Recruiting

Observational Study

Sponsor:

University of Massachusetts, Worcester

Code:

NCT06388460

Conditions

Childhood Asthma

Eligibility Criteria

Sex: All

Age: 5 - 14

Healthy Volunteers: Not accepted

Interventions

Asthma Link

Enhanced Usual Care

Study Details

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.

Conditions

Childhood Asthma

Study ID

NCT06388460

Start date

Apr 4, 2024

Status verified date

Apr, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 14

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

350 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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

Primary outcome measure

  • Improving Asthma Symptoms [ Time Frame: Baseline, 6 months, 12 months ]

Central Contacts and Locations

Central contacts

Michelle Trivedi, MD

7744418086Michelle.Trivedi3@umassmed.edu

Michelle Spano, MA

17746966875michelle.spano@umassmed.edu

Locations

University of Massachusetts Chan Medical School

Recruiting

Worcester, Massachusetts, United States, 01655

Contacts

Michelle Spano

5088562990michelle.spano@umassmed.edu

Principal Investigator:

MIchelle Trivedi, MD MPH

More Information

Sponsor

University of Massachusetts, Worcester

Last update posted

May 5, 2026

Last verified

Apr, 2026

Keywords

  • asthma
  • childhood asthma
  • medication adherence
  • school-supervised asthma therapy
  • real-world

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Massachusetts, Worcester on 2026-05-05.