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

NCT04238949 | Active Not Recruiting DMC

• 1 other identifier: 19-016871
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 1 Diabetes; Diabetes Mellitus; Psychosocial Problem; Compliance, Patient; Health Behavior

Keywords

Community Health Worker; Lay Worker; Community Intervention

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c

  Improvement in glycemic control, as measured by hemoglobin A1c

  2 years

Secondary Outcomes (9)

• Hospital admissions

  2 years

• Missed outpatient appointments

  2 years

• Emergency Department utilization

  2 years

• Quality of life (primary care giver)

  2 years

• Primary caregiver's diabetes self-efficacy

  1.5 years

Study Arms (2)

Standard Diabetes Care Group

NO INTERVENTION

Patients receive standard diabetes care.

Community Health Worker Group

EXPERIMENTAL

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

Interventions

Community Health Worker added to diabetes team OTHER

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.

Community Health Worker Group

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• University of Pennsylvania: collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (5)

• Hassan K, Loar R, Anderson BJ, Heptulla RA. The role of socioeconomic status, depression, quality of life, and glycemic control in type 1 diabetes mellitus. J Pediatr. 2006 Oct;149(4):526-31. doi: 10.1016/j.jpeds.2006.05.039.

  PMID: 17011326 BACKGROUND

• Kangovi S, Mitra N, Grande D, White ML, McCollum S, Sellman J, Shannon RP, Long JA. Patient-centered community health worker intervention to improve posthospital outcomes: a randomized clinical trial. JAMA Intern Med. 2014 Apr;174(4):535-43. doi: 10.1001/jamainternmed.2013.14327.

  PMID: 24515422 BACKGROUND

• Raphael JL, Rueda A, Lion KC, Giordano TP. The role of lay health workers in pediatric chronic disease: a systematic review. Acad Pediatr. 2013 Sep-Oct;13(5):408-20. doi: 10.1016/j.acap.2013.04.015.

  PMID: 24011745 BACKGROUND

• Katz ML, Volkening LK, Butler DA, Anderson BJ, Laffel LM. Family-based psychoeducation and Care Ambassador intervention to improve glycemic control in youth with type 1 diabetes: a randomized trial. Pediatr Diabetes. 2014 Mar;15(2):142-50. doi: 10.1111/pedi.12065. Epub 2013 Aug 5.

  PMID: 23914987 BACKGROUND

• Lai CW, Craven M, Hershey JA, Lipman TH, Hawkes CP. Adverse Social Determinants of Health in Children with Newly Diagnosed Type 1 Diabetes: A Potential Role for Community Health Workers. Pediatr Diabetes. 2024 Jan 23;2024:8810609. doi: 10.1155/2024/8810609. eCollection 2024.

  PMID: 40302949 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus; Patient Compliance; Health Behavior

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Behavior

Study Officials

• Colin P Hawkes, MD PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot Randomized Controlled Trial

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: January 23, 2020
• Study Start: December 6, 2019
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)