Pediatric Asthma
Conditions
Brief summary
This project aims to improve guideline-based asthma care using enhanced communication and screening tools, telemedicine and directly observed therapy of preventive medications in city schools. Web-based screening will be used to identify children with persistent or poorly controlled asthma and to send reports to the child's primary care doctor. Children in the SB-TEAM group will receive a telemedicine asthma assessment in school and be prescribed a daily preventive asthma medication to be taken through school-based directly observed therapy. The overall aim of this study is to evaluate the use of the SB-TEAM intervention for improving guideline based care, enhancing adherence to effective preventive medications and at reducing morbidity among young urban children with asthma.
Interventions
OTHEREnhanced Usual Care
OTHERSchool-Based Telemedicine Enhanced Asthma Management
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
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
1. Physician-diagnosed asthma (based on parent report) 2. Persistent asthma or poor asthma control (based on NHLBI guidelines). Any 1 of the following: * In past month, \>2 days per week with asthma symptoms * \>2 days per week with rescue medication use * \>2 days per month with nighttime symptoms * \>=2 asthma episodes during the past year that required systemic corticosteroids. 3. Age \>=3 and =\<10 years 4. Attending school in Rochester City School District preschools or elementary schools
Exclusion criteria
1. Inability to speak and understand English or Spanish 2. No access to a phone for follow-up surveys 3. Family planning to leave the district within fewer than 6 months. 4. The child having other significant medical conditions, including congenital heart disease, cystic fibrosis, or other chronic lung disease, that could interfere with the assessment of asthma-related measures. 5. Children in foster care or other situations in which consent cannot be obtained from a guardian.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Number of Days Without Asthma Symptoms (Symptom Free Days) | Average number of days, over 2 weeks, during peak winter season (November-March), assessed over 4 years. | The primary outcome measure is asthma morbidity between groups. We will measure asthma morbidity by looking at the average number of days without asthma symptoms (symptom free days) over 2 weeks, during each follow-up assessment during the peak winter season (November-March). Symptom free days are defined as 24 hour periods of no asthma symptoms including, coughing, wheezing, tightness in the chest or shortness of breath. The number of symptom free days will be reported by the child's caregiver. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| School-based Telemedicine Enhanced Asthma Mangement Group We will use a web-based system to assess asthma severity or control and will send a symptom report to the child's primary care physician (PCP). Children randomized to the SB-TEAM group, will receive a telemedicine visit in the school health office at the start of the school year to provide an initial asthma assessment. The telemedicine provider will deliver brief asthma education and referrals to community resources, and will send a guideline-based preventive medication prescription electronically to a local pharmacy. The pharmacy will deliver the medications to home and school, and the school nurse will administer the medication as directly observed therapy throughout the school year. Follow-up telemedicine assessments will occur twice during the study period. These follow-up visits will focus on assessment of control, assessment of ongoing triggers or co-morbid conditions, and brief asthma education.
School-Based Telemedicine Enhanced Asthma Management | 200 |
| Enhanced Usual Care Group Children randomized to the enhanced usual care group will receive a symptom assessment using national care guidelines, a recommendation for appropriate preventive medications, and asthma education materials. We will use the web-based system to send a symptom report to the child's PCP with guideline-based recommendations for preventive care. We will provide systematic feedback to the family and providers at the same intervals as in the SB-TEAM group's telemedicine visits, by prompting providers to use care guidelines, and caregivers to schedule recommended follow-up visits with the PCP.
Enhanced Usual Care | 200 |
| Total | 400 |
Baseline characteristics
| Characteristic | Enhanced Usual Care Group | Total | School-based Telemedicine Enhanced Asthma Mangement Group |
|---|---|---|---|
| Age, Continuous | 7.9 years STANDARD_DEVIATION 1.7 | 7.8 years STANDARD_DEVIATION 1.7 | 7.7 years STANDARD_DEVIATION 1.7 |
| Race/Ethnicity, Customized African American | 118 Participants | 230 Participants | 112 Participants |
| Race/Ethnicity, Customized Hispanic | 60 Participants | 127 Participants | 67 Participants |
| Race/Ethnicity, Customized Other | 22 Participants | 43 Participants | 21 Participants |
| Region of Enrollment United States | 200 participants | 400 participants | 200 participants |
| Sex: Female, Male Female | 76 Participants | 153 Participants | 77 Participants |
| Sex: Female, Male Male | 124 Participants | 247 Participants | 123 Participants |
| Symptom-Free Days over two weeks | 7.4 Days STANDARD_DEVIATION 5.1 | 7.2 Days STANDARD_DEVIATION 5.1 | 7.0 Days STANDARD_DEVIATION 5.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 200 | 0 / 200 |
| other Total, other adverse events | 0 / 200 | 0 / 200 |
| serious Total, serious adverse events | 0 / 200 | 0 / 200 |
Outcome results
Primary
Average Number of Days Without Asthma Symptoms (Symptom Free Days)
The primary outcome measure is asthma morbidity between groups. We will measure asthma morbidity by looking at the average number of days without asthma symptoms (symptom free days) over 2 weeks, during each follow-up assessment during the peak winter season (November-March). Symptom free days are defined as 24 hour periods of no asthma symptoms including, coughing, wheezing, tightness in the chest or shortness of breath. The number of symptom free days will be reported by the child's caregiver.
Time frame: Average number of days, over 2 weeks, during peak winter season (November-March), assessed over 4 years.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| School-based Telemedicine Enhanced Asthma Mangement Group | Average Number of Days Without Asthma Symptoms (Symptom Free Days) | 11.6 Days | Standard Deviation 2.7 |
| Enhanced Usual Care Group | Average Number of Days Without Asthma Symptoms (Symptom Free Days) | 10.97 Days | Standard Deviation 3.2 |
p-value: <0.05Regression, Linear