Community Health Workers in Pediatric Patients With Newly Diagnosed Type 1 Diabetes
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| ClinicalTrials.gov Identifier: NCT04238949 |
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Recruitment Status :
Recruiting
First Posted : January 23, 2020
Last Update Posted : July 29, 2020
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| 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 |
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.
| 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 |
| Arm | Intervention/treatment |
|---|---|
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No Intervention: Standard Diabetes Care Group
Patients receive standard diabetes care.
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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.
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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. |
- Hemoglobin A1c [ Time Frame: 2 years ]Improvement in glycemic control, as measured by hemoglobin A1c
- 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.
- 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.
- 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
- 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.
- 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.
- 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
- 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
- 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
- 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.
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| Ages Eligible for Study: | up to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| 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 |
| 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 | |
| Principal Investigator: | Colin P Hawkes, MD PhD | Children's Hospital of Philadelphia |
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Community Health Worker Lay Worker Community Intervention |
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Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Autoimmune Diseases Immune System Diseases |