| NCT ID | NCT06388460 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Massachusetts, Worcester |
| Condition | Childhood Asthma |
| Study Type | INTERVENTIONAL |
| Enrollment | 350 participants |
| Start Date | 2024-04-04 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 350 participants in total. It began in 2024-04-04 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Michelle Trivedi, MD
PRINCIPAL INVESTIGATOR
UMass Chan Medical School
Frequently Asked Questions
Who can join the NCT06388460 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 14 Years, studying Childhood Asthma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06388460 currently recruiting?
Yes, NCT06388460 is actively recruiting participants. Contact the research team at Michelle.Trivedi3@umassmed.edu for enrollment information.
Where is the NCT06388460 trial being conducted?
This trial is being conducted at Worcester, United States.
Who is sponsoring the NCT06388460 clinical trial?
NCT06388460 is sponsored by University of Massachusetts, Worcester. The principal investigator is Michelle Trivedi, MD at UMass Chan Medical School. The trial plans to enroll 350 participants.
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