School-based Asthma Therapy: Stage 2 Effectiveness Study (SBAT)
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
School-based Care
Sponsored by

About this trial
This is an interventional health services research trial for Asthma focused on measuring Asthma
Eligibility Criteria
Inclusion Criteria:
- Physician-diagnosed asthma
- Mild persistent to severe persistent asthma
- Ages 3-10 years
- Attending school in the Rochester City School District preschools or elementary schools
- Signed physician permission to enroll the child
- Parent or caregiver must consent to the intervention
Exclusion Criteria:
- Inability to speak and understand either English or Spanish
- No access to a working phone for follow-up surveys
- The family planning to leave the school district within fewer than 6 months
- The child having other significant medical conditions that could interfere with the assessment of asthma-related outcome measures
- children in foster care or other situations in which consent cannot be obtained from a guardian
- Current participation in other local asthma interventions
Sites / Locations
- University of Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Usual Care
School-based Care
Arm Description
Usual asthma care
The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).
Outcomes
Primary Outcome Measures
Number of Symptom Free Days
The primary outcome variable is the average number of symptom free days over 2 weeks assessed during peak asthma season (data collected during November, December, January and February during the school year).
Secondary Outcome Measures
Cotinine Level
To test the effectiveness of the environmental tobacco smoke (ETS) reduction portion of the study, we will compare baseline cotinine values to 2 month (for smoke exposed participants) and final follow-up assessments (for all participants).
Cost Effectiveness of the Intervention
Cost-effectiveness will examine the net program costs to the number of symptom-free days gained. Benefits will be described as the net difference in medical and productivity costs between children in the treatment and control groups.
Additional Asthma Morbidity Outcomes
We will look at additional asthma morbidity outcomes including symptom nights, days needing rescue medications, functional severity, days absent from school, and quality of life.
Full Information
NCT ID
NCT01175369
First Posted
June 23, 2010
Last Updated
July 25, 2014
Sponsor
University of Rochester
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Halcyon Hill Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01175369
Brief Title
School-based Asthma Therapy: Stage 2 Effectiveness Study
Acronym
SBAT
Official Title
School-Based Asthma Therapy: Stage 2 Effectiveness Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Halcyon Hill Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Asthma is the most common chronic illness of childhood, and hospitalization rates are increasing. In the US, impoverished children and children from minority ethnic and racial backgrounds suffer disproportionately from asthma. While National Heart, Lung, and Blood Institute (NHLBI) guidelines recommend daily preventive medications for all children with mild persistent to severe persistent asthma, studies indicate that many children in the US who should receive preventive medications are not receiving them. The overall goal of this project is to target an ethnically diverse population of inner-city schoolchildren with asthma and explore a school-based program to reduce asthma morbidity. We hypothesize that children receiving a comprehensive school-based intervention will experience less asthma-related morbidity compared to children receiving usual care. Our comprehensive school-based intervention consists of both administration of recommended preventive asthma medications in school (with dose adjustments according to NHLBI guidelines) and an environmental tobacco smoke (ETS) reduction program in the home for smoke-exposed children. Our secondary hypothesis is that, among the subgroup of smoke-exposed children, those who receive the school-based intervention with ETS reduction will experience less asthma morbidity than those who receive usual care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
530 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual asthma care
Arm Title
School-based Care
Arm Type
Experimental
Arm Description
The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).
Intervention Type
Behavioral
Intervention Name(s)
School-based Care
Intervention Description
The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).
Primary Outcome Measure Information:
Title
Number of Symptom Free Days
Description
The primary outcome variable is the average number of symptom free days over 2 weeks assessed during peak asthma season (data collected during November, December, January and February during the school year).
Time Frame
Average Symptom Free Days, over 2 weeks, during peak asthma season (November-February)
Secondary Outcome Measure Information:
Title
Cotinine Level
Description
To test the effectiveness of the environmental tobacco smoke (ETS) reduction portion of the study, we will compare baseline cotinine values to 2 month (for smoke exposed participants) and final follow-up assessments (for all participants).
Time Frame
2 month and approximately 9 month (end of school year) follow-up assessments
Title
Cost Effectiveness of the Intervention
Description
Cost-effectiveness will examine the net program costs to the number of symptom-free days gained. Benefits will be described as the net difference in medical and productivity costs between children in the treatment and control groups.
Time Frame
approximately 9 months (length of school year)
Title
Additional Asthma Morbidity Outcomes
Description
We will look at additional asthma morbidity outcomes including symptom nights, days needing rescue medications, functional severity, days absent from school, and quality of life.
Time Frame
1-9 months (Monthly Follow-up assessments)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Physician-diagnosed asthma
Mild persistent to severe persistent asthma
Ages 3-10 years
Attending school in the Rochester City School District preschools or elementary schools
Signed physician permission to enroll the child
Parent or caregiver must consent to the intervention
Exclusion Criteria:
Inability to speak and understand either English or Spanish
No access to a working phone for follow-up surveys
The family planning to leave the school district within fewer than 6 months
The child having other significant medical conditions that could interfere with the assessment of asthma-related outcome measures
children in foster care or other situations in which consent cannot be obtained from a guardian
Current participation in other local asthma interventions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jill S. Halterman, MD, MPH
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18446591
Citation
Halterman JS, Borrelli B, Fisher S, Szilagyi P, Yoos L. Improving care for urban children with asthma: design and methods of the School-Based Asthma Therapy (SBAT) trial. J Asthma. 2008 May;45(4):279-86. doi: 10.1080/02770900701854908.
Results Reference
background
PubMed Identifier
19564303
Citation
Fagnano M, van Wijngaarden E, Connolly HV, Carno MA, Forbes-Jones E, Halterman JS. Sleep-disordered breathing and behaviors of inner-city children with asthma. Pediatrics. 2009 Jul;124(1):218-25. doi: 10.1542/peds.2008-2525.
Results Reference
background
PubMed Identifier
19329093
Citation
Conn KM, Hernandez T, Puthoor P, Fagnano M, Halterman JS. Screen time use among urban children with asthma. Acad Pediatr. 2009 Jan-Feb;9(1):60-3. doi: 10.1016/j.acap.2008.10.001.
Results Reference
background
PubMed Identifier
19047246
Citation
Halterman JS, Borrelli B, Tremblay P, Conn KM, Fagnano M, Montes G, Hernandez T. Screening for environmental tobacco smoke exposure among inner-city children with asthma. Pediatrics. 2008 Dec;122(6):1277-83. doi: 10.1542/peds.2008-0104.
Results Reference
background
PubMed Identifier
19796913
Citation
Halterman JS, Borrelli B, Conn KM, Tremblay P, Blaakman S. Motivation to quit smoking among parents of urban children with asthma. Patient Educ Couns. 2010 May;79(2):152-5. doi: 10.1016/j.pec.2009.09.004. Epub 2009 Sep 30.
Results Reference
background
PubMed Identifier
19233588
Citation
Shone LP, Conn KM, Sanders L, Halterman JS. The role of parent health literacy among urban children with persistent asthma. Patient Educ Couns. 2009 Jun;75(3):368-75. doi: 10.1016/j.pec.2009.01.004. Epub 2009 Feb 23.
Results Reference
background
PubMed Identifier
18922501
Citation
Fagnano M, Conn KM, Halterman JS. Environmental tobacco smoke and behaviors of inner-city children with asthma. Ambul Pediatr. 2008 Sep-Oct;8(5):288-93. doi: 10.1016/j.ambp.2008.04.002. Epub 2008 May 12.
Results Reference
background
PubMed Identifier
21816697
Citation
Fagnano M, Bayer AL, Isensee CA, Hernandez T, Halterman JS. Nocturnal asthma symptoms and poor sleep quality among urban school children with asthma. Acad Pediatr. 2011 Nov-Dec;11(6):493-9. doi: 10.1016/j.acap.2011.05.006. Epub 2011 Aug 3.
Results Reference
background
PubMed Identifier
21911409
Citation
Fagnano M, Halterman JS, Conn KM, Shone LP. Health literacy and sources of health information for caregivers of urban children with asthma. Clin Pediatr (Phila). 2012 Mar;51(3):267-73. doi: 10.1177/0009922811421413. Epub 2011 Sep 12.
Results Reference
background
PubMed Identifier
22717938
Citation
Blaakman S, Tremblay PJ, Halterman JS, Fagnano M, Borrelli B. Implementation of a community-based secondhand smoke reduction intervention for caregivers of urban children with asthma: process evaluation, successes and challenges. Health Educ Res. 2013 Feb;28(1):141-52. doi: 10.1093/her/cys070. Epub 2012 Jun 20.
Results Reference
background
PubMed Identifier
23400614
Citation
Noyes K, Bajorska A, Fisher S, Sauer J, Fagnano M, Halterman JS. Cost-effectiveness of the School-Based Asthma Therapy (SBAT) program. Pediatrics. 2013 Mar;131(3):e709-17. doi: 10.1542/peds.2012-1883. Epub 2013 Feb 11.
Results Reference
background
PubMed Identifier
24619226
Citation
Koehler AD, Fagnano M, Montes G, Halterman JS. Elevated burden for caregivers of children with persistent asthma and a developmental disability. Matern Child Health J. 2014 Nov;18(9):2080-8. doi: 10.1007/s10995-014-1455-6.
Results Reference
background
PubMed Identifier
24528997
Citation
Evans KA, Halterman JS, Hopke PK, Fagnano M, Rich DQ. Increased ultrafine particles and carbon monoxide concentrations are associated with asthma exacerbation among urban children. Environ Res. 2014 Feb;129:11-9. doi: 10.1016/j.envres.2013.12.001. Epub 2014 Jan 11.
Results Reference
background
PubMed Identifier
21383275
Citation
Halterman JS, Szilagyi PG, Fisher SG, Fagnano M, Tremblay P, Conn KM, Wang H, Borrelli B. Randomized controlled trial to improve care for urban children with asthma: results of the School-Based Asthma Therapy trial. Arch Pediatr Adolesc Med. 2011 Mar;165(3):262-8. doi: 10.1001/archpediatrics.2011.1.
Results Reference
result
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School-based Asthma Therapy: Stage 2 Effectiveness Study
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