Trials / Completed
CompletedNCT03297645
RVA Breathes: A Richmond City Collaboration to Reduce Pediatric Asthma Disparities
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 500 (actual)
- Sponsor
- Virginia Commonwealth University · Academic / Other
- Sex
- All
- Age
- 5 Years – 11 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | School | CHWs will ensure that families submit required health paperwork (e.g., asthma action plan, medication release form) and confirm with school nurses that children have the appropriate medications. School nurses will be given a standardized protocol to follow with clear guidelines for caring for students with asthma. The CHW assigned to the family will work with the school nurse to ensure that communication with the medical provider is occurring. |
| BEHAVIORAL | Asthma education | CHWs will deliver evidence-based asthma education to parents and children. Content is drawn from existing asthma management programs, and adapted for families in Richmond. Between sessions, CHWs will call parents at least monthly to check in and assess family asthma management, including healthcare utilization since the last contact. |
| BEHAVIORAL | Home environmental remediation | Healthy Homes will complete home-based environmental assessments using evidence-based protocols. Healthy Homes will provide real-time education and share information about their findings and recommendations for action. Families are provided with low-cost intervention materials (e.g., filters, pillow covers), as well as behavioral modifications to aid in the reduction of asthma triggers in the home. |
| BEHAVIORAL | Informational mail | Family will be mailed publicly available asthma information every 3 months. |
Timeline
- Start date
- 2018-05-31
- Primary completion
- 2022-06-30
- Completion
- 2022-06-30
- First posted
- 2017-09-29
- Last updated
- 2023-10-06
- Results posted
- 2023-10-06
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03297645. Inclusion in this directory is not an endorsement.