Community Health Workers in Pediatric Patients With Newly Diagnosed Type 1 Diabetes
NCT ID: NCT04238949
Last Updated: 2025-03-05
Study Results
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Basic Information
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ACTIVE_NOT_RECRUITING
NA
28 participants
INTERVENTIONAL
2019-12-06
2026-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Standard Diabetes Care Group
Patients receive standard diabetes care.
No interventions assigned to this group
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
17 Years
ALL
No
Sponsors
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University of Pennsylvania
OTHER
Children's Hospital of Philadelphia
OTHER
Responsible Party
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Principal Investigators
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Colin P Hawkes, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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19-016871
Identifier Type: -
Identifier Source: org_study_id
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