Actively Recruiting

Phase Not Applicable
Age: 5Years - 14Years
All Genders
ID06388460

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

Led by University of Massachusetts, Worcester · Updated on 2026-05-05

350

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

Sponsors

U

University of Massachusetts, Worcester

Lead Sponsor

N

National Institutes of Health (NIH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims 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 aged 5 to 14 with poorly controlled asthma. Asthma is a common chronic condition in childhood, with medication non-adherence being a major cause of complications, especially among low-income and racial/ethnic minority children. The study involves 14 sites and focuses on improving asthma control, medication adherence, quality of life, and reducing asthma-related complications and school absences. The trial compares two groups: one receiving Asthma Link, which includes daily school-supervised asthma therapy alongside an educational asthma workbook, and another receiving enhanced usual care consisting of an educational asthma workbook alone. Pediatric practices involved receive training to identify and refer children with poorly controlled asthma to participate in the respective programs. The intervention leverages partnerships between pediatric practices, schools, and families to support medication adherence in a sustainable, real-world setting. Participants are monitored over 12 months, with assessments at baseline, 6 months, and 12 months to evaluate asthma symptom control using the Asthma Control Test and other measures. Researchers will also track medication adherence, healthcare use, school absences, parental workdays lost, and quality of life. Children and their parents provide assent and consent, and the study includes questionnaires and checklists to monitor progress and adherence. The total participation duration spans one year, with ongoing evaluations to assess the impact of the interventions.

CONDITIONS

Brief Title

Asthma Link Effectiveness Trial

Who Can Participate

Age: 5Years - 14Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 5 to 14 years (enrolled in grade K-8)
  • Prescribed daily inhaled corticosteroid (ICS) for asthma
  • Asthma Control Test (ACT) score of 19 or less OR one or more asthma-related events in the past year (oral steroids, hospitalization, emergency visit, or sick visit)
  • Parent or child reports difficulty adhering to ICS medication
  • Able and willing to provide informed assent (children) or consent (parents/guardians)
  • Parent/guardian aged 18 or older
  • Able to understand and communicate in English or Spanish
Not Eligible

You will not qualify if you...

  • Unable or unwilling to provide informed assent
  • Developmental delay preventing study participation

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 months

Participants receive either school-supervised asthma therapy with an educational workbook or an educational asthma workbook alone, based on their assigned group.

Assessment visits at baseline, 6 months, and 12 months

Trial Site Locations

Total: 1 location

1

University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States, 01655

Actively Recruiting

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Research Team

M

Michelle Trivedi, MD

M

Michelle Spano, MA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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