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Clinical Trials/NCT06388460
NCT06388460
Recruiting
Not Applicable

Asthma Link: A Partnership Between Pediatric Practices, Schools, and Families to Improve Medication Adherence and Health Outcomes in Children With Poorly Controlled Asthma

University of Massachusetts, Worcester1 site in 1 country350 target enrollmentApril 4, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Childhood Asthma
Sponsor
University of Massachusetts, Worcester
Enrollment
350
Locations
1
Primary Endpoint
Improving Asthma Symptoms
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 4, 2024
End Date
April 2028
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Massachusetts, Worcester
Responsible Party
Principal Investigator
Principal Investigator

Michelle Trivedi

Associate Professor

University of Massachusetts, Worcester

Eligibility Criteria

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

Exclusion Criteria

  • Unable or unwilling to provide informed assent
  • Developmental delay that would prevent study participation.
  • Parent Inclusion Criteria:
  • Parent/guardian to patient
  • 18 years or older
  • Able to understand and communicate in English or Spanish
  • Able and willing to provide informed consent.
  • Child eligibility for children enrolled in Asthma Link:
  • children aged 5-14 years (enrolled in grade K-8)
  • prescribed daily inhaled corticosteroid (ICS) for asthma

Outcomes

Primary Outcomes

Improving Asthma Symptoms

Time Frame: 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 Outcomes

  • Improving Medication Adherence(Baseline, 6 months, 12 months)
  • Improving Quality of Life(Baseline, 6 months, 12 months)
  • Improving Healthcare Utilization(Baseline, 6 months, 12 months)
  • Reducing Parental Lost Workdays(Baseline, 6 months, 12 months)
  • Reducing School Absences(Baseline, 6 months, 12 months)

Study Sites (1)

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