Trials / Completed
CompletedNCT04942379
Asthma Link: A Real World Application of School Supervised Asthma Therapy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 66 (actual)
- Sponsor
- University of Massachusetts, Worcester · Academic / Other
- Sex
- All
- Age
- 6 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this study is to assess the feasibility of a clinical trial to evaluate the impact and process of deploying school-supervised asthma therapy in a real-world setting for children with poorly controlled asthma (aged 6-17 years).
Detailed description
The proposed 4-site pilot cluster randomized controlled trial will assess the feasibility of conducting a clinical trial of Asthma Link, a real-world school-supervised asthma therapy program. We will compare the impact of Asthma Link deployed in 2 pediatric practice sites versus Enhanced usual care deployed in 2 comparator sites, with 18 parent-child dyads enrolled per site (N=72 dyads). Primary trial outcomes will be participant recruitment, retention, and intervention fidelity. Secondary trial outcomes will be differences in the frequency of asthma symptoms, emergency department visits, hospital admissions, courses of oral corticosteroids, spirometry values, medication adherence and school absences between intervention and enhanced usual care sites at 3, 6 and 12 month follow up. Additionally we will assess process outcomes (acceptability, adoption, costs, sustainability).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Asthma Link | Providers enroll patients in school nurse supervised daily controller asthma medication delivery |
| OTHER | Enhanced Usual Care | Providers counsel patients on behavioral strategies to improve medication adherence. Patients also receive an asthma workbook outlining behavioral strategies for asthma medication adherence. |
Timeline
- Start date
- 2021-08-10
- Primary completion
- 2023-03-27
- Completion
- 2023-08-22
- First posted
- 2021-06-28
- Last updated
- 2024-07-19
- Results posted
- 2024-06-06
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04942379. Inclusion in this directory is not an endorsement.