Integrating Community Health Workers Into the Care of Children With Type 1 Diabetes

NCT03475108 | Completed

• 1 other identifier: 18-014828
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this randomized controlled trial is to determine if the integration of a Community Health Worker into the healthcare team is associated with an improvement in diabetes control in children with type 1 diabetes. The secondary objectives are to determine if utilization of Community Health Workers is also associated with reduced emergency department visits and hospitalizations, improved attendance at outpatient diabetes appointments, and improvements in psychosocial outcomes and diabetes control.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c

  Improvement in glycemic control, as measured by hemoglobin A1c

  2 years

Secondary Outcomes (6)

• Hospital admissions

  2 years

• Attended outpatient appointments

  2 years

• Missed outpatient appointments

  2 years

• Emergency Department utilization

  2 years

• Primary caregiver's diabetes self-efficacy

  2 years

Study Arms (2)

Community Health Worker Group

EXPERIMENTAL

Patients are assigned a community health worker for one 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

Standard Diabetes Care Group

OTHER

Patients receive standard diabetes care for one year. They receive a community health worker for the second year (as part of a crossover trial).

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 type 1 diabetes over 1 year. The intervention includes social determinants of health screening and goal setting, with home visits.

Community Health Worker Group; Standard Diabetes Care Group

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• A clinical diagnosis of type 1 diabetes for \> 1 year
• Either:
• Over the previous one year, the sum of the following should be \> 2: diabetes-related hospitalizations plus emergency department visits plus missed appointments (on separate days) or Hemoglobin A1c ≥ 9.5 at the time of enrollment.

You may not qualify if:

• Children in custody of the State where there is no identified caretaker who can complete study procedures

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (5)

• Rewers A, Chase HP, Mackenzie T, Walravens P, Roback M, Rewers M, Hamman RF, Klingensmith G. Predictors of acute complications in children with type 1 diabetes. JAMA. 2002 May 15;287(19):2511-8. doi: 10.1001/jama.287.19.2511.

  PMID: 12020331 BACKGROUND

• 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

• Laffel LM, Brackett J, Ho J, Anderson BJ. Changing the process of diabetes care improves metabolic outcomes and reduces hospitalizations. Qual Manag Health Care. 1998 Sep;6(4):53-62. doi: 10.1097/00019514-199806040-00006.

  PMID: 10339045 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

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Patient Compliance; Diabetes Mellitus

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; Health Behavior; 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: Randomized Controlled Crossover Trial

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 23, 2018
• Study Start: April 19, 2018
• Primary Completion: March 10, 2021
• Study Completion: March 10, 2021
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)