Asthma Link Effectiveness Trial: Cluster Randomized Controlled Trial

Status Recruiting

Clinical Trial Summary

The goal of this cluster RCT 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.

Clinical Trial 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, our 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. Our 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, we have 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. Our 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. Our 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06388460
Study type	Interventional
Source	University of Massachusetts, Worcester
Contact	Michelle Trivedi, MD
Phone	7744418086
Email	Michelle.Trivedi3@umassmed.edu
Status	Recruiting
Phase	N/A
Start date	April 4, 2024
Completion date	April 2028

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.