Trial Outcomes & Findings for RVA Breathes: A Richmond City Collaboration to Reduce Pediatric Asthma Disparities (NCT NCT03297645)

NCT ID: NCT03297645

Last Updated: 2023-10-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

500 participants

Primary outcome timeframe

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

Results posted on

2023-10-06

Participant Flow

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.

Participant milestones

Participant milestones
Measure
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.
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.
Control
enhanced standard of care Informational mail: Family will be mailed publicly available asthma information every 3 months.
Overall Study
STARTED
118
69
63
Overall Study
COMPLETED
81
51
54
Overall Study
NOT COMPLETED
37
18
9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Full Intervention
n=236 Participants
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.
Intervention Without School
n=138 Participants
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.
Control
n=126 Participants
enhanced standard of care Informational mail: Family will be mailed publicly available asthma information every 3 months.
Total
n=500 Participants
Total of all reporting groups
Age, Categorical
Demographics · <=18 years
118 Participants
n=5 Participants
69 Participants
n=7 Participants
63 Participants
n=5 Participants
250 Participants
n=4 Participants
Age, Categorical
Demographics · Between 18 and 65 years
118 Participants
n=5 Participants
69 Participants
n=7 Participants
63 Participants
n=5 Participants
250 Participants
n=4 Participants
Age, Categorical
Demographics · >=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Sex: Female, Male
Demographics · Female
159 Participants
n=5 Participants
102 Participants
n=7 Participants
83 Participants
n=5 Participants
344 Participants
n=4 Participants
Sex: Female, Male
Demographics · Male
77 Participants
n=5 Participants
36 Participants
n=7 Participants
43 Participants
n=5 Participants
156 Participants
n=4 Participants
Race/Ethnicity, Customized
Child - White
1 Participants
n=5 Participants
2 Participants
n=7 Participants
0 Participants
n=5 Participants
3 Participants
n=4 Participants
Race/Ethnicity, Customized
Child - African American/Black
94 Participants
n=5 Participants
55 Participants
n=7 Participants
46 Participants
n=5 Participants
195 Participants
n=4 Participants
Race/Ethnicity, Customized
Child - Latinx
9 Participants
n=5 Participants
5 Participants
n=7 Participants
8 Participants
n=5 Participants
22 Participants
n=4 Participants
Race/Ethnicity, Customized
Child - Mixed/Multiple
12 Participants
n=5 Participants
7 Participants
n=7 Participants
9 Participants
n=5 Participants
28 Participants
n=4 Participants
Race/Ethnicity, Customized
Child - Other
2 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
2 Participants
n=4 Participants
Race/Ethnicity, Customized
Caregiver - White
5 Participants
n=5 Participants
2 Participants
n=7 Participants
3 Participants
n=5 Participants
10 Participants
n=4 Participants
Race/Ethnicity, Customized
Caregiver - African American/Black
96 Participants
n=5 Participants
58 Participants
n=7 Participants
47 Participants
n=5 Participants
201 Participants
n=4 Participants
Race/Ethnicity, Customized
Caregiver - Latinx
9 Participants
n=5 Participants
6 Participants
n=7 Participants
8 Participants
n=5 Participants
23 Participants
n=4 Participants
Race/Ethnicity, Customized
Caregiver - Mixed/Multiple
5 Participants
n=5 Participants
3 Participants
n=7 Participants
4 Participants
n=5 Participants
12 Participants
n=4 Participants
Race/Ethnicity, Customized
Caregiver - Other
3 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
4 Participants
n=4 Participants
Region of Enrollment
United States
236 Participants
n=5 Participants
138 Participants
n=7 Participants
126 Participants
n=5 Participants
500 Participants
n=4 Participants

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure
Full Intervention
n=68 Participants
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.
Intervention Without School
n=38 Participants
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.
Control
n=36 Participants
enhanced standard of care Informational mail: Family will be mailed publicly available asthma information every 3 months.
Child Health Care Utilization
.0023 ED visits and hospitalizations
Standard Deviation .0005
.0032 ED visits and hospitalizations
Standard Deviation .0009
.0021 ED visits and hospitalizations
Standard Deviation .0008

SECONDARY outcome

Timeframe: Reported by caregiver at 9 month follow-up assessment

Population: Outcome data for children

Prescription for a controller medication (caregiver report)

Outcome measures

Outcome measures
Measure
Full Intervention
n=68 Participants
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.
Intervention Without School
n=36 Participants
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.
Control
n=41 Participants
enhanced standard of care Informational mail: Family will be mailed publicly available asthma information every 3 months.
Child Controller Medication
32 Participants
23 Participants
17 Participants

SECONDARY outcome

Timeframe: Reported by caregiver at 9 month follow-up assessment

Population: Outcome data for children

Caregivers reported whether their child had an updated asthma action plan for their child.

Outcome measures

Outcome measures
Measure
Full Intervention
n=66 Participants
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.
Intervention Without School
n=36 Participants
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.
Control
n=41 Participants
enhanced standard of care Informational mail: Family will be mailed publicly available asthma information every 3 months.
Child Asthma Action Plan
53 Participants
29 Participants
30 Participants

SECONDARY outcome

Timeframe: Reported for child at 9 month follow-up assessment

Population: Outcome data for children

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.

Outcome measures

Outcome measures
Measure
Full Intervention
n=76 Participants
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.
Intervention Without School
n=45 Participants
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.
Control
n=45 Participants
enhanced standard of care Informational mail: Family will be mailed publicly available asthma information every 3 months.
Child Asthma Control
21.08 units on a scale
Standard Deviation 4.32
20.69 units on a scale
Standard Deviation 5.06
20.58 units on a scale
Standard Deviation 3.81

SECONDARY outcome

Timeframe: Reported by caregiver at 9 month follow-up assessment

Population: Outcome data for children

Caregivers report number of days in the last 7 days that their child had asthma symptoms.

Outcome measures

Outcome measures
Measure
Full Intervention
n=67 Participants
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.
Intervention Without School
n=44 Participants
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.
Control
n=42 Participants
enhanced standard of care Informational mail: Family will be mailed publicly available asthma information every 3 months.
Child Asthma Symptoms
.93 days
Standard Deviation 1.62
1.09 days
Standard Deviation 1.74
.86 days
Standard Deviation 1.05

SECONDARY outcome

Timeframe: Reported by child at 9 month follow-up assessment

Population: Outcome data for children

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.

Outcome measures

Outcome measures
Measure
Full Intervention
n=51 Participants
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.
Intervention Without School
n=20 Participants
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.
Control
n=22 Participants
enhanced standard of care Informational mail: Family will be mailed publicly available asthma information every 3 months.
Child Quality of Life
4.95 units on a scale
Standard Deviation 1.84
4.98 units on a scale
Standard Deviation 1.76
5.62 units on a scale
Standard Deviation 1.67

SECONDARY outcome

Timeframe: Reported by caregivers at 9 month follow-up assessment

Population: Outcome data for caregivers

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.

Outcome measures

Outcome measures
Measure
Full Intervention
n=75 Participants
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.
Intervention Without School
n=44 Participants
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.
Control
n=42 Participants
enhanced standard of care Informational mail: Family will be mailed publicly available asthma information every 3 months.
Caregiver Quality of Life
6.10 units on a scale
Standard Deviation 1.23
6.40 units on a scale
Standard Deviation .70
6.26 units on a scale
Standard Deviation .88

Adverse Events

Full Intervention

Serious events: 3 serious events
Other events: 49 other events
Deaths: 0 deaths

Intervention Without School

Serious events: 6 serious events
Other events: 20 other events
Deaths: 0 deaths

Control

Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Full Intervention
n=118 participants at risk
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.
Intervention Without School
n=69 participants at risk
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.
Control
n=63 participants at risk
enhanced standard of care Informational mail: Family will be mailed publicly available asthma information every 3 months.
Respiratory, thoracic and mediastinal disorders
Child hospitalization due to asthma
2.5%
3/118 • Across 18 month study participation
Adverse event collection was for child participants only and was reported by caregivers or gathered from health records. Caregivers were not monitored for adverse events.
7.2%
5/69 • Across 18 month study participation
Adverse event collection was for child participants only and was reported by caregivers or gathered from health records. Caregivers were not monitored for adverse events.
3.2%
2/63 • Across 18 month study participation
Adverse event collection was for child participants only and was reported by caregivers or gathered from health records. Caregivers were not monitored for adverse events.
Blood and lymphatic system disorders
Child cancer diagnosis
0.00%
0/118 • Across 18 month study participation
Adverse event collection was for child participants only and was reported by caregivers or gathered from health records. Caregivers were not monitored for adverse events.
1.4%
1/69 • Across 18 month study participation
Adverse event collection was for child participants only and was reported by caregivers or gathered from health records. Caregivers were not monitored for adverse events.
0.00%
0/63 • Across 18 month study participation
Adverse event collection was for child participants only and was reported by caregivers or gathered from health records. Caregivers were not monitored for adverse events.

Other adverse events

Other adverse events
Measure
Full Intervention
n=118 participants at risk
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.
Intervention Without School
n=69 participants at risk
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.
Control
n=63 participants at risk
enhanced standard of care Informational mail: Family will be mailed publicly available asthma information every 3 months.
Respiratory, thoracic and mediastinal disorders
Child emergency department visit due to asthma
40.7%
48/118 • Across 18 month study participation
Adverse event collection was for child participants only and was reported by caregivers or gathered from health records. Caregivers were not monitored for adverse events.
27.5%
19/69 • Across 18 month study participation
Adverse event collection was for child participants only and was reported by caregivers or gathered from health records. Caregivers were not monitored for adverse events.
30.2%
19/63 • Across 18 month study participation
Adverse event collection was for child participants only and was reported by caregivers or gathered from health records. Caregivers were not monitored for adverse events.
Skin and subcutaneous tissue disorders
Child rash
0.85%
1/118 • Across 18 month study participation
Adverse event collection was for child participants only and was reported by caregivers or gathered from health records. Caregivers were not monitored for adverse events.
1.4%
1/69 • Across 18 month study participation
Adverse event collection was for child participants only and was reported by caregivers or gathered from health records. Caregivers were not monitored for adverse events.
0.00%
0/63 • Across 18 month study participation
Adverse event collection was for child participants only and was reported by caregivers or gathered from health records. Caregivers were not monitored for adverse events.

Additional Information

Robin S. Everhart, PhD

Virginia Commonwealth University

Phone: (804) 828-7249

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place