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

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ClinicalTrials.gov Identifier: NCT03475108
Recruitment Status : Recruiting
First Posted : March 23, 2018
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

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.

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

Detailed Description:

Diabetic ketoacidosis accounts for 65% of hospitalizations in pediatric patients with type 1 diabetes, and has a mortality rate between 0.15-0.31%. Children with established type 1 diabetes have an 8% annualized risk of developing diabetic ketoacidosis, and this risk increases during adolescence. In addition, socioeconomic and racial disparities are associated with increased risks of poor glycemic control, hospitalization with diabetic ketoacidosis, and even severe hypoglycemia. All of these complications are associated with preventable harm, and lead to increased utilization of medical resources, both in the short- and long-term. Social determinants of health account for over 75% of health outcomes. Thus, it is not surprising that a disproportionate number of children with poor diabetes control and recurrent hospitalization in diabetic ketoacidosis come from vulnerable underserved populations.

In this study, Investigators will study the effect of integrating a community-based healthcare worker into the healthcare team of children with poorly controlled type 1 diabetes. Community Health Workers (CHW) are highly motivated, community members who do not necessarily have prior medical training, but rather they link with the healthcare team to identify and provide relevant social supports to the family. They receive specific training that focuses on issues relevant to improving health outcomes and adherence, by improving medication access, reducing food insecurity, and improving health literacy. The CHW are able to provide real-time assistance with navigating the healthcare and social services systems, reducing family stress and breaking down community barriers to positive health behavior. The CHW work with the family to develop goals and develop an individualized plan to reach these goals. The role of the CHW can include home visits, phone contacts, meeting with school representatives and accompanying patients to appointments.

At the diabetes center at The Children's Hospital of Philadelphia (CHOP), the Community Health Worker will be assigned for one year to patients with high healthcare utilization and / or poorly controlled type 1 diabetes. The support provided for this year will be tailored to the patient's needs but 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. This will be added to their medical care and will be documented in the patient's medical record.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Integrating Community Health Workers Into the Care of Children With Type 1 Diabetes
Actual Study Start Date : April 19, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Community Health Worker Group
Patients are assigned a community health worker for one year, in addition to standard diabetes care.
Other: Community Health Worker added to diabetes team
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.

No Intervention: Standard Diabetes Care Group
Patients receive standard diabetes care.



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. Attended 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. 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 missed outpatient appointments.

  4. 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.

  5. Primary caregiver's diabetes self-efficacy [ Time Frame: 2 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. 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 (HCCQ) 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.



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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

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): NCT03475108


Contacts
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Contact: Colin P Hawkes, MD PhD 215-590-3174 hawkesc@email.chop.edu
Contact: Terri H Lipman, CRNP PhD 215-590-3174 lipman@nursing.upenn.edu

Locations
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United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Colin Hawkes, MD PhD    215-590-3174    hawkesc@email.chop.edu   
Sponsors and Collaborators
Children's Hospital of Philadelphia
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: NCT03475108     History of Changes
Other Study ID Numbers: 18-014828
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: April 2019
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

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