N/A
Completed N=66
Asthma Link: A Real World Application of School Supervised Asthma Therapy
Source: ClinicalTrials.gov NCT04942379 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcomePrimary: Recruitment Procedures Assessed by Number of Patients Screened — 143; 208 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recruitment Procedures Assessed by Number of Patients Screened |
143; 208 | — |
| PRIMARY Recruitment Procedures Assessed by Number of Eligible Participants |
66; 55 | — |
| PRIMARY Recruitment Procedures Assessed by Number of Patients Recruited Into the Study |
31; 35 | — |
| PRIMARY Recruitment Procedures Assessed by Number of Eligible Patients That Were Not Enrolled or Refused to Participate. |
35; 20 | — |
| PRIMARY Retention of Study Participants (Drop Out) |
0; 0 | — |
| PRIMARY Retention of Study Participants (Lost to Follow-up) |
4; 3 | — |
| PRIMARY Intervention Fidelity - Pediatric Practice |
31; 35 | — |
| PRIMARY Intervention Fidelity - Percentage of Enrolled Students Receiving Intervention |
31; 0 | — |
| PRIMARY Intervention Fidelity - School Nurse and Family Participation |
31; 0 | — |
| SECONDARY Acceptability - Participants |
— | — |
| SECONDARY Adoption of Asthma Link Intervention - Medical Provider |
— | — |
| SECONDARY Adoption of Asthma Link Intervention - Participant |
— | — |
| SECONDARY Adoption of Asthma Link Intervention - School Nurse |
— | — |
| SECONDARY Cost Effectiveness of Intervention |
— | — |
| SECONDARY Sustainability of Intervention |
— | — |
| SECONDARY Asthma Symptoms - Spirometry |
— | — |
| SECONDARY Asthma Symptoms - Asthma Control Test |
— | — |
| SECONDARY Asthma Symptoms - Maximum Symptoms Days |
— | — |
| SECONDARY Frequency of Healthcare Utilization Over Time |
— | — |
| SECONDARY Medication Adherence |
— | — |
| SECONDARY School Absences |
— | — |
Eligibility Criteria
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
- Diagnosis of a serious co-morbid illness during the past 5 years
- Developmental delay that would prevent study participation.
- Planning on moving from primary residence or moving outside of the school district in the next 1 year
- A sibling to a child participating in this study
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.
Parent Exclusion Criteria:
- Adults lacking capacity
- Prisoners
Medical Provider, School Nurse, Asthma Champion Inclusion Criteria:
- Able and willing to provide informed consent
Medical Provider, School Nurse, Asthma Champion Exclusion Criteria:
- Unable or unwilling to provide informed consent
Child eligibility for children enrolled in Asthma Link:
- children aged 6-17 years (enrolled in grade 1-12)
- prescribed daily inhaled corticosteroid (ICS) for asthma
- 1 or more courses of oral steroids in the past 2 years OR 1 or more hospitalizations or ED visits for asthma in the past 2 years OR 1 or more sick visits for asthma in the past year OR Asthma Control Test (ACT) score <19
- 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
Data sourced from ClinicalTrials.gov (NCT04942379). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.