Aligning With Schools To Help Manage Asthma (Project ASTHMA)

Asthma Clinical Trial

Official title:

Aligning With Schools To Help Manage Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03032744
• Other study ID #: IMPACT1
• Secondary ID: UL1TR001412
• Status: Completed
• Phase: N/A
• Start date: January 17, 2017
• Est. completion date: June 2020

Study information

• Verified date: August 2023
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 2020
• Est. primary completion date: July 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• Asthma Assessment & Management
Asthma Assessment & Management based on NAEPP-EPR3 guidelines
• Asthma Education
Asthma education on medications
• Controller medication at school
Students will receive the morning dose of their daily preventive asthma medication at school on school days.

Locations

Country	Name	City	State
United States	John R. Oishei Children's Hospital	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York at Buffalo	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Asthma Symptoms	decrease in asthma symptoms as defined by NAEPP-EPR3 guidelines, including ACT score	7 months
Secondary	Change in ACT Score	Improvement in ACT score, a validated questionnaire for the assessment of asthma symptoms, which is included in the NAEPP-EPR3 guidelines for components of control.	7 months
Secondary	Change in Lung function	improvement in spirometry	7 months
Secondary	Change in ED/urgent care visits	Decrease in ED/urgent care visits	2 years
Secondary	Change in Hospitalizations	Decrease in hospitalizations	2 years
Secondary	Change in Oral/parenteral steroid use	Decrease in oral/parenteral steroid use	2 years
Secondary	Change in Missed days of school	decrease in missed days of school	2 years