Asthma Link Effectiveness Trial
Recruiting · NCT06388460 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Massachusetts, Worcester
View the official record on ClinicalTrials.gov →Interventions studied
Asthma LinkEnhanced Usual Care
What this trial is about
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.
Who can take part
Age range
5 Years to 14 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Eligibility criteria (as published)
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 it is running
1 location listed across 1 US state.
- University of Massachusetts Chan Medical School - Worcester, Massachusetts, United States