Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
300

Summary

Conditions
Asthma
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Prevention

Participation Requirements

Age
Between 5 years and 11 years
Gender
Both males and females

Description

RVA Breathes includes family-based asthma self-management education (delivered by Community Health Workers [CHWs] with the Institute for Public Health Innovation), homeenvironmental remediation (with Richmond City Health Department's Healthy Homes Initiative), and a schoolnurse component (with eleme...

RVA Breathes includes family-based asthma self-management education (delivered by Community Health Workers [CHWs] with the Institute for Public Health Innovation), homeenvironmental remediation (with Richmond City Health Department's Healthy Homes Initiative), and a schoolnurse 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. Three-hundred children with asthma and their caregivers will participate in a randomized clinical trial of RVA Breathes. After completing a baseline assessment, families will be 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 will participate in the program for 9 months and complete 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 will be compared on the primary outcomes of healthcare utilization, including asthma specific ED visits and hospital admissions, school absences, and controller medication use; secondary outcomes include asthma control, symptoms, 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.

Tracking Information

NCT #
NCT03297645
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Robin Everhart, PhD Virginia Commonwealth University