Asthma Link Effectiveness Trial

NCT06388460 | Recruiting DMC

• 2 other identifiers: STUDY00001015R01HL169229
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Improving Asthma Symptoms

  Asthma Control Test to measure child's asthma control on a scale of 0-25. A score of 19 or less is considered poorly controlled asthma.

  Baseline, 6 months, 12 months

Secondary Outcomes (5)

• Improving Medication Adherence

  Baseline, 6 months, 12 months

• Improving Healthcare Utilization

  Baseline, 6 months, 12 months

• Reducing Parental Lost Workdays

  Baseline, 6 months, 12 months

• Reducing School Absences

  Baseline, 6 months, 12 months

• Improving Quality of Life

  Baseline, 6 months, 12 months

Study Arms (2)

Asthma Link

EXPERIMENTAL

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.

Other: Asthma Link

Enhanced Usual Care

ACTIVE COMPARATOR

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.

Other: Enhanced Usual Care

Interventions

Asthma Link OTHER

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

Asthma Link

Enhanced Usual Care OTHER

Providers enroll patients to receive an asthma educational workbook

Enhanced Usual Care

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of Massachusetts, Worcester: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01655, United States

RECRUITING

MeSH Terms

Conditions

Asthma; Medication Adherence

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Michelle Trivedi, MD

  UMass Chan Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Trivedi, MD

CONTACT

7744418086; Michelle.Trivedi3@umassmed.edu

Michelle Spano, MA

CONTACT

17746966875; michelle.spano@umassmed.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 29, 2024
• Study Start: April 4, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)