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

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ClinicalTrials.gov Identifier: NCT04238949
Recruitment Status : Recruiting
First Posted : January 23, 2020
Last Update Posted : July 29, 2020
Sponsor:
Collaborator:
Leonard Davis Institute of Health Economics
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Diabetes Mellitus Psychosocial Problem Compliance, Patient Health Behavior Other: Community Health Worker added to diabetes team Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pilot Randomized Controlled Trial
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Impact of Community Health Workers in Pediatric Patients With Newly Diagnosed Type 1 Diabetes - A Pilot Study
Actual Study Start Date : December 6, 2019
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

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.




Primary Outcome Measures :
  1. Hemoglobin A1c [ Time Frame: 2 years ]
    Improvement in glycemic control, as measured by hemoglobin A1c


Secondary Outcome Measures :
  1. 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. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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

  7. 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

  8. 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

  9. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04238949


Contacts
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Contact: Charlene W Lai, MD 215-590-3174 laicw@email.chop.edu
Contact: Colin P Hawkes, MD PhD 215-590-3174 hawkesc@email.chop.edu

Locations
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United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Charlene W Lai, MD    215-590-3174    laicw@email.chop.edu   
Contact: Colin P Hawkes, MD PhD    215-590-3174    hawkesc@email.chop.edu   
Principal Investigator: Colin P Hawkes, MD PhD         
Sub-Investigator: Terri H Lipman, PhD CRNP         
Sub-Investigator: Charlene W Lai, MD         
Sponsors and Collaborators
Children's Hospital of Philadelphia
Leonard Davis Institute of Health Economics
Investigators
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Principal Investigator: Colin P Hawkes, MD PhD Children's Hospital of Philadelphia
Publications:
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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT04238949    
Other Study ID Numbers: 19-016871
First Posted: January 23, 2020    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital of Philadelphia:
Community Health Worker
Lay Worker
Community Intervention
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases