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临床试验/NCT03297645
NCT03297645已完成不适用

RVA Breathes: A Richmond City Collaboration to Reduce Pediatric Asthma Disparities

Virginia Commonwealth University2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2018年5月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
500
试验地点
2
主要终点
Child Health Care Utilization

研究概览

简要总结

The goal of this study is to evaluate a sustainable, community-engaged program to reduce asthma disparities among 5 to 11-year-old children in Richmond, Virginia. Richmond, an urban center, has been named the Asthma Capital, or "most challenging place to live in the U.S. with asthma," by the Asthma and Allergy Foundation three times in the last 5 years. To date, however, the city has no comprehensive, community-engaged asthma care program for those children at highest risk for poor asthma outcomes. To address this disparity, the study team engaged with community partners and completed a mixed-methods needs assessment to enhance understanding of the barriers and supports to asthma care for children and their families living in Richmond. Several key priority areas emerged: peer support, advocacy, treating the home as a system, increased school nurse education, and coordination with schools and providers. Working together, the community-engaged team translated needs assessment findings to RVA Breathes, a program coordinating asthma care across 4 sectors: family, home, community, and medical care.

详细描述

RVA Breathes includes family-based asthma self-management education (delivered by Community Health Workers [CHWs] with the Institute for Public Health Innovation), home environmental remediation (with Richmond City Health Department's Healthy Homes Initiative), and a school nurse component (with elementary schools in the Richmond City Public School System). These interventions capitalize among existing resources and relationships with stakeholders in Richmond, each of which is committed to RVA Breathes. Two hundred-fifty children with asthma and their caregivers participated in a randomized clinical trial of RVA Breathes. After completing a baseline assessment, families were randomized to one of three conditions: 1) asthma education + home remediation + school intervention, 2) asthma education + home remediation and 3) comparator condition (Enhanced Standard of Care, E-SOC). Families participated in the program for 9 months and completed follow-up assessments (post-treatment and 3-, 6-, and 9-month) to measure changes in healthcare utilization and the impact of the program on child asthma outcomes. Conditions were compared on the primary outcome of asthma-related healthcare utilization, including asthma specific ED visits and hospital admissions. Secondary outcomes included need for controller medication use, asthma control, asthma symptoms, asthma action plans, and quality of life. We will also evaluate the sustainability of RVA Breathes after 9 months (without active intervention), including a review of qualitative data from participants and stakeholders in the program. Findings from this trial will allow for dissemination and implementation of RVA Breathes as a sustainable program in the Richmond are.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
5 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Enrolled in Richmond Public Schools
  • Asthma-related emergency department visit/hospitalization within last year
  • Physician-diagnosed asthma
  • Richmond city resident
  • Caregiver inclusion: child's legal guardian living in same home for the last 6 months

排除标准

  • Severe medical or psychiatric condition (child or caregiver)

结局指标

主要结局

Child Health Care Utilization

时间窗: Child ED visits and hospitalizations in the last 9 months (from end of intervention/control phase to 9 month follow-up assessment)

Billing systems/insurance reports of frequency of child emergency department (ED) visits and hospitalizations due to asthma. A composite variable of frequency of emergency department visits and hospitalizations will be generated to arrive at one health care utilization outcome variable.

次要结局

  • Child Asthma Symptoms(Reported by caregiver at 9 month follow-up assessment)
  • Child Quality of Life(Reported by child at 9 month follow-up assessment)
  • Child Controller Medication(Reported by caregiver at 9 month follow-up assessment)
  • Child Asthma Action Plan(Reported by caregiver at 9 month follow-up assessment)
  • Child Asthma Control(Reported for child at 9 month follow-up assessment)
  • Caregiver Quality of Life(Reported by caregivers at 9 month follow-up assessment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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