Asthma
Conditions
Keywords
Asthma, Preschool, Health Disparities, Implementation
Brief summary
Low-income, minority children are disproportionately affected by asthma and can experience higher rates of asthma attacks, lower lung function, decreased physical activity, increases in school absenteeism, and higher rates of death. The National Center for Children in Poverty suggests that effective interventions to improve asthma and reduce harm for high risk groups (like low-income minority children) must begin in early childhood. Previous research has shown that asthma education programs can be effective to improve overall asthma management in preschool children, but there has been limited sustainability of these programs in medical, educational, and social environments that serve young high risk children. One of the core missions of federally-funded Head Start programs is to provide preventive health services and screening to their low-income preschool students and would be an ideal setting in the community to disseminate an early asthma education program. The purpose of this study is to draw on our health and research partnership with Baltimore City Head Start programs to test the effectiveness of a home-based asthma education intervention combined with a Head Start level asthma education program compared to a Head Start level asthma education program alone.
Detailed description
Despite advances in asthma therapies and the wide-spread dissemination of asthma clinical guidelines, low-income, minority children have disproportionately high morbidity and mortality from asthma. The National Center for Children in Poverty has strongly argued that effective interventions to improve asthma health disparities and reduce harm must begin in early childhood. Previous efficacy studies have suggested that asthma education programs can be effective in improving overall management of asthma for preschool children. However, for these promising asthma intervention strategies to have sustainable public health impact for low-income, minority children they must be integrated within those medical, educational and social structures that serve these young high risk children, such as community clinics, schools and day care programs. Because one of the core missions of federally-funded Head Start programs is to provide preventive health services and screening to their low-income preschool students, Head Start represents an ideal community setting for disseminating early asthma education. The investigators propose to draw on our established health and research partnership with Head Start programs in Baltimore City to test the effectiveness of this home-based asthma education intervention with demonstrated efficacy, when delivered in the context of a Head Start-wide asthma education program. The investigators further propose to partner with Head Start to support and evaluate adoption, maintenance and dissemination of new knowledge gained from this project. Specifically the investigators hypothesize that participants receiving the ABC intervention combined with a HS-level asthma education will have more symptom free days at the 6-, 9-, and 12-month evaluation when compared with participants in the HS-level asthma education alone. The investigators plan to enroll of 406 children age 2-6 years old enrolled in Head Start with symptomatic asthma. Secondary outcome measures include other measures of asthma morbidity (i.e., hospitalizations, Emergency Department visits, oral steroid bursts, school absences, and caregiver quality of life). The investigators will also evaluate the mediating effects of outcomes expectancies, self-efficacy, asthma knowledge, motivation, and asthma management practices, as well as moderator effects, such as health literacy, caregiver depression, neighborhood cohesion, family management of asthma, and Head Start adoption and dissemination of an asthma education curriculum.
Interventions
4 home based and 3 phone based sessions with community asthma outreach worker to provide families with asthma education
Sponsors
Study design
Eligibility
Inclusion criteria
* Enrolled in Head Start * Physician diagnosed asthma or reactive airway disease * Resides in Baltimore City or Baltimore County * English Speaking
Exclusion criteria
* Enrolled in another pulmonary research study * Sibling enrolled in study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Control as Determined by Test for Respiratory and Asthma Control in Kids Assessment Tool | Baseline, 3, 6, 9 and 12 months | The Test for Respiratory and Asthma Control in Kids test is an assessment tool consisting of 5 questions posed to caregivers and designed to assess respiratory and asthma control in patients between 12 months and 5 years. It addresses risk and impairment domains outlined in the Asthma Guidelines and is meant to be interpreted by medical professionals. A total score is calculated from 0-100 with scores less than 80 indicating the child's asthma may not be under control and scores of 80 or more indicating that a child's asthma seems to be under control. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Emergency Department (ED) Visits [Child] | Baseline, 3, 6, 9 and 12 months | Aggregate number of ED visits for asthma in past 90 days for all participants. |
| Total Number of Hospitalizations [Child] | Baseline and 12 months | Aggregate number of hospitalizations due to asthma 12 months before randomization vs after randomization for all participants. |
Countries
United States
Participant flow
Pre-assignment details
2 refused to complete a baseline assessment after consent 1 participant dropped due to no asthma after consent 3 families were pilot participants and their data is not represented in final outcomes except in sponsor reporting
Participants by arm
| Arm | Count |
|---|---|
| Home Based Asthma Education This arm consists of caregiver and child pairs. Caregiver is consented and is asked questions relating to the child's health due to young age of child.
For those randomly assigned to the Home Based Asthma Education Arm- the consented caregiver received 4 home based and 3 phone based asthma education sessions with a community asthma outreach worker. Due to age of child, primary asthma management is provided by the caregiver, so intervention was delivered directly to caregiver. | 199 |
| Control This arm consists of caregiver and child pairs. Caregiver is consented and is asked questions relating to the child's health due to young age of child.
Caregiver is not provided a control arm specific intervention. | 199 |
| Total | 398 |
Baseline characteristics
| Characteristic | Home Based Asthma Education | Total | Control |
|---|---|---|---|
| Age, Categorical Caregiver in caregiver-child pair <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Caregiver in caregiver-child pair >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Caregiver in caregiver-child pair Between 18 and 65 years | 199 Participants | 397 Participants | 198 Participants |
| Age, Categorical Child in caregiver-child pair <=18 years | 199 Participants | 398 Participants | 199 Participants |
| Age, Categorical Child in caregiver-child pair >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Child in caregiver-child pair Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous Caregiver in caregiver-child pair | 30.9 years STANDARD_DEVIATION 7.8 | 31.4 years STANDARD_DEVIATION 8.4 | 31.9 years STANDARD_DEVIATION 8.9 |
| Age, Continuous Child in caregiver-child pair | 4.2 years STANDARD_DEVIATION 0.6 | 4.2 years STANDARD_DEVIATION 0.7 | 4.2 years STANDARD_DEVIATION 0.8 |
| Ethnicity (NIH/OMB) Child in caregiver-child pair Hispanic or Latino | 6 Participants | 14 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Child in caregiver-child pair Not Hispanic or Latino | 193 Participants | 384 Participants | 191 Participants |
| Ethnicity (NIH/OMB) Child in caregiver-child pair Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Child in caregiver-child pair American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Child in caregiver-child pair Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Child in caregiver-child pair Black or African American | 189 Participants | 379 Participants | 190 Participants |
| Race (NIH/OMB) Child in caregiver-child pair More than one race | 2 Participants | 7 Participants | 5 Participants |
| Race (NIH/OMB) Child in caregiver-child pair Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Child in caregiver-child pair Unknown or Not Reported | 4 Participants | 4 Participants | 0 Participants |
| Race (NIH/OMB) Child in caregiver-child pair White | 4 Participants | 8 Participants | 4 Participants |
| Region of Enrollment United States | 199 Participants | 398 Participants | 199 Participants |
| Sex: Female, Male Caregiver in caregiver-child pair Female | 184 Participants | 371 Participants | 187 Participants |
| Sex: Female, Male Caregiver in caregiver-child pair Male | 15 Participants | 27 Participants | 12 Participants |
| Sex: Female, Male Child in caregiver-child pair Female | 76 Participants | 151 Participants | 75 Participants |
| Sex: Female, Male Child in caregiver-child pair Male | 123 Participants | 247 Participants | 124 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 398 | 0 / 398 |
| other Total, other adverse events | 2 / 398 | 0 / 398 |
| serious Total, serious adverse events | 8 / 398 | 16 / 398 |
Outcome results
Asthma Control as Determined by Test for Respiratory and Asthma Control in Kids Assessment Tool
The Test for Respiratory and Asthma Control in Kids test is an assessment tool consisting of 5 questions posed to caregivers and designed to assess respiratory and asthma control in patients between 12 months and 5 years. It addresses risk and impairment domains outlined in the Asthma Guidelines and is meant to be interpreted by medical professionals. A total score is calculated from 0-100 with scores less than 80 indicating the child's asthma may not be under control and scores of 80 or more indicating that a child's asthma seems to be under control.
Time frame: Baseline, 3, 6, 9 and 12 months
Population: Participants analyzed represent children with asthma enrolled in the protocol as caregiver-child pairs. Number analyzed per row vary since some families were unable to be contacted for specific assessment time points, but were able to be contacted for future assessments.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Home Based Asthma Education | Asthma Control as Determined by Test for Respiratory and Asthma Control in Kids Assessment Tool | 3 months | 85 score on a scale |
| Home Based Asthma Education | Asthma Control as Determined by Test for Respiratory and Asthma Control in Kids Assessment Tool | 9 months | 85 score on a scale |
| Home Based Asthma Education | Asthma Control as Determined by Test for Respiratory and Asthma Control in Kids Assessment Tool | 6 months | 85 score on a scale |
| Home Based Asthma Education | Asthma Control as Determined by Test for Respiratory and Asthma Control in Kids Assessment Tool | 12 months | 85 score on a scale |
| Home Based Asthma Education | Asthma Control as Determined by Test for Respiratory and Asthma Control in Kids Assessment Tool | Baseline | 70 score on a scale |
| Control | Asthma Control as Determined by Test for Respiratory and Asthma Control in Kids Assessment Tool | 12 months | 85 score on a scale |
| Control | Asthma Control as Determined by Test for Respiratory and Asthma Control in Kids Assessment Tool | Baseline | 75 score on a scale |
| Control | Asthma Control as Determined by Test for Respiratory and Asthma Control in Kids Assessment Tool | 3 months | 80 score on a scale |
| Control | Asthma Control as Determined by Test for Respiratory and Asthma Control in Kids Assessment Tool | 6 months | 85 score on a scale |
| Control | Asthma Control as Determined by Test for Respiratory and Asthma Control in Kids Assessment Tool | 9 months | 85 score on a scale |
Total Number of Emergency Department (ED) Visits [Child]
Aggregate number of ED visits for asthma in past 90 days for all participants.
Time frame: Baseline, 3, 6, 9 and 12 months
Population: Participants analyzed represent children with asthma enrolled in the protocol as caregiver-child pairs. Number analyzed per row vary since some families were unable to be contacted for specific assessment time points, but were able to be contacted for future assessments.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Home Based Asthma Education | Total Number of Emergency Department (ED) Visits [Child] | 3 months | 34 ED visits |
| Home Based Asthma Education | Total Number of Emergency Department (ED) Visits [Child] | 9 months | 37 ED visits |
| Home Based Asthma Education | Total Number of Emergency Department (ED) Visits [Child] | 6 months | 28 ED visits |
| Home Based Asthma Education | Total Number of Emergency Department (ED) Visits [Child] | 12 months | 31 ED visits |
| Home Based Asthma Education | Total Number of Emergency Department (ED) Visits [Child] | Baseline | 65 ED visits |
| Control | Total Number of Emergency Department (ED) Visits [Child] | 12 months | 35 ED visits |
| Control | Total Number of Emergency Department (ED) Visits [Child] | Baseline | 50 ED visits |
| Control | Total Number of Emergency Department (ED) Visits [Child] | 3 months | 42 ED visits |
| Control | Total Number of Emergency Department (ED) Visits [Child] | 6 months | 32 ED visits |
| Control | Total Number of Emergency Department (ED) Visits [Child] | 9 months | 38 ED visits |
Total Number of Hospitalizations [Child]
Aggregate number of hospitalizations due to asthma 12 months before randomization vs after randomization for all participants.
Time frame: Baseline and 12 months
Population: Participants analyzed represent children with asthma enrolled in the protocol as caregiver-child pairs. Number analyzed per row vary since some families were unable to be contacted for specific assessment time points, but were able to be contacted for future assessments.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Home Based Asthma Education | Total Number of Hospitalizations [Child] | Baseline | 6 asthma related hospitalizations |
| Home Based Asthma Education | Total Number of Hospitalizations [Child] | 12 months | 7 asthma related hospitalizations |
| Control | Total Number of Hospitalizations [Child] | Baseline | 10 asthma related hospitalizations |
| Control | Total Number of Hospitalizations [Child] | 12 months | 24 asthma related hospitalizations |