An interventional study of Asthma Link and Enhanced Usual Care in Childhood Asthma, sponsored by University of Massachusetts, Worcester. Recruiting at 1 site in United States. Open to participants aged 5 Years to 14 Years. Per ClinicalTrials.gov, last updated 2026-05-05.
Sponsored by University of Massachusetts, Worcester · Not applicable, Interventional, and Health services research
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.
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's planned enrollment of 350 is above the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →University of Massachusetts, Worcester is the lead sponsor of 288 studies on the registry; 54 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 18 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
STUDY INCLUSION/EXCLUSION CRITERIA:
Child Inclusion Criteria:
Child Exclusion Criteria:
Parent Inclusion Criteria:
Child eligibility for children enrolled in Asthma Link:
Practices in the Asthma Link condition will receive brief training on how to identify, refer and arrange for children with poorly controlled asthma to receive school-supervised therapy with the child's school health staff. Participants will receive an educational asthma workbook.
Other: Asthma Link
Practices in the Enhanced Usual Care condition will receive brief training on how to identify and refer the same group of children with poorly controlled asthma and these children will receive an educational asthma workbook.
Other: Enhanced Usual Care
Providers enroll patients to receive school-supervised asthma therapy and an asthma educational workbook
Providers enroll patients to receive an asthma educational workbook
Improving Asthma Symptoms
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.
Time frame: Baseline, 6 months, 12 months
Improving Medication Adherence
Survey to measure medication adherence
Time frame: Baseline, 6 months, 12 months
Improving Healthcare Utilization
Survey questions to measure # of emergency room visits, # of hospital admissions, # of oral steroid courses due to asthma
Time frame: Baseline, 6 months, 12 months
Reducing Parental Lost Workdays
Survey to measure the number of days a parent has missed work
Time frame: Baseline, 6 months, 12 months
Reducing School Absences
Survey to measure the number of days a child has missed school
Time frame: Baseline, 6 months, 12 months
Improving Quality of Life
Survey to measure the quality of life of the child and parent
Time frame: Baseline, 6 months, 12 months
Plan to share: No
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University of Massachusetts, Worcester