Childhood AsthmaNCT06388460
Asthma Link Effectiveness Trial
A study testing Asthma Link in people with Childhood Asthma, run by University of Massachusetts, Worcester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Childhood Asthma
- What is being tested?
- Asthma Link
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2024to Apr 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 14 years
- All sexes
- No healthy volunteers
- Child
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655
Michelle Spano, 5088562990, michelle.spano@umassmed.edu
MIchelle Trivedi, MD MPH
About this study
Official title: Asthma Link: A Partnership Between Pediatric Practices, Schools, and Families to Improve Medication Adherence and Health Outcomes in Children With Poorly Controlled Asthma
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.
Read the detailed description
Asthma is an extremely common chronic disease in childhood with significant morbidity. The majority of asthma morbidity in children is due to medication non-adherence, and both morbidity and medication non-adherence disproportionately impact minoritized children. School-supervised asthma therapy ensures that children receive their preventive asthma medication daily at school and has shown efficacy in improving medication adherence and asthma health outcomes, particularly in low-income and racial/ethnic minority children. However, this strategy has not been widely adopted in practice to produce meaningful public health impact. To address this gap, the study team developed a new model, Asthma Link, which partners pediatric practices, schools, and families to deliver school-supervised asthma therapy. This intervention leverages established infrastructure and requires minimal resources to operate, enhancing sustainability in a real-world setting. The pilot trial of Asthma Link showed improved asthma symptoms when compared to an enhanced usual care condition, particularly among low-income, Black and Latino children, and demonstrated trial feasibility. Moreover, the research team has rigorously adapted this intervention for real-world use using input from diverse, multi-level community stakeholders.
This 14 site cluster randomized controlled trial will determine the effectiveness of Asthma Link versus an enhanced usual care condition in improving asthma health outcomes in school-aged children with poorly controlled asthma.
The investigators central hypothesis is that children in Asthma Link will have higher Asthma Control Test scores at 6 months compared with children in enhanced usual care; with maintained improvements at 12 months. The secondary hypothesis is that children in Asthma Link will have higher inhaled corticosteroid adherence and quality of life scores, and lower rates of asthma exacerbations, school absences and parental lost workdays compared with children in the enhanced usual care condition.
- Conditions
- Childhood Asthma
- Being tested
- Asthma Link, Enhanced Usual Care
- Keywords
- asthma, childhood asthma, medication adherence, school-supervised asthma therapy, real-world
- Medical subject headings
- Asthma, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Asthma LinkOther
Providers enroll patients to receive school-supervised asthma therapy and an asthma educational workbook
Enhanced Usual CareOther
Providers enroll patients to receive an asthma educational workbook
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 6 months, 12 months
Secondary outcomes (5)
Improving Medication Adherence
Survey to measure medication adherence
Measured: Baseline, 6 months, 12 months
Improving Healthcare Utilization
Survey questions to measure # of emergency room visits, # of hospital admissions, # of oral steroid courses due to asthma
Measured: Baseline, 6 months, 12 months
Reducing Parental Lost Workdays
Survey to measure the number of days a parent has missed work
Measured: Baseline, 6 months, 12 months
Reducing School Absences
Survey to measure the number of days a child has missed school
Measured: Baseline, 6 months, 12 months
Improving Quality of Life
Survey to measure the quality of life of the child and parent
Measured: Baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start4 Apr 2024
- Primary completionJan 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Michelle Trivedi, University of Massachusetts, Worcester
- Investigators
- Michelle Trivedi, MD, Principal investigator, UMass Chan Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388460
- Sponsor's protocol ID
- STUDY00001015
- Other IDs
- R01HL169229
- Status last verified
- Apr 2026
- First submitted
- 23 Apr 2024
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No