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Aligning With Schools To Help Manage Asthma (Project ASTHMA)

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ClinicalTrials.gov Identifier: NCT03032744
Recruitment Status : Recruiting
First Posted : January 26, 2017
Last Update Posted : January 9, 2019
Sponsor:
Information provided by (Responsible Party):
Lucy Holmes, MD, State University of New York at Buffalo

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.

Condition or disease Intervention/treatment Phase
Asthma Other: Asthma Assessment & Management Other: Asthma Education Other: Controller medication at school Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Aligning With Schools To Help Manage Asthma
Actual Study Start Date : January 17, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Intervention
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.
Other: Asthma Assessment & Management
Asthma Assessment & Management based on NAEPP-EPR3 guidelines

Other: Asthma Education
Asthma education on medications

Other: Controller medication at school
Students will receive the morning dose of their daily preventive asthma medication at school on school days.

Active Comparator: Usual Care
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.
Other: Asthma Assessment & Management
Asthma Assessment & Management based on NAEPP-EPR3 guidelines

Other: Asthma Education
Asthma education on medications




Primary Outcome Measures :
  1. Change in Asthma Symptoms [ Time Frame: 7 months ]
    decrease in asthma symptoms as defined by NAEPP-EPR3 guidelines, including ACT score


Secondary Outcome Measures :
  1. Change in ACT Score [ Time Frame: 7 months ]
    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.

  2. Change in Lung function [ Time Frame: 7 months ]
    improvement in spirometry

  3. Change in ED/urgent care visits [ Time Frame: 2 years ]
    Decrease in ED/urgent care visits

  4. Change in Hospitalizations [ Time Frame: 2 years ]
    Decrease in hospitalizations

  5. Change in Oral/parenteral steroid use [ Time Frame: 2 years ]
    Decrease in oral/parenteral steroid use

  6. Change in Missed days of school [ Time Frame: 2 years ]
    decrease in missed days of school



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032744


Contacts
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Contact: Lucy C Holmes, MD, MPH 716-323-0034 LHolmes@upa.chob.edu

Locations
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United States, New York
John R. Oishei Children's Hospital Recruiting
Buffalo, New York, United States, 14203
Contact: Lucy C Holmes, MD, MPH    716-323-0034    lholmes@upa.chob.edu   
Sponsors and Collaborators
State University of New York at Buffalo
Investigators
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Principal Investigator: Lucy C Holmes, MD, MPH University at Buffalo

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Responsible Party: Lucy Holmes, MD, Clinical Associate Professor of Pediatrics, State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT03032744     History of Changes
Other Study ID Numbers: IMPACT1
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lucy Holmes, MD, State University of New York at Buffalo:
Pediatric
School Based Health Center

Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases