search
Back to results

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

Primary Purpose

Type 1 Diabetes, Diabetes Mellitus, Psychosocial Problem

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Community Health Worker added to diabetes team
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Type 1 Diabetes focused on measuring Community Health Worker, Lay Worker, Community Intervention

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Diabetes Care Group

Community Health Worker Group

Arm Description

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.

Outcomes

Primary Outcome Measures

Hemoglobin A1c
Improvement in glycemic control, as measured by hemoglobin A1c

Secondary Outcome Measures

Hospital admissions
Data will be extracted from the medical record of each patient to obtain information on the number of hospital admissions.
Missed outpatient appointments
Data will be extracted from the medical record of each patient to obtain information on the number of attended outpatient appointments.
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
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.
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.
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
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
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
Healthcare costs
Data will be extracted from the medical record of each patient to obtain information on healthcare charges and hospital reimbursement.

Full Information

First Posted
January 21, 2020
Last Updated
April 12, 2023
Sponsor
Children's Hospital of Philadelphia
Collaborators
Leonard Davis Institute of Health Economics
search

1. Study Identification

Unique Protocol Identification Number
NCT04238949
Brief Title
Community Health Workers in Pediatric Patients With Newly Diagnosed Type 1 Diabetes
Official Title
The Impact of Community Health Workers in Pediatric Patients With Newly Diagnosed Type 1 Diabetes - A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 6, 2019 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
Leonard Davis Institute of Health Economics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Diabetes Mellitus, Psychosocial Problem, Compliance, Patient, Health Behavior
Keywords
Community Health Worker, Lay Worker, Community Intervention

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pilot Randomized Controlled Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Diabetes Care Group
Arm Type
No Intervention
Arm Description
Patients receive standard diabetes care.
Arm Title
Community Health Worker Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Community Health Worker added to diabetes team
Intervention Description
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 Measure Information:
Title
Hemoglobin A1c
Description
Improvement in glycemic control, as measured by hemoglobin A1c
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Hospital admissions
Description
Data will be extracted from the medical record of each patient to obtain information on the number of hospital admissions.
Time Frame
2 years
Title
Missed outpatient appointments
Description
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
Title
Emergency Department utilization
Description
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
Title
Quality of life (primary care giver)
Description
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
Title
Primary caregiver's diabetes self-efficacy
Description
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
Title
Social Determinants of Health
Description
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
Title
Caregiver Depression
Description
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
Title
Subject Depression
Description
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
Title
Healthcare costs
Description
Data will be extracted from the medical record of each patient to obtain information on healthcare charges and hospital reimbursement.
Time Frame
2 years

10. Eligibility

Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colin P Hawkes, MD PhD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17011326
Citation
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.
Results Reference
background
PubMed Identifier
24515422
Citation
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.
Results Reference
background
PubMed Identifier
24011745
Citation
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.
Results Reference
background
PubMed Identifier
23914987
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs