Asthma
Conditions
Keywords
Pediatric, School Based Health Center
Brief summary
Project ASTHMA is a school-based health center intervention program that institutes guideline-based chronic asthma care and provides supervised administration with daily preventive asthma medications to improve asthma symptoms and lung function, reduce emergency visits, and decrease missed days of school among children from communities with health disparities.
Detailed description
Project ASTHMA in schools is a 7 month randomized control intervention pilot trial. Forty students, ages 4 to 14 years, with persistent asthma, or who utilize acute care facilities frequently for their asthma, will be recruited from 3 urban SBHCs in the fall of 2018. All students will receive NHLBI guideline-based asthma assessments to determine eligibility and proper dosing of preventive medication. The asthma assessment will include spirometry testing. All enrolled students and parents will receive asthma education at the time of enrollment. Eligible students will be randomized to an intervention or usual care group using permuted block randomization stratified by SBHCs. In collaboration with the student's PCP, the SBHCs' mid-level providers will prescribe the preventive medication to the students in the intervention group. These students will receive the morning dose of their preventive medication from the school nurse each school day for the remainder of the school year. Students and their parents will be responsible to administer the evening and non-school day doses. Students randomized to the usual care group will be referred back to their PCP for further asthma management. All participants will be re-evaluated at 1, 3 and 7 months after enrollment, and medication dose adjustments will be made in the intervention group as needed.
Interventions
OTHERAsthma Assessment & Management
Asthma Assessment \& Management based on NAEPP-EPR3 guidelines
OTHERAsthma Education
Asthma education on medications
OTHERController medication at school
Students will receive the morning dose of their daily preventive asthma medication at school on school days.
Sponsors
State University of New York at Buffalo
National Center for Advancing Translational Sciences (NCATS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Intervention group will receive the morning dose of their daily preventive asthma medication at school. The student & family will be responsible to administer the evening dose & both doses on non-school days.
Eligibility
Sex/Gender
ALL
Age
4 Years to 14 Years
Healthy volunteers
Yes
Inclusion criteria
* Active asthma * Diagnosed with asthma for at least 12 months * Enrolled in the school-based health center * Persistent asthma as defined by NAEPP-EPR3 guidelines OR at least 1 hospitalizations OR at least 2 ED/urgent care visits OR at least 2 courses of oral steroids for asthma in the previous 12 months for asthma
Exclusion criteria
* Underlying heart or lung disease other than asthma * Student has well controlled asthma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Number of Days Per Week, in the Previous 4 Weeks, of Daytime Asthma Symptoms From Baseline to 7-month Follow-up | Baseline, 1-month, 3-month, 5-month, 7-month | Total number of days per week, over the previous 4 weeks, of asthma symptoms Minimum: 0 Maximum: 7 Lower number indicates improvement The change in number of days per week of asthma symptoms from baseline to 7-month follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in ACT Score From Baseline to 7-month Follow-up | Baseline, 1-month, 3-month, 5-month, 7-month | Improvement in ACT (Asthma Control Test) score, a validated questionnaire for the assessment of asthma symptoms, which is included in the NAEPP-EPR3 guidelines for components of control. Minimum value is 0. Maximum value is 27. Higher scores mean a better outcome. Scores less than 19 suggest not well-controlled asthma. The change in ACT score from baseline to 7-month follow-up |
| Change in FEV1/FVC Ratio From Baseline to 7-month Follow-up | Baseline, 1-month, 3-month, 5-month, 7-month | Improvement FEV1/FVC ratio on spirometry. Higher number is a better outcome. FEV1/FVC ratio is a calculation used in pulmonary function testing to help diagnose lung conditions, particularly obstructive and restrictive lung diseases. It represents the proportion of air a person can exhale in the first second of a forced expiration (FEV1 - forced expiratory volume in 1 second) compared to the total amount of air they can exhale with maximal effort (FVC - forced vital capacity). The change in FEV1/FVC ratio from baseline to 7-month follow-up. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLucy C Holmes, MD, MPH
University at Buffalo
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 9.2 years |
| Asthma Control Test (ACT) | 14.8 units on a scale STANDARD_DEVIATION 4.27 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 16 |
| other Total, other adverse events | 0 / 13 | 0 / 16 |
| serious Total, serious adverse events | 0 / 13 | 0 / 16 |
Outcome results
None listed