Childhood Asthma
Conditions
Keywords
asthma, childhood asthma, medication adherence, school-supervised asthma therapy, real-world
Brief summary
The goal of this cluster Randomized Control Trial is to determine the effectiveness of Asthma Link, a school supervised asthma therapy program, compared with an educational asthma workbook, in improving asthma symptoms for children with poorly controlled asthma aged 5-14.
Detailed description
Asthma is an extremely common chronic disease in childhood with significant morbidity. The majority of asthma morbidity in children is due to medication non-adherence, and both morbidity and medication non-adherence disproportionately impact minoritized children. School-supervised asthma therapy ensures that children receive their preventive asthma medication daily at school and has shown efficacy in improving medication adherence and asthma health outcomes, particularly in low-income and racial/ethnic minority children. However, this strategy has not been widely adopted in practice to produce meaningful public health impact. To address this gap, the study team developed a new model, Asthma Link, which partners pediatric practices, schools, and families to deliver school-supervised asthma therapy. This intervention leverages established infrastructure and requires minimal resources to operate, enhancing sustainability in a real-world setting. The pilot trial of Asthma Link showed improved asthma symptoms when compared to an enhanced usual care condition, particularly among low-income, Black and Latino children, and demonstrated trial feasibility. Moreover, the research team has rigorously adapted this intervention for real-world use using input from diverse, multi-level community stakeholders. This 14 site cluster randomized controlled trial will determine the effectiveness of Asthma Link versus an enhanced usual care condition in improving asthma health outcomes in school-aged children with poorly controlled asthma. The investigators central hypothesis is that children in Asthma Link will have higher Asthma Control Test scores at 6 months compared with children in enhanced usual care; with maintained improvements at 12 months. The secondary hypothesis is that children in Asthma Link will have higher inhaled corticosteroid adherence and quality of life scores, and lower rates of asthma exacerbations, school absences and parental lost workdays compared with children in the enhanced usual care condition.
Interventions
OTHERAsthma Link
Providers enroll patients to receive school-supervised asthma therapy and an asthma educational workbook
OTHEREnhanced Usual Care
Providers enroll patients to receive an asthma educational workbook
Sponsors
University of Massachusetts, Worcester
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
STUDY INCLUSION/
Exclusion criteria
Child Inclusion Criteria: * Meet the eligibility criteria for Asthma Link (as described below) * Enrolled in Asthma Link (if randomized to the Asthma Link Condition) * Able and willing to provide informed assent Child
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improving Asthma Symptoms | Baseline, 6 months, 12 months | Asthma Control Test to measure child's asthma control on a scale of 0-25. A score of 19 or less is considered poorly controlled asthma. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improving Medication Adherence | Baseline, 6 months, 12 months | Survey to measure medication adherence |
| Improving Healthcare Utilization | Baseline, 6 months, 12 months | Survey questions to measure # of emergency room visits, # of hospital admissions, # of oral steroid courses due to asthma |
| Reducing Parental Lost Workdays | Baseline, 6 months, 12 months | Survey to measure the number of days a parent has missed work |
| Reducing School Absences | Baseline, 6 months, 12 months | Survey to measure the number of days a child has missed school |
| Improving Quality of Life | Baseline, 6 months, 12 months | Survey to measure the quality of life of the child and parent |
Countries
United States
Contacts
CONTACTMichelle Trivedi, MD
CONTACTMichelle Spano, MA
PRINCIPAL_INVESTIGATORMichelle Trivedi, MD
UMass Chan Medical School
Outcome results
None listed