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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03297645
Recruitment Status : Recruiting
First Posted : September 29, 2017
Last Update Posted : June 14, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
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.

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 12 months and complete follow-up assessments (post-treatment and 3-, 6-, and 12-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 12 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 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
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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.




Primary Outcome Measures :
  1. Health care utilization [ Time Frame: Baseline to 24 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 24 months ]
    Refill data for each prescribed asthma medication will be used.

  2. School absences [ Time Frame: Baseline to 24 months ]
    Self-reported missed school days due to asthma

  3. Asthma control [ Time Frame: Baseline to 24 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 24 months ]
    Caregivers will report number of symptom free days in the last 7 days.

  5. Child quality of life [ Time Frame: Baseline to 24 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 24 months ]
    Parents will complete a measure that assesses their level of quality of life related to child asthma.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03297645


Contacts
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Contact: Robin Everhart, PhD (804) 828-7249 reverhart@vcu.edu

Locations
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United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Robin Everhart, PhD    804-828-7249    reverhart@vcu.edu   
Sponsors and Collaborators
Virginia Commonwealth University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Robin Everhart, PhD Virginia Commonwealth University
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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    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases