Asthma Link Effectiveness Trial: Cluster Randomized Controlled Trial

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

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.

Study Overview

• Status: Recruiting
• Conditions: Childhood Asthma
• Intervention / Treatment: Other: Asthma Link; Other: Enhanced Usual Care

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, 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 Type: Interventional
• Enrollment (Estimated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michelle Trivedi, MD; Phone Number: 7744418086; Email: Michelle.Trivedi3@umassmed.edu
• Study Contact Backup: Name: Michelle Spano, MA; Phone Number: 17746966875; Email: michelle.spano@umassmed.edu

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • Recruiting
      • University of Massachusetts Chan Medical School
      • Contact: Michelle Spano; Phone Number: 508-856-2990; Email: michelle.spano@umassmed.edu
      • Principal Investigator: MIchelle Trivedi, MD MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 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
• Asthma Control Test (ACT) score ≤19 OR 1 or more of ANY of following in the past 1 year: course of oral steroids, hospitalization, ED visit, sick visit for asthma
• parent/child report of poor ICS adherence on adherence checklist- i.e. child or parent says "Yes" when provider asks if they have difficulty remembering to take their medication or if they regularly take medication holidays or breaks
• able and willing to assent
• parental permission
• English or Spanish speaking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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; Providers enroll patients to receive school-supervised asthma therapy and an asthma educational workbook
Active Comparator: Enhanced Usual Care; 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 an asthma educational workbook

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improving Asthma Symptoms	Asthma Control Test (ACT) to measure child's asthma control	Baseline, 6 months, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improving Medication Adherence	Survey to measure medication adherence	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	Baseline, 6 months, 12 months
Reducing Parental Lost Workdays	Survey to measure the number of days a parent has missed work	Baseline, 6 months, 12 months
Reducing School Absences	Survey to measure the number of days a child has missed school	Baseline, 6 months, 12 months
Improving Quality of Life	Survey to measure the quality of life of the child and parent	Baseline, 6 months, 12 months

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Michelle Trivedi, MD, UMass Chan Medical School

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: April 23, 2024
• First Submitted That Met QC Criteria: April 23, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: asthma; medication adherence; childhood asthma; school-supervised asthma therapy; real-world
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: STUDY00001015; R01HL169229 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No