Asthma Link Effectiveness Trial

NCT ID: NCT06388460

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-04
• Study Completion Date: 2028-04-30

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.

Conditions

Childhood Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Asthma Link

Intervention Type: OTHER

Providers enroll patients to receive school-supervised asthma therapy and an asthma educational workbook

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.

Group Type: ACTIVE_COMPARATOR

Enhanced Usual Care

Intervention Type: OTHER

Providers enroll patients to receive an asthma educational workbook

Interventions

Asthma Link

Providers enroll patients to receive school-supervised asthma therapy and an asthma educational workbook

Intervention Type: OTHER

Enhanced Usual Care

Providers enroll patients to receive an asthma educational workbook

Intervention Type: OTHER

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

• 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, Emergency Department 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

Exclusion Criteria

• Unable or unwilling to provide informed assent
• Developmental delay that would prevent study participation.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Michelle Trivedi

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michelle Trivedi, MD

Role: PRINCIPAL_INVESTIGATOR

UMass Chan Medical School

Locations

University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michelle Trivedi, MD

Role: CONTACT

Michelle.Trivedi3@umassmed.edu

7744418086

Michelle Spano, MA

Role: CONTACT

michelle.spano@umassmed.edu

17746966875

Facility Contacts

Michelle Spano

Role: primary

michelle.spano@umassmed.edu

5088562990

Other Identifiers

R01HL169229

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00001015

Identifier Type: -

Identifier Source: org_study_id