Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06388460
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-04-23
Brief Title:
Asthma Link Effectiveness Trial Cluster Randomized Controlled Trial
Sponsor:
University of Massachusetts Worcester
Organization:
University of Massachusetts Worcester
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this cluster RCT 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
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 racialethnic minority children However this strategy has not been widely adopted in practice to produce meaningful public health impact To address this gap our 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 Our 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 we have 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
Our 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 Our 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
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
Our 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 Our 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL169229 | NIH | None | httpsreporternihgovquickSearchR01HL169229 |