Asthma Link Effectiveness Trial: Cluster Randomized Controlled Trial

Childhood Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06388460
• Other study ID #: STUDY00001015
• Secondary ID: R01HL169229
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2024
• Est. completion date: April 2028

Study information

• Verified date: April 2024
• Source: University of Massachusetts, Worcester
• Contact: Michelle Trivedi, MD
• Phone: 7744418086
• Email: Michelle.Trivedi3[@]umassmed.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: April 2028
• Est. primary completion date: January 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Childhood Asthma

Intervention

Other:
• Asthma Link
Providers enroll patients to receive school-supervised asthma therapy and an asthma educational workbook
• Enhanced Usual Care
Providers enroll patients to receive an asthma educational workbook

Locations

Country	Name	City	State
United States	University of Massachusetts Chan Medical School	Worcester	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improving Asthma Symptoms	Asthma Control Test (ACT) to measure child's asthma control	Baseline, 6 months, 12 months
Secondary	Improving Medication Adherence	Survey to measure medication adherence	Baseline, 6 months, 12 months
Secondary	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
Secondary	Reducing Parental Lost Workdays	Survey to measure the number of days a parent has missed work	Baseline, 6 months, 12 months
Secondary	Reducing School Absences	Survey to measure the number of days a child has missed school	Baseline, 6 months, 12 months
Secondary	Improving Quality of Life	Survey to measure the quality of life of the child and parent	Baseline, 6 months, 12 months