Asthma in Children, Directly Observed Therapy
Conditions
Keywords
Asthma, Children, School-based health center, NIH Guideline-based care, Controller medication, Directly Observed Therapy
Brief summary
Children with asthma from communities that experience health inequities frequently do not receive guideline-based asthma care, and as a result, account for a disproportionate percentage of asthma exacerbations, emergency department visits, and hospitalizations. Project ASTHMA (Aligning with Schools To Help Manage Asthma) tests the effectiveness of school-based health centers as a delivery model to improve health outcomes by providing children with guideline-based asthma assessments and preventive medication management, directly observed therapy of their preventive medication to support adherence, and self-management support. If successful, this multicomponent intervention will represent a cost effective and sustainable model to reduce asthma morbidity in historically marginalized communities, and has the potential to impact communities throughout the United States where over 2,500 school-based health centers operate.
Interventions
OTHERAPP assessment and management of asthma
APPs will be trained to follow NIH guidelines for assessment and management of asthma, and to apply their knowledge to the care of the students. Students will also receive DOT of the morning dose of their controller medication.
Sponsors
State University of New York at Buffalo
National Institute on Minority Health and Health Disparities (NIMHD)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 13 Years
Healthy volunteers
No
Inclusion criteria
* uncontrolled asthma
Exclusion criteria
* other chronic lung disease such as cystic fibrosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asthma exacerbations | from 1 month after enrollment to the end of the school year for 1 school year; to be assessed after the end of the school year. | Number of asthma exacerbations requiring systemic steroids based on medical records |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daytime asthma symptoms | to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year | Frequency of daytime asthma symptoms based on questionnaire minimum value: 0 days maximum value: 28 days Higher scores mean a worse outcome. |
| Nighttime asthma symptoms | to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year | Frequency of nighttime asthma symptoms based on questionnaire minimum value: 0 nights maximum value: 28 nights Higher scores mean a worse outcome. |
| Spirometry - FEV1 | to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year | Forced Expiratory Volume in 1 second |
| Spirometry - FEV1/FVC ratio | to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year | FEV1/Forced Vital Capacity ratio |
| ED visits | from 1 month after enrollment to the end of the school year for 1 school year; to be assessed after the end of the school year. | Number of ED visits for asthma symptoms based on medical records |
| Urgent care visits | from 1 month after enrollment to the end of the school year for 1 school year; to be assessed after the end of the school year. | Number of urgent care visits for asthma symptoms based on medical records |
| Hospitalizations | from 1 month after enrollment to the end of the school year; to be assessed after the end of the school year. | Number of hospitalizations based on medical records |
| Quality of Life - caregiver | to be assessed at baseline and at 7-month follow-up for 1 school year | Children's Health Survey for Asthma, American Academy of Pediatrics Higher scores mean a better outcome. |
| Activity Limitation | to be assessed at baseline and 1-, 3-, 5- and 7-months after enrollment for 1 school year | Degree of activity limitation based on questionnaire Higher scores mean a worse outcome. |
| school absenteeism | from 1 month after enrollment to the end of the school year for 1 school year; to be assessed after the end of the school year. | Number of missed school days based on school records |
Countries
United States
Contacts
CONTACTLucy CY Holmes, MD, MPH
CONTACTDeanna Hamilton, MSEd
Outcome results
None listed