Asthma
Conditions
Keywords
Asthma
Brief summary
Asthma is the most common chronic illness of childhood, and hospitalization rates are increasing. In the US, impoverished children and children from minority ethnic and racial backgrounds suffer disproportionately from asthma. While National Heart, Lung, and Blood Institute (NHLBI) guidelines recommend daily preventive medications for all children with mild persistent to severe persistent asthma, studies indicate that many children in the US who should receive preventive medications are not receiving them. The overall goal of this project is to target an ethnically diverse population of inner-city schoolchildren with asthma and explore a school-based program to reduce asthma morbidity. We hypothesize that children receiving a comprehensive school-based intervention will experience less asthma-related morbidity compared to children receiving usual care. Our comprehensive school-based intervention consists of both administration of recommended preventive asthma medications in school (with dose adjustments according to NHLBI guidelines) and an environmental tobacco smoke (ETS) reduction program in the home for smoke-exposed children. Our secondary hypothesis is that, among the subgroup of smoke-exposed children, those who receive the school-based intervention with ETS reduction will experience less asthma morbidity than those who receive usual care.
Interventions
BEHAVIORALSchool-based Care
The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Halcyon Hill Foundation
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 10 Years
Healthy volunteers
No
Inclusion criteria
* Physician-diagnosed asthma * Mild persistent to severe persistent asthma * Ages 3-10 years * Attending school in the Rochester City School District preschools or elementary schools * Signed physician permission to enroll the child * Parent or caregiver must consent to the intervention
Exclusion criteria
* Inability to speak and understand either English or Spanish * No access to a working phone for follow-up surveys * The family planning to leave the school district within fewer than 6 months * The child having other significant medical conditions that could interfere with the assessment of asthma-related outcome measures * children in foster care or other situations in which consent cannot be obtained from a guardian * Current participation in other local asthma interventions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Symptom Free Days | Average Symptom Free Days, over 2 weeks, during peak asthma season (November-February) | The primary outcome variable is the average number of symptom free days over 2 weeks assessed during peak asthma season (data collected during November, December, January and February during the school year). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cotinine Level | 2 month and approximately 9 month (end of school year) follow-up assessments | To test the effectiveness of the environmental tobacco smoke (ETS) reduction portion of the study, we will compare baseline cotinine values to 2 month (for smoke exposed participants) and final follow-up assessments (for all participants). |
| Cost Effectiveness of the Intervention | approximately 9 months (length of school year) | Cost-effectiveness will examine the net program costs to the number of symptom-free days gained. Benefits will be described as the net difference in medical and productivity costs between children in the treatment and control groups. |
| Additional Asthma Morbidity Outcomes | 1-9 months (Monthly Follow-up assessments) | We will look at additional asthma morbidity outcomes including symptom nights, days needing rescue medications, functional severity, days absent from school, and quality of life. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Usual asthma care | 265 |
| School-based Care The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers). | 265 |
| Total | 530 |
Baseline characteristics
| Characteristic | School-based Care | Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 265 Participants | 265 Participants | 530 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 7.1 years STANDARD_DEVIATION 2 | 7.2 years STANDARD_DEVIATION 1.9 | 7.1 years STANDARD_DEVIATION 1.9 |
| Region of Enrollment United States | 265 participants | 265 participants | 530 participants |
| Sex: Female, Male Female | 104 Participants | 118 Participants | 222 Participants |
| Sex: Female, Male Male | 161 Participants | 147 Participants | 308 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 265 | 0 / 265 |
| serious Total, serious adverse events | 0 / 265 | 0 / 265 |
Outcome results
Primary
Number of Symptom Free Days
The primary outcome variable is the average number of symptom free days over 2 weeks assessed during peak asthma season (data collected during November, December, January and February during the school year).
Time frame: Average Symptom Free Days, over 2 weeks, during peak asthma season (November-February)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Number of Symptom Free Days | 10.7 Days | Standard Deviation 3.1 |
| School-based Care | Number of Symptom Free Days | 11.6 Days | Standard Deviation 2.5 |
Secondary
Additional Asthma Morbidity Outcomes
We will look at additional asthma morbidity outcomes including symptom nights, days needing rescue medications, functional severity, days absent from school, and quality of life.
Time frame: 1-9 months (Monthly Follow-up assessments)
Secondary
Cost Effectiveness of the Intervention
Cost-effectiveness will examine the net program costs to the number of symptom-free days gained. Benefits will be described as the net difference in medical and productivity costs between children in the treatment and control groups.
Time frame: approximately 9 months (length of school year)
Secondary
Cotinine Level
To test the effectiveness of the environmental tobacco smoke (ETS) reduction portion of the study, we will compare baseline cotinine values to 2 month (for smoke exposed participants) and final follow-up assessments (for all participants).
Time frame: 2 month and approximately 9 month (end of school year) follow-up assessments