Asthma in Children, Medication Adherence
Conditions
Brief summary
Improving adherence to inhaled corticosteroids (ICS) medication in urban minority pediatric populations is a clinical and population health priority. Financial incentives have been shown as a compelling method to engage a high-risk asthma population in regular ICS use, but whether and how adherence can be maintained and lead to sustained high adherence trajectories is unknown.
Detailed description
Investigators propose to initially enroll 125 children into an initial 1-month run-in interval. Participants who successfully complete the run-in interval will be randomized into a six-month intervention with a six month follow-up period. Children will be ages 5-12, and must have two or more visits to any combination of the outpatient, Emergency Department (ED) or hospital setting in the past year for asthma exacerbations at Children's Hospital of Philadelphia (CHOP). The study intervention will include daily automated medication reminders (either via text message or push reminder), an app to track daily medication use, and nominal incentives to promote daily controller use. Inhaled controller medication adherence and rescue medication use will be measured using electronic monitors affixed to the inhalers. Factors associated with differential adherence will be assessed using surveys administered during enrollment, the experiment interval (months 1 through 3), the observation interval (months 4 through 6), and study completion (months 12-13). Efficacy outcomes will include change in parent-reported asthma control and mean adherence to ICS between study arms during the experiment interval, as well as the observation interval. Patients will be considered fully enrolled when they fulfill the requirements of the Run-in period (sensor data uploaded to research platform AND text message receipt confirmed by caregiver) and are subsequently randomized.
Interventions
OTHERNominal Financial Incentives
The nominal financial incentives will consist of fixed-ratio incentives for each inhaled corticosteroids (ICS) actuation (25 cents for children on 4 daily ICS doses and 50 cents for children on 2 daily doses), with a maximum of $1 per day.
OTHERDaily Adherence Reminders/Adherence Performance Feedback
Study participants will receive automated daily text message or push notification reminders and automated weekly feedback summarizing their adherence performance through Way to Health, a mobile health, electronic monitoring platform.
Sponsors
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Children's Hospital of Philadelphia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* Males or females age 5 to 12 years and their parent or legal guardian. * Caregiver has an app enabled cellular phone (i.e., smart phone) * Prescribed inhaled corticosteroid or corticosteroid/long acting beta agonist combination for daily use * At least 2 asthma exacerbations in the preceding year (Any combination of hospitalizations, ED visits, or outpatient visits where oral steroid courses were administered for asthma) * Parental/guardian permission (informed consent) and if appropriate, child assent.
Exclusion criteria
* Subjects prescribed a controller medication to which the electronic device cannot affix * Subjects in which the mobile app is not compatible with their smart phone model * Subjects with major developmental delays or disabilities * Subjects with comorbid chronic diagnoses that influence their asthma management such as cystic fibrosis, bronchopulmonary dysplasia, or cyanotic heart disease * Families with active Department of Human Services (DHS) involvement * Non-English speaking families * Parents/guardians or subjects whose medical team recommends against approaching for enrollment in a research study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted) | 6 months | Calculated as the mean daily proportion of prescribed doses taken by study month by study arm. Days that reflect \>1 were truncated to 1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence Trajectory | 6 months | Group-based trajectory modeling derived of adherence patterns - not reported by study arm. This secondary outcome was included in the event that there was no difference in adherence between study arms to help identify participant characteristics that were associated with different adherence patterns. The unit of measure is the percentage of participants that fall into each adherence category (low, medium, and high adherence) over a 6-month time period. |
| Changes in Child Asthma Control Tool (cACT) Score | months 2, 4,7, 12 | Assess the change in total cACT score or parental portion of the cACT from baseline to the second, third, fourth, and fifth study visits. The Child Asthma Control Tool (cACT) score ranges from 0 (poor control) to 27 (complete control) and was assessed at study visits 1 and 3 only. The parental portion of the cACT ranges from 0-15 and was assessed at all study visits. The greater the value, the better the control. The larger the difference (larger magnitude) of the value in the differences between the scores, the greater the improvement in controlling the child's asthma diagnosis. |
| Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 12 months | Calculate and compare the number of asthma-related emergency room visits, hospitalizations and oral steroid courses between study arms. |
| Healthcare Costs of Utilization | 12 months | Calculate the costs associated with emergency room utilization, hospital utilization and oral steroid course prescriptions between study arms. |
Countries
United States
Participant flow
Recruitment details
125 participants were initially enrolled into the 1 month study run-in period, in which they were needed to successfully (1) synchronize their electronic study sensor with the caregivers smartphone (via Bluetooth) and the Way to Health study platform (via wireless or cellular data) and (2) respond to an automated text message from the Way to Health study platform.
Pre-assignment details
19 participants did not successfully complete the run-in period and, thus, were not randomized. 106 study participants were randomized in a 2:1:2 schema. The caregiver-child dyad was one unit. If the caregiver withdrew from the study, the child also withdrew from the study. Medication adherence was only collected from the child, but caregivers were included in the dyad-language given that they were interacting with certain parts of the intervention employed.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: Incentives, Plus Reminders & Feedback (IRF) There will be a run-in period to determine eligibility for randomization and collect baseline adherence data (Month 0).
During the Experiment period (Months 1-3), Arm 1 will receive the IRF intervention.
During the Observation period (Months 4-6), all the arms will have continued daily ICS monitoring to assess enduring effects of each arm - no IRF.
Nominal Financial Incentives: The nominal financial incentives will consist of fixed-ratio incentives for each inhaled corticosteroids (ICS) actuation (25 cents for children on 4 daily ICS doses and 50 cents for children on 2 daily doses), with a maximum of $1 per day.
Daily Adherence Reminders/Adherence Performance Feedback: Study participants will receive automated daily text message or push notification reminders and automated weekly feedback summarizing their adherence performance through Way to Health, a mobile health, electronic monitoring platform. | 38 |
| Arm 2: Reminders & Feedback ONLY There will be a run-in period to determine eligibility for randomization and collect baseline adherence data (Month 0).
During the Experiment period (Months 1-3), Arm 2 will receive ONLY reminders and feedback, without nominal financial incentives.
During the Observation period (Months 4-6), all three arms will have continued daily ICS monitoring to assess enduring effects of each arm - no IRF.
Daily Adherence Reminders/Adherence Performance Feedback: Study participants will receive automated daily text message or push notification reminders and automated weekly feedback summarizing their adherence performance through Way to Health, a mobile health, electronic monitoring platform. | 21 |
| Arm 3 (Control) There will be a run-in period to determine eligibility for randomization and collect baseline adherence data (Month 0).
During the Experiment period (Months 1-3), Arm 3 will not receive any component of the IRF intervention.
During the Observation period (Months 4-6), all three arms will have continued daily ICS monitoring to assess enduring effects of each arm - no IRF. | 40 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 1 | 1 |
| Overall Study | Lost to follow-up and research burden | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Arm 1: Incentives, Plus Reminders & Feedback (IRF) | Arm 2: Reminders & Feedback ONLY | Arm 3 (Control) | Total |
|---|---|---|---|---|
| Age, Customized Child Age Group 5-7 years | 12 Participants | 10 Participants | 18 Participants | 40 Participants |
| Age, Customized Child Age Group 8-11 years | 26 Participants | 11 Participants | 22 Participants | 59 Participants |
| Age, Customized Mean Caregiver Age | 34.2 years STANDARD_DEVIATION 5.9 | 34.1 years STANDARD_DEVIATION 5.6 | 33.5 years STANDARD_DEVIATION 6.7 | 33.8 years STANDARD_DEVIATION 6.2 |
| Race/Ethnicity, Customized Child Race Black | 31 Participants | 17 Participants | 33 Participants | 81 Participants |
| Race/Ethnicity, Customized Child Race Non-Black | 7 Participants | 4 Participants | 7 Participants | 18 Participants |
| Region of Enrollment United States | 38 participants | 21 participants | 40 participants | 99 participants |
| Run-in Period ICS Adherence | 56 % of doses taken STANDARD_DEVIATION 26 | 50 % of doses taken STANDARD_DEVIATION 29 | 52 % of doses taken STANDARD_DEVIATION 30 | 53 % of doses taken STANDARD_DEVIATION 28 |
| Sex: Female, Male Child Sex Female | 18 Participants | 9 Participants | 16 Participants | 43 Participants |
| Sex: Female, Male Child Sex Male | 20 Participants | 12 Participants | 24 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 21 | 0 / 40 |
| other Total, other adverse events | 17 / 38 | 13 / 21 | 22 / 40 |
| serious Total, serious adverse events | 6 / 38 | 4 / 21 | 6 / 40 |
Outcome results
Primary
Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted)
Calculated as the mean daily proportion of prescribed doses taken by study month by study arm. Days that reflect \>1 were truncated to 1.
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Arm 1 | Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted) | Month 1 | 0.61 proportion of prescribed doses taken |
| Arm 1 | Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted) | Month 4 | 0.44 proportion of prescribed doses taken |
| Arm 1 | Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted) | Month 3 | 0.55 proportion of prescribed doses taken |
| Arm 1 | Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted) | Month 0 | 0.56 proportion of prescribed doses taken |
| Arm 1 | Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted) | Month 6 | 0.38 proportion of prescribed doses taken |
| Arm 1 | Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted) | Month 5 | 0.35 proportion of prescribed doses taken |
| Arm 1 | Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted) | Month 2 | 0.56 proportion of prescribed doses taken |
| Arm 2 | Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted) | Month 5 | 0.30 proportion of prescribed doses taken |
| Arm 2 | Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted) | Month 0 | 0.50 proportion of prescribed doses taken |
| Arm 2 | Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted) | Month 1 | 0.48 proportion of prescribed doses taken |
| Arm 2 | Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted) | Month 2 | 0.45 proportion of prescribed doses taken |
| Arm 2 | Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted) | Month 3 | 0.44 proportion of prescribed doses taken |
| Arm 2 | Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted) | Month 6 | 0.34 proportion of prescribed doses taken |
| Arm 2 | Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted) | Month 4 | 0.40 proportion of prescribed doses taken |
| Arm 3 | Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted) | Month 1 | 0.47 proportion of prescribed doses taken |
| Arm 3 | Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted) | Month 6 | 0.48 proportion of prescribed doses taken |
| Arm 3 | Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted) | Month 2 | 0.38 proportion of prescribed doses taken |
| Arm 3 | Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted) | Month 0 | 0.52 proportion of prescribed doses taken |
| Arm 3 | Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted) | Month 4 | 0.45 proportion of prescribed doses taken |
| Arm 3 | Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted) | Month 5 | 0.41 proportion of prescribed doses taken |
| Arm 3 | Mean Monthly Adherence to Inhaled Corticosteroid Regimen (Unadjusted) | Month 3 | 0.39 proportion of prescribed doses taken |
Comparison: Multivariate comparison of Experiment phase adherence (Months 1-3) comparing Arm 1 (Full Intervention arm) to Arm 3 (Active control). Arm 3 is used as the reference. This randomized controlled trial was powered for Arm 1 vs. Arm 3 comparisons, hence the Arm 1 vs. Arm 3 outcome data for adherence to the inhaled corticosteroid regime. The study did not have sufficient power for Arm 2 comparisons.95% CI: [2, 28]
Comparison: Multivariate comparison of Observation phase adherence (Months 4-6) comparing Arm 1 (Full Intervention arm) to Arm 3 (Active control). Arm 3 is used as the reference. This randomized controlled trial was powered for Arm 1 vs. Arm 3 comparisons, hence the Arm 1 vs. Arm 3 outcome data for adherence to the inhaled corticosteroid regime. The study did not have sufficient power for Arm 2 comparisons.95% CI: [-20, 7]
Secondary
Adherence Trajectory
Group-based trajectory modeling derived of adherence patterns - not reported by study arm. This secondary outcome was included in the event that there was no difference in adherence between study arms to help identify participant characteristics that were associated with different adherence patterns. The unit of measure is the percentage of participants that fall into each adherence category (low, medium, and high adherence) over a 6-month time period.
Time frame: 6 months
Population: The total cohort of 99 participants were analyzed to assign participants to one adherence group based on their adherence to the inhaled corticosteroid medication over the study interval. As pre-specified in the study protocol, this outcome measure represents group-based modeling of adherence patterns agnostic of study arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 | Adherence Trajectory | 20.2 percentage of study participants |
| Arm 2 | Adherence Trajectory | 41.5 percentage of study participants |
| Arm 3 | Adherence Trajectory | 38.2 percentage of study participants |
Secondary
Changes in Child Asthma Control Tool (cACT) Score
Assess the change in total cACT score or parental portion of the cACT from baseline to the second, third, fourth, and fifth study visits. The Child Asthma Control Tool (cACT) score ranges from 0 (poor control) to 27 (complete control) and was assessed at study visits 1 and 3 only. The parental portion of the cACT ranges from 0-15 and was assessed at all study visits. The greater the value, the better the control. The larger the difference (larger magnitude) of the value in the differences between the scores, the greater the improvement in controlling the child's asthma diagnosis.
Time frame: months 2, 4,7, 12
Population: The number analyzed in the study visits differ as some participants did not complete all study visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | Changes in Child Asthma Control Tool (cACT) Score | Study Visit 2* (only parental portion of ACT collected: Range 0-15) - Month 2 | 1.73 score on a scale | Standard Deviation 0.64 |
| Arm 1 | Changes in Child Asthma Control Tool (cACT) Score | Study Visit 3 - Month 4 | 2.19 score on a scale | Standard Deviation 0.96 |
| Arm 1 | Changes in Child Asthma Control Tool (cACT) Score | Study Visit 5* (only parental portion of ACT collected: Range 0-15) - Month 12 | 1.75 score on a scale | Standard Deviation 0.61 |
| Arm 1 | Changes in Child Asthma Control Tool (cACT) Score | Study Visit 4* (only parental portion of ACT collected: Range 0-15) - Month 7 | 2.29 score on a scale | Standard Deviation 0.62 |
| Arm 2 | Changes in Child Asthma Control Tool (cACT) Score | Study Visit 3 - Month 4 | 3.63 score on a scale | Standard Deviation 1.15 |
| Arm 2 | Changes in Child Asthma Control Tool (cACT) Score | Study Visit 2* (only parental portion of ACT collected: Range 0-15) - Month 2 | 2.86 score on a scale | Standard Deviation 0.73 |
| Arm 2 | Changes in Child Asthma Control Tool (cACT) Score | Study Visit 4* (only parental portion of ACT collected: Range 0-15) - Month 7 | 2.33 score on a scale | Standard Deviation 0.86 |
| Arm 2 | Changes in Child Asthma Control Tool (cACT) Score | Study Visit 5* (only parental portion of ACT collected: Range 0-15) - Month 12 | 2.41 score on a scale | Standard Deviation 0.71 |
| Arm 3 | Changes in Child Asthma Control Tool (cACT) Score | Study Visit 4* (only parental portion of ACT collected: Range 0-15) - Month 7 | 2.36 score on a scale | Standard Deviation 0.72 |
| Arm 3 | Changes in Child Asthma Control Tool (cACT) Score | Study Visit 3 - Month 4 | 1.85 score on a scale | Standard Deviation 1.36 |
| Arm 3 | Changes in Child Asthma Control Tool (cACT) Score | Study Visit 2* (only parental portion of ACT collected: Range 0-15) - Month 2 | 2.16 score on a scale | Standard Deviation 0.71 |
| Arm 3 | Changes in Child Asthma Control Tool (cACT) Score | Study Visit 5* (only parental portion of ACT collected: Range 0-15) - Month 12 | 1.74 score on a scale | Standard Deviation 0.79 |
Secondary
Healthcare Costs of Utilization
Calculate the costs associated with emergency room utilization, hospital utilization and oral steroid course prescriptions between study arms.
Time frame: 12 months
Population: This secondary outcome will not be analyzed because this data was not collected for reasons related to the onset of the COVID-19 pandemic.
Secondary
Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses
Calculate and compare the number of asthma-related emergency room visits, hospitalizations and oral steroid courses between study arms.
Time frame: 12 months
Population: The oral steroid course outcome was a secondary outcome added when we expanded inclusion criteria during the Coronavirus pandemic, so it is only reported for a proportion of participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm 1 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 1 hospitalization | 5 Participants |
| Arm 1 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 3 oral steroid courses | 2 Participants |
| Arm 1 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 3 hospitalizations | 0 Participants |
| Arm 1 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 0 hospitalizations | 32 Participants |
| Arm 1 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 4 oral steroid courses | 0 Participants |
| Arm 1 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 3 emergency department visits | 0 Participants |
| Arm 1 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 5 or more oral steroid courses | 0 Participants |
| Arm 1 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 2 emergency department visits | 3 Participants |
| Arm 1 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 2 hospitalizations | 1 Participants |
| Arm 1 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 1 emergency department visit | 4 Participants |
| Arm 1 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 1 oral steroid course | 6 Participants |
| Arm 1 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 0 emergency department visits | 31 Participants |
| Arm 1 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 2 oral steroid courses | 1 Participants |
| Arm 1 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 0 oral steroid courses | 21 Participants |
| Arm 2 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 3 hospitalizations | 0 Participants |
| Arm 2 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 2 hospitalizations | 1 Participants |
| Arm 2 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 2 emergency department visits | 0 Participants |
| Arm 2 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 1 oral steroid course | 4 Participants |
| Arm 2 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 2 oral steroid courses | 3 Participants |
| Arm 2 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 3 oral steroid courses | 1 Participants |
| Arm 2 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 4 oral steroid courses | 0 Participants |
| Arm 2 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 0 hospitalizations | 17 Participants |
| Arm 2 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 1 hospitalization | 3 Participants |
| Arm 2 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 0 emergency department visits | 14 Participants |
| Arm 2 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 1 emergency department visit | 6 Participants |
| Arm 2 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 3 emergency department visits | 1 Participants |
| Arm 2 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 0 oral steroid courses | 4 Participants |
| Arm 2 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 5 or more oral steroid courses | 1 Participants |
| Arm 3 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 1 oral steroid course | 8 Participants |
| Arm 3 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 5 or more oral steroid courses | 0 Participants |
| Arm 3 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 0 emergency department visits | 27 Participants |
| Arm 3 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 2 emergency department visits | 2 Participants |
| Arm 3 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 0 oral steroid courses | 13 Participants |
| Arm 3 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 1 emergency department visit | 8 Participants |
| Arm 3 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 1 hospitalization | 5 Participants |
| Arm 3 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 4 oral steroid courses | 1 Participants |
| Arm 3 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 3 oral steroid courses | 2 Participants |
| Arm 3 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 3 emergency department visits | 3 Participants |
| Arm 3 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 0 hospitalizations | 34 Participants |
| Arm 3 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 2 oral steroid courses | 1 Participants |
| Arm 3 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 2 hospitalizations | 0 Participants |
| Arm 3 | Number of Asthma-related Emergency Room Visits, Hospitalizations and Oral Steroid Courses | 3 hospitalizations | 1 Participants |