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

• ClinicalTrials.gov Identifier: NCT03297645
• Recruitment Status: Completed
• First Posted: September 29, 2017
• Last Update Posted: July 6, 2022
• Sponsor: Virginia Commonwealth University
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Virginia Commonwealth University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Asthma	Behavioral: School; Behavioral: Asthma education; Behavioral: Home environmental remediation; Behavioral: Informational mail	Not Applicable

Detailed 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 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 250 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: RVA Breathes: A Richmond City Collaboration to Reduce Pediatric Asthma Disparities
• Actual Study Start Date: May 31, 2018
• Actual Primary Completion Date: June 30, 2022
• Actual Study Completion Date: June 30, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arm 1; school + asthma education + home environment remediation	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.
Experimental: Arm 2; asthma education + home environment remediation	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.
Active Comparator: Arm 3; enhanced standard of care	Behavioral: Informational mail; Family will be mailed publicly available asthma information every 3 months.

Outcome Measures

Primary Outcome Measures :

1. Health care utilization [ Time Frame: Baseline to 18 months ]
   Self-reported and from billing systems/insurance reports of frequency of emergency department 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 :

1. Medication usage [ Time Frame: Baseline to 18 months ]
   Refill data for each prescribed asthma medication will be used.
2. School absences [ Time Frame: Baseline to 18 months ]
   Self-reported missed school days due to asthma
3. Asthma control [ Time Frame: Baseline to 18 months ]
   Self-reported childhood asthma control test, which measures the frequency of daytime and nighttime asthma symptoms, activity limitations, and perception of disease control.
4. Asthma symptoms [ Time Frame: Baseline to 18 months ]
   Caregivers will report number of symptom free days in the last 7 days.
5. Child quality of life [ Time Frame: Baseline to 18 months ]
   Children will complete a measure that assesses their level of quality of life related to child asthma.
6. Parent quality of life [ Time Frame: Baseline to 18 months ]
   Parents will complete a measure that assesses their level of quality of life related to child asthma.

Eligibility Criteria

• Ages Eligible for Study: 5 Years to 11 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

United States, Virginia

Virginia Commonwealth University

Richmond, Virginia, United States, 23298

Sponsors and Collaborators

Virginia Commonwealth University

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Robin Everhart, PhD; Virginia Commonwealth University

  Study Documents (Full-Text)

Documents provided by Virginia Commonwealth University:

Informed Consent Form  [PDF] October 7, 2019

More Information

• Responsible Party: Virginia Commonwealth University
• ClinicalTrials.gov Identifier: NCT03297645
• Other Study ID Numbers: HM20010240; U01HL138682 ( U.S. NIH Grant/Contract )
• First Posted: September 29, 2017
• Last Update Posted: July 6, 2022
• Last Verified: June 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Shared data will be free of identifiers that could link findings with research participants or lead to deductive disclosure of individual subjects.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Analytic Code
• Time Frame: After the grant period has ended, data have been de-identified, and major study hypotheses have been tested.
• Access Criteria: Researchers should contact the study PI.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases