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

NCT03297645 | Completed Results DMC

• 2 other identifiers: HM20010240U01HL138682
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Child Health Care Utilization

  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.

  Child ED visits and hospitalizations in the last 9 months (from end of intervention/control phase to 9 month follow-up assessment)

Secondary Outcomes (6)

• Child Controller Medication

  Reported by caregiver at 9 month follow-up assessment

• Child Asthma Action Plan

  Reported by caregiver at 9 month follow-up assessment

• Child Asthma Control

  Reported for child at 9 month follow-up assessment

• Child Asthma Symptoms

  Reported by caregiver at 9 month follow-up assessment

• Child Quality of Life

  Reported by child at 9 month follow-up assessment

Study Arms (3)

Arm 1

EXPERIMENTAL

school + asthma education + home environment remediation

Behavioral: School; Behavioral: Asthma education; Behavioral: Home environmental remediation

Arm 2

EXPERIMENTAL

asthma education + home environment remediation

Behavioral: Asthma education; Behavioral: Home environmental remediation

Arm 3

ACTIVE COMPARATOR

enhanced standard of care

Behavioral: Informational mail

Interventions

School BEHAVIORAL

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.

Arm 1

Asthma education BEHAVIORAL

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.

Arm 1; Arm 2

Home environmental remediation BEHAVIORAL

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.

Arm 1; Arm 2

Informational mail BEHAVIORAL

Family will be mailed publicly available asthma information every 3 months.

Arm 3

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Enrolled in Richmond Public Schools
• Asthma-related emergency department visit/hospitalization within last year
• Physician-diagnosed asthma
• Richmond city resident

You may not qualify if:

• Severe medical or psychiatric condition (child or caregiver)

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Schools

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Non-Medical Public and Private Facilities

Results Point of Contact

• Title: Robin S. Everhart, PhD
• Organization: Virginia Commonwealth University

reverhart@vcu.edu

(804) 828-7249

Study Officials

• Robin Everhart, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2017
• First Posted: September 29, 2017
• Study Start: May 31, 2018
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: October 6, 2023
• Results First Posted: October 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

US (1)