search
Back to results

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

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
School
Asthma education
Home environmental remediation
Informational mail
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma

Eligibility Criteria

5 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

school + asthma education + home environment remediation

asthma education + home environment remediation

enhanced standard of care

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Child Controller Medication
Prescription for a controller medication (caregiver report)
Child Asthma Action Plan
Caregivers reported whether their child had an updated asthma action plan for their child.
Child Asthma Control
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.
Child Asthma Symptoms
Caregivers report number of days in the last 7 days that their child had asthma symptoms.
Child Quality of Life
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.
Caregiver Quality of Life
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.

Full Information

First Posted
September 8, 2017
Last Updated
September 12, 2023
Sponsor
Virginia Commonwealth University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
search

1. Study Identification

Unique Protocol Identification Number
NCT03297645
Brief Title
RVA Breathes: A Richmond City Collaboration to Reduce Pediatric Asthma Disparities
Official Title
RVA Breathes: A Richmond City Collaboration to Reduce Pediatric Asthma Disparities
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 31, 2018 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
school + asthma education + home environment remediation
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
asthma education + home environment remediation
Arm Title
Arm 3
Arm Type
Active Comparator
Arm Description
enhanced standard of care
Intervention Type
Behavioral
Intervention Name(s)
School
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Asthma education
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Home environmental remediation
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Informational mail
Intervention Description
Family will be mailed publicly available asthma information every 3 months.
Primary Outcome Measure Information:
Title
Child Health Care Utilization
Description
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.
Time Frame
Child ED visits and hospitalizations in the last 9 months (from end of intervention/control phase to 9 month follow-up assessment)
Secondary Outcome Measure Information:
Title
Child Controller Medication
Description
Prescription for a controller medication (caregiver report)
Time Frame
Reported by caregiver at 9 month follow-up assessment
Title
Child Asthma Action Plan
Description
Caregivers reported whether their child had an updated asthma action plan for their child.
Time Frame
Reported by caregiver at 9 month follow-up assessment
Title
Child Asthma Control
Description
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.
Time Frame
Reported for child at 9 month follow-up assessment
Title
Child Asthma Symptoms
Description
Caregivers report number of days in the last 7 days that their child had asthma symptoms.
Time Frame
Reported by caregiver at 9 month follow-up assessment
Title
Child Quality of Life
Description
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.
Time Frame
Reported by child at 9 month follow-up assessment
Title
Caregiver Quality of Life
Description
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.
Time Frame
Reported by caregivers at 9 month follow-up assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin Everhart, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Shared data will be free of identifiers that could link findings with research participants or lead to deductive disclosure of individual subjects.
IPD Sharing Time Frame
After the grant period has ended, data have been de-identified, and major study hypotheses have been tested.
IPD Sharing Access Criteria
Researchers should contact the study PI.

Learn more about this trial

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

We'll reach out to this number within 24 hrs