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

Sponsor
Virginia Commonwealth University (Other)
Overall Status
Completed
CT.gov ID
NCT03297645
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
250
1
3
49
5.1

Study Details

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
  • Behavioral: School
  • Behavioral: Asthma education
  • Behavioral: Home environmental remediation
  • Behavioral: Informational mail
N/A

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
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 :
Jun 30, 2022
Actual Study Completion Date :
Jun 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 [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 [Baseline to 18 months]

    Refill data for each prescribed asthma medication will be used.

  2. School absences [Baseline to 18 months]

    Self-reported missed school days due to asthma

  3. Asthma control [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 [Baseline to 18 months]

    Caregivers will report number of symptom free days in the last 7 days.

  5. Child quality of life [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 [Baseline to 18 months]

    Parents will complete a measure that assesses their level of quality of life related to child asthma.

Eligibility Criteria

Criteria

Ages Eligible for Study:
5 Years to 11 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Site City State Country Postal Code
1 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)

More Information

Publications

None provided.
Responsible Party:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT03297645
Other Study ID Numbers:
  • HM20010240
  • U01HL138682
First Posted:
Sep 29, 2017
Last Update Posted:
Jul 6, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 6, 2022