed Type 1 Diabetes - A Pilot Study

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Lower socioeconomic status (SES) is associated with adverse outcomes in children with type 1 diabetes. These children have poorer glycemic control, lower quality of life, and increased healthcare utilization. Previous efforts to improve outcomes in this patient population have focused on high-cost, high-intensity educational interventions. These efforts have been ineffective in improving clinical outcomes in patients with low SES. Adverse social determinants of health (SDOH) including food insecurity, parental unemployment and housing insecurity are extremely prevalent in under-resourced patients and their families.

Community health workers (CHWs) are trained non-medical members of the community who are empowered to address adverse SDOH through home visits and connecting patients to community resources. CHWs can assist in navigating healthcare and social services systems, reducing family stress, and breaking down community barriers to positive health behavior.

Investigators hypothesize that interventions focused on addressing adverse SDOH will reduce barriers to optimal diabetes outcomes in this patient population.

At the diabetes center at The Children's Hospital of Philadelphia (CHOP), a CHW will be assigned for one year to newly diagnosed patients with type 1 diabetes with government insurance. The support provided for this year will be tailored to the patient's needs, and may include problem solving surrounding issues related to work/education, accessing healthcare/medications, engagement with the healthcare team, transportation, housing or food insecurity. Interactions with patients will be through home visits, telephone encounters, text messaging or email. Patients will be followed for a total of two years to evaluate if improvements in outcomes are sustained after the discontinuation of CHW support.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Males or females aged < 17 years old
  • Within 31 days of clinical diagnosis of Type 1 Diabetes (T1D)
  • Government insurance at time of enrollment
  • Patient lives in a zip code in Pennsylvania within a 30-minute drive of Children's Hospital of Philadelphia (CHOP) Buerger Center for Advanced Pediatric Care at time of enrollment
  • Plans on completing the "Type 1 Year 1" program at CHOP, an intensive T1D education program that is standard of care for all newly diagnosed patients with T1D at CHOP
  • Diabetes autoantibody positive
  • English speaking caregiver and patient

Exclusion Criteria:

  • Diabetes autoantibody negative
  • Children in custody of the State where there is no identified caretaker who can complete study procedures
  • Non English speaking primary caregiver and patient
  • Medicare insurance
  • Tricare insurance
  • Move to a zip code greater than a 60-minute drive from CHOP Buerger Center for Advanced Pediatric Care during the course of the study
  • Move to a zip code not in Pennsylvania during the course of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard Diabetes Care Group
Patients receive standard diabetes care.
Experimental: Community Health Worker Group
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.
Other: Community Health Worker added to diabetes team
A Community Health Worker will be added to the diabetes team caring for a child with new onset type 1 diabetes for 1 year. The intervention includes social determinants of health screening and goal setting, with home visits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1c
Time Frame: 2 years
Improvement in glycemic control, as measured by hemoglobin A1c
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital admissions
Time Frame: 2 years
Data will be extracted from the medical record of each patient to obtain information on the number of hospital admissions.
2 years
Missed outpatient appointments
Time Frame: 2 years
Data will be extracted from the medical record of each patient to obtain information on the number of attended outpatient appointments.
2 years
Emergency Department utilization
Time Frame: 2 years
Data will be extracted from the medical record of each patient to obtain information about the number of Emergency Department (ED) visits
2 years
Quality of life (primary care giver)
Time Frame: 2 years
The primary care giver will complete the 36-item "PedsQL Health related quality of life for parents of children with chronic disease" questionnaire using a 5-point Likert rating scale to assess how their child's illness has had an impact on their quality of life. This scale ranges in score from 0 to 144, with higher scores consistent with decreased quality of life.
2 years
Primary caregiver's diabetes self-efficacy
Time Frame: 1.5 years
The 17-item, "Parental self efficacy in diabetes scale" will be completed by the primary caregiver using a 5-point Likert rating scale. The questionnaire will provide information to assess glycemic control, and sub analysis of results related to diabetes management, problem solving and teaching. This scale ranges in score from 17 to 85, with higher scores consistent with increased self-efficacy.
1.5 years
Social Determinants of Health
Time Frame: 2 years
The primary care giver will complete the 11-item "Health Leads USA Social Determinants of Health" questionnaire using a Yes/No rating scale to assess challenges with Social Determinants of Health
2 years
Caregiver Depression
Time Frame: 2 years
The primary caregiver will complete the 9-item "Patient Health Questionnaire-9" using a 4-point Likert rating scale to assess their risk of depression. This scale ranges in score from 0 to 27, with higher scores consistent with increased risk of depression
2 years
Subject Depression
Time Frame: 2 years
Subjects greater than 12 years old will complete the 13-item "Patient Health Questionnaire Modified for Adolescents" using a 4-point Likert rating scale and 4 Yes/No questions to assess their risk of depression. The Likert scale total ranges in score from 0 to 27, with higher scores consistent with increased risk of depression
2 years
Healthcare costs
Time Frame: 2 years
Data will be extracted from the medical record of each patient to obtain information on healthcare charges and hospital reimbursement.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Philadelphia

Collaborators

University of Pennsylvania

Investigators

  • Principal Investigator: Colin P Hawkes, MD PhD, Children's Hospital of Philadelphia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2019

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

January 21, 2020

First Submitted That Met QC Criteria

January 21, 2020

First Posted (Actual)

January 23, 2020

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-016871

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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