Asthma Link: A Partnership Between Pediatric Practices, Schools, and Families to Improve Medication Adherence and Health Outcomes in Children With Poorly Controlled Asthma

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 14
Healthy Volunteers: f
View:

• 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

• 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

Locations
United States
Massachusetts
University of Massachusetts Chan Medical School
RECRUITING
Worcester
Contact Information
Primary
Michelle Trivedi, MD
Michelle.Trivedi3@umassmed.edu
7744418086
Backup
Michelle Spano, MA
michelle.spano@umassmed.edu
17746966875
Time Frame
Start Date: 2024-04-04
Estimated Completion Date: 2028-04
Participants
Target number of participants: 350
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of Massachusetts, Worcester
Collaborators: National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov

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