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临床试验/NCT04238949
NCT04238949进行中(未招募)不适用

The Impact of Community Health Workers in Pediatric Patients With Newly Diagnosed Type 1 Diabetes - A Pilot Study

Children's Hospital of Philadelphia1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2019年12月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
28
试验地点
1
主要终点
Hemoglobin A1c

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
— 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Standard Diabetes Care Group

No Intervention

Patients receive standard diabetes care.

Community Health Worker Group

Experimental

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.

干预措施: Community Health Worker added to diabetes team (Other)

结局指标

主要结局

Hemoglobin A1c

时间窗: 2 years

Improvement in glycemic control, as measured by hemoglobin A1c

次要结局

  • Subject Depression(2 years)
  • Healthcare costs(2 years)
  • Missed outpatient appointments(2 years)
  • Emergency Department utilization(2 years)
  • Hospital admissions(2 years)
  • Quality of life (primary care giver)(2 years)
  • Primary caregiver's diabetes self-efficacy(1.5 years)
  • Social Determinants of Health(2 years)
  • Caregiver Depression(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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