Asthma Link Effectiveness Trial
ConditionChildhood Asthma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-14
SponsorUniversity of Massachusetts, Worcester
About this trial
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
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Asthma Link
Other interventionProviders enroll patients to receive school-supervised asthma therapy and an asthma educational workbook
Enhanced Usual Care
Other interventionProviders enroll patients to receive an asthma educational workbook
Treatment groups
350 Participants
are divided into 2 treatment groupsGroup A: Asthma LinkExperimental treatment 1 intervention
Group B: Enhanced Usual CareActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline, 6 months, 12 monthsSecondary outcomes
1
Improving Medication Adherence
Survey to measure medication adherence
Time frame
Baseline, 6 months, 12 months2
Improving Healthcare Utilization
Survey questions to measure # of emergency room visits, # of hospital admissions, # of oral steroid courses due to asthma
Time frame
Baseline, 6 months, 12 months3
Reducing Parental Lost Workdays
Survey to measure the number of days a parent has missed work
Time frame
Baseline, 6 months, 12 months4
Reducing School Absences
Survey to measure the number of days a child has missed school
Time frame
Baseline, 6 months, 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Massachusetts, Worcester
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov