An interventional study of Community Health Worker added to diabetes team in Type 1 Diabetes, Diabetes Mellitus and Psychosocial Problem, sponsored by Children's Hospital of Philadelphia. Active, not recruiting at 1 site in United States. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2026-02-12.
Sponsored by Children's Hospital of Philadelphia · Not applicable, Interventional, and Health services research
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.
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.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's enrollment of 28 is below the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Children's Hospital of Philadelphia is the lead sponsor of 480 studies on the registry; 85 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receive standard diabetes care.
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.
Hemoglobin A1c
Improvement in glycemic control, as measured by hemoglobin A1c
Time frame: 2 years
Hospital admissions
Data will be extracted from the medical record of each patient to obtain information on the number of hospital admissions.
Time frame: 2 years
Missed outpatient appointments
Data will be extracted from the medical record of each patient to obtain information on the number of attended outpatient appointments.
Time frame: 2 years
Emergency Department utilization
Data will be extracted from the medical record of each patient to obtain information about the number of Emergency Department (ED) visits
Time frame: 2 years
Quality of life (primary care giver)
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.
Time frame: 2 years
Primary caregiver's diabetes self-efficacy
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.
Time frame: 1.5 years
Social Determinants of Health
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
Time frame: 2 years
Caregiver Depression
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
Time frame: 2 years
Subject Depression
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
Time frame: 2 years
Healthcare costs
Data will be extracted from the medical record of each patient to obtain information on healthcare charges and hospital reimbursement.
Time frame: 2 years
Plan to share: No
This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Children's Hospital of Philadelphia