Clinical trial NCT03297645: RVA Breathes: A Richmond City Collaboration to Reduce Pediatric Asthma Disparities
Official title: RVA Breathes: A Richmond City Collaboration to Reduce Pediatric Asthma Disparities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-09-29
Enrollment: 500
Sex: ALL
Minimum age (years): 5
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Severe medical or psychiatric condition (child or caregiver)

Primary outcomes:
measure: Child Health Care Utilization
timeFrame: Child ED visits and hospitalizations in the last 9 months (from end of intervention/control phase to 9 month follow-up assessment)
Secondary outcomes:
measure: Child Controller Medication
timeFrame: Reported by caregiver at 9 month follow-up assessment
measure: Child Asthma Action Plan
timeFrame: Reported by caregiver at 9 month follow-up assessment
measure: Child Asthma Control
timeFrame: Reported for child at 9 month follow-up assessment
measure: Child Asthma Symptoms
timeFrame: Reported by caregiver at 9 month follow-up assessment
measure: Child Quality of Life
timeFrame: Reported by child at 9 month follow-up assessment
measure: Caregiver Quality of Life
timeFrame: Reported by caregivers at 9 month follow-up assessment
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Robin Everhart, PhD
role: PRINCIPAL_INVESTIGATOR
References: