Asthma
Conditions
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.
Interventions
BEHAVIORALSchool
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.
BEHAVIORALAsthma 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.
BEHAVIORALHome 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.
BEHAVIORALInformational mail
Family will be mailed publicly available asthma information every 3 months.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 11 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Child Health Care Utilization | Child ED visits and hospitalizations in the last 9 months (from end of intervention/control phase to 9 month follow-up assessment) | 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
| Measure | Time frame | Description |
|---|---|---|
| Child Asthma Action Plan | Reported by caregiver at 9 month follow-up assessment | Caregivers reported whether their child had an updated asthma action plan for their child. |
| Child Asthma Control | Reported for child at 9 month follow-up assessment | 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 Controller Medication | Reported by caregiver at 9 month follow-up assessment | Prescription for a controller medication (caregiver report) |
| Child Quality of Life | Reported by child at 9 month follow-up assessment | 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 | Reported by caregivers at 9 month follow-up assessment | 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. |
| Child Asthma Symptoms | Reported by caregiver at 9 month follow-up assessment | Caregivers report number of days in the last 7 days that their child had asthma symptoms. |
Countries
United States
Participant flow
Pre-assignment details
Caregiver-child dyads were enrolled. The numbers represented in the participant flowchart reflect the number of caregiver and child dyads. For the full intervention, 236 unique participants started, 162 completed and 74 did not complete. For the intervention without school, 138 unique participants started, 102 completed and 36 did not complete. For the control, 126 unique participants started, 108 completed and 18 did not complete.
Participants by arm
| Arm | Count |
|---|---|
| Full Intervention school + asthma education + home environment remediation
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.
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.
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. | 236 |
| Intervention Without School asthma education + home environment remediation
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.
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. | 138 |
| Control enhanced standard of care
Informational mail: Family will be mailed publicly available asthma information every 3 months. | 126 |
| Total | 500 |
Baseline characteristics
| Characteristic | Full Intervention | Intervention Without School | Control | Total |
|---|---|---|---|---|
| Age, Categorical Demographics <=18 years | 118 Participants | 69 Participants | 63 Participants | 250 Participants |
| Age, Categorical Demographics >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Demographics Between 18 and 65 years | 118 Participants | 69 Participants | 63 Participants | 250 Participants |
| Race/Ethnicity, Customized Caregiver - African American/Black | 96 Participants | 58 Participants | 47 Participants | 201 Participants |
| Race/Ethnicity, Customized Caregiver - Latinx | 9 Participants | 6 Participants | 8 Participants | 23 Participants |
| Race/Ethnicity, Customized Caregiver - Mixed/Multiple | 5 Participants | 3 Participants | 4 Participants | 12 Participants |
| Race/Ethnicity, Customized Caregiver - Other | 3 Participants | 0 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Caregiver - White | 5 Participants | 2 Participants | 3 Participants | 10 Participants |
| Race/Ethnicity, Customized Child - African American/Black | 94 Participants | 55 Participants | 46 Participants | 195 Participants |
| Race/Ethnicity, Customized Child - Latinx | 9 Participants | 5 Participants | 8 Participants | 22 Participants |
| Race/Ethnicity, Customized Child - Mixed/Multiple | 12 Participants | 7 Participants | 9 Participants | 28 Participants |
| Race/Ethnicity, Customized Child - Other | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Child - White | 1 Participants | 2 Participants | 0 Participants | 3 Participants |
| Region of Enrollment United States | 236 Participants | 138 Participants | 126 Participants | 500 Participants |
| Sex: Female, Male Demographics Female | 159 Participants | 102 Participants | 83 Participants | 344 Participants |
| Sex: Female, Male Demographics Male | 77 Participants | 36 Participants | 43 Participants | 156 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 118 | 0 / 69 | 0 / 63 |
| other Total, other adverse events | 49 / 118 | 20 / 69 | 19 / 63 |
| serious Total, serious adverse events | 3 / 118 | 6 / 69 | 2 / 63 |
Outcome results
Primary
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.
Time frame: Child ED visits and hospitalizations in the last 9 months (from end of intervention/control phase to 9 month follow-up assessment)
Population: Outcome data for children
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Full Intervention | Child Health Care Utilization | .0023 ED visits and hospitalizations | Standard Deviation 0.0005 |
| Intervention Without School | Child Health Care Utilization | .0032 ED visits and hospitalizations | Standard Deviation 0.0009 |
| Control | Child Health Care Utilization | .0021 ED visits and hospitalizations | Standard Deviation 0.0008 |
Secondary
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.
Time frame: Reported by caregivers at 9 month follow-up assessment
Population: Outcome data for caregivers
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Full Intervention | Caregiver Quality of Life | 6.10 units on a scale | Standard Deviation 1.23 |
| Intervention Without School | Caregiver Quality of Life | 6.40 units on a scale | Standard Deviation 0.7 |
| Control | Caregiver Quality of Life | 6.26 units on a scale | Standard Deviation 0.88 |
Secondary
Child Asthma Action Plan
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
Population: Outcome data for children
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Full Intervention | Child Asthma Action Plan | 53 Participants |
| Intervention Without School | Child Asthma Action Plan | 29 Participants |
| Control | Child Asthma Action Plan | 30 Participants |
Secondary
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.
Time frame: Reported for child at 9 month follow-up assessment
Population: Outcome data for children
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Full Intervention | Child Asthma Control | 21.08 units on a scale | Standard Deviation 4.32 |
| Intervention Without School | Child Asthma Control | 20.69 units on a scale | Standard Deviation 5.06 |
| Control | Child Asthma Control | 20.58 units on a scale | Standard Deviation 3.81 |
Secondary
Child Asthma Symptoms
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
Population: Outcome data for children
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Full Intervention | Child Asthma Symptoms | .93 days | Standard Deviation 1.62 |
| Intervention Without School | Child Asthma Symptoms | 1.09 days | Standard Deviation 1.74 |
| Control | Child Asthma Symptoms | .86 days | Standard Deviation 1.05 |
Secondary
Child Controller Medication
Prescription for a controller medication (caregiver report)
Time frame: Reported by caregiver at 9 month follow-up assessment
Population: Outcome data for children
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Full Intervention | Child Controller Medication | 32 Participants |
| Intervention Without School | Child Controller Medication | 23 Participants |
| Control | Child Controller Medication | 17 Participants |
Secondary
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.
Time frame: Reported by child at 9 month follow-up assessment
Population: Outcome data for children
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Full Intervention | Child Quality of Life | 4.95 units on a scale | Standard Deviation 1.84 |
| Intervention Without School | Child Quality of Life | 4.98 units on a scale | Standard Deviation 1.76 |
| Control | Child Quality of Life | 5.62 units on a scale | Standard Deviation 1.67 |