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

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Behavioral: School; Behavioral: Informational mail; Behavioral: Asthma education; Behavioral: Home environmental remediation

• Registration Number: NCT03297645
• Lead Sponsor: Virginia Commonwealth University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-09-08
• Study First Submitted QC: 2017-09-25
• Study First Posted: 2017-09-29
• Study Start: 2018-05-31
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Results First Submitted: 2023-06-29
• Status Verified: 2023-09
• Results First Submitted QC: 2023-09-12
• Last Update Submitted: 2023-09-12
• Results First Posted: 2023-10-06
• Last Update Posted: 2023-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

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Exclusion Criteria

• Severe medical or psychiatric condition (child or caregiver)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Asthma education	school + asthma education + home environment remediation
Arm 1	School	school + asthma education + home environment remediation
Arm 2	Asthma education	asthma education + home environment remediation
Arm 3	Informational mail	enhanced standard of care
Arm 1	Home environmental remediation	school + asthma education + home environment remediation
Arm 2	Home environmental remediation	asthma education + home environment remediation

Primary Outcome Measures

Name	Time	Method
Child Health Care Utilization	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.

Secondary Outcome Measures

Name	Time	Method
Child Asthma Symptoms	Reported by caregiver at 9 month follow-up assessment	Caregivers report number of days in the last 7 days that their child had asthma symptoms.
Child Quality of Life	Reported by child at 9 month follow-up assessment	Children will complete a measure, the Pediatric Asthma Quality of Life Questionnaire, that assesses their level of quality of life related to child asthma; higher scores = better QOL. Total scores range from 1 to 7 and are an average of 23 items.
Child Controller Medication	Reported by caregiver at 9 month follow-up assessment	Prescription for a controller medication (caregiver report)
Child Asthma Action Plan	Reported by caregiver at 9 month follow-up assessment	Caregivers reported whether their child had an updated asthma action plan for their child.
Child Asthma Control	Reported for child at 9 month follow-up assessment	Child and caregiver complete the Childhood Asthma Control Test, which measures the frequency of daytime and nighttime asthma symptoms, activity limitations, and perception of disease control; higher scores = better asthma control. Total range of scores are from 0 to 27 and are a sum of scores.
Caregiver Quality of Life	Reported by caregivers at 9 month follow-up assessment	Parents complete a measure that assesses their level of quality of life (QOL) related to child asthma. The measure is the Pediatric Asthma Caregiver Quality of Life Questionnaire; higher scores = better QOL. A total score is determined from an average of items. Total scores range from 1 to 7.

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States