search
Back to results

Aligning With Schools To Help Manage Asthma (Project ASTHMA)

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Asthma Assessment & Management
Asthma Education
Controller medication at school
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma focused on measuring Pediatric, School Based Health Center

Eligibility Criteria

4 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • John R. Oishei Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Usual Care

Arm Description

All participants will undergo an initial asthma assessment per the NAEPP-EPR3 (National Asthma Education and Prevention Program - Expert Panel Report 3) guidelines, as well as asthma education. Participants randomized to the intervention group will be prescribed the appropriate asthma therapy based on their assessment (i.e. providing 'asthma assessment & management'), and receive the morning dose of their daily asthma controller medication at school on school days.

All participants will undergo an initial asthma assessment per the NAEPP-EPR3 (National Asthma Education and Prevention Program - Expert Panel Report 3) guidelines, as well as asthma education. Participants randomized to the usual care group will be provided with the results of their asthma assessment and be instructed to follow up with their primary care provider. They will continue to receive all of their daily asthma controller medication at home.

Outcomes

Primary Outcome Measures

Change in Asthma Symptoms
decrease in asthma symptoms as defined by NAEPP-EPR3 guidelines, including ACT score

Secondary Outcome Measures

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.
Change in Lung function
improvement in spirometry
Change in ED/urgent care visits
Decrease in ED/urgent care visits
Change in Hospitalizations
Decrease in hospitalizations
Change in Oral/parenteral steroid use
Decrease in oral/parenteral steroid use
Change in Missed days of school
decrease in missed days of school

Full Information

First Posted
January 24, 2017
Last Updated
August 17, 2023
Sponsor
State University of New York at Buffalo
Collaborators
National Center for Advancing Translational Sciences (NCATS)
search

1. Study Identification

Unique Protocol Identification Number
NCT03032744
Brief Title
Aligning With Schools To Help Manage Asthma (Project ASTHMA)
Official Title
Aligning With Schools To Help Manage Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 17, 2017 (Actual)
Primary Completion Date
July 2019 (Actual)
Study Completion Date
June 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
Collaborators
National Center for Advancing Translational Sciences (NCATS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Pediatric, School Based Health Center

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
All participants will undergo an initial asthma assessment per the NAEPP-EPR3 (National Asthma Education and Prevention Program - Expert Panel Report 3) guidelines, as well as asthma education. Participants randomized to the intervention group will be prescribed the appropriate asthma therapy based on their assessment (i.e. providing 'asthma assessment & management'), and receive the morning dose of their daily asthma controller medication at school on school days.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
All participants will undergo an initial asthma assessment per the NAEPP-EPR3 (National Asthma Education and Prevention Program - Expert Panel Report 3) guidelines, as well as asthma education. Participants randomized to the usual care group will be provided with the results of their asthma assessment and be instructed to follow up with their primary care provider. They will continue to receive all of their daily asthma controller medication at home.
Intervention Type
Other
Intervention Name(s)
Asthma Assessment & Management
Intervention Description
Asthma Assessment & Management based on NAEPP-EPR3 guidelines
Intervention Type
Other
Intervention Name(s)
Asthma Education
Intervention Description
Asthma education on medications
Intervention Type
Other
Intervention Name(s)
Controller medication at school
Intervention Description
Students will receive the morning dose of their daily preventive asthma medication at school on school days.
Primary Outcome Measure Information:
Title
Change in Asthma Symptoms
Description
decrease in asthma symptoms as defined by NAEPP-EPR3 guidelines, including ACT score
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Change in ACT Score
Description
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.
Time Frame
7 months
Title
Change in Lung function
Description
improvement in spirometry
Time Frame
7 months
Title
Change in ED/urgent care visits
Description
Decrease in ED/urgent care visits
Time Frame
2 years
Title
Change in Hospitalizations
Description
Decrease in hospitalizations
Time Frame
2 years
Title
Change in Oral/parenteral steroid use
Description
Decrease in oral/parenteral steroid use
Time Frame
2 years
Title
Change in Missed days of school
Description
decrease in missed days of school
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucy C Holmes, MD, MPH
Organizational Affiliation
University at Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
John R. Oishei Children's Hospital
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33322963
Citation
Holmes LC, Orom H, Lehman HK, Lampkin S, Halterman JS, Akiki V, Supernault-Sarker AA, Butler SB, Piechowski D, Sorrentino PM, Chen Z, Wilding GE. A pilot school-based health center intervention to improve asthma chronic care in high-poverty schools. J Asthma. 2022 Mar;59(3):523-535. doi: 10.1080/02770903.2020.1864823. Epub 2021 Jan 6.
Results Reference
derived

Learn more about this trial

Aligning With Schools To Help Manage Asthma (Project ASTHMA)

We'll reach out to this number within 24 hrs