School-supervised asthma therapy for children
Asthma Link: A Partnership Between Pediatric Practices, Schools, and Families to Improve Medication Adherence and Health Outcomes in Children With Poorly Controlled Asthma
This study tests if a school program that helps kids with asthma take their medicine can work better than just giving them an educational workbook, especially for children aged 5-14 who struggle with asthma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 5 Years to 14 Years |
| Sex | All |
| Sponsor | University of Massachusetts, Worcester Academic / other |
| Locations | 1 site (Worcester, Massachusetts) |
| Trial ID | NCT06388460 on ClinicalTrials.gov |
What this trial studies
This cluster randomized controlled trial aims to evaluate the effectiveness of the Asthma Link program, which provides school-supervised asthma therapy, compared to an educational workbook for children aged 5-14 with poorly controlled asthma. The intervention focuses on improving medication adherence and asthma symptoms, particularly among low-income and racial/ethnic minority children. By partnering pediatric practices, schools, and families, the program seeks to enhance asthma management in a real-world setting. The study builds on previous pilot findings that indicated improved asthma outcomes with this approach.
Who should consider this trial
Good fit: Ideal candidates are children aged 5-14 years with poorly controlled asthma who are prescribed daily inhaled corticosteroids.
Not a fit: Patients who are unable or unwilling to provide informed assent or have developmental delays that prevent participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve asthma management and health outcomes for children with poorly controlled asthma.
How similar studies have performed: Previous pilot trials have shown success with similar school-supervised asthma therapy approaches, particularly among low-income and minority populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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, 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
Where this trial is running
Worcester, Massachusetts
- University of Massachusetts Chan Medical School — Worcester, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Michelle Trivedi, MD — UMass Chan Medical School
- Study coordinator: Michelle Trivedi, MD
- Email: Michelle.Trivedi3@umassmed.edu
- Phone: 7744418086
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.