School-based Asthma Therapy: Stage 2 Effectiveness Study (SBAT)

This study has been completed.
Sponsor:
Collaborators:
Halcyon Hill Foundation
Information provided by (Responsible Party):
Jill Halterman, University of Rochester
ClinicalTrials.gov Identifier:
NCT01175369
First received: June 23, 2010
Last updated: July 25, 2014
Last verified: August 2013

June 23, 2010
July 25, 2014
August 2006
June 2009   (final data collection date for primary outcome measure)
Number of Symptom Free Days [ Time Frame: Average Symptom Free Days, over 2 weeks, during peak asthma season (November-February) ] [ Designated as safety issue: No ]
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).
Number of Symptom Free Days [ Time Frame: November-February (Peak Asthma Season) ] [ Designated as safety issue: No ]
The primary outcome variable is number of symptom free days over 2 weeks assessed during peak asthma season.
Complete list of historical versions of study NCT01175369 on ClinicalTrials.gov Archive Site
  • Cotinine Level [ Time Frame: 2 month and approximately 9 month (end of school year) follow-up assessments ] [ Designated as safety issue: No ]
    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 [ Time Frame: approximately 9 months (length of school year) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1-9 months (Monthly Follow-up assessments) ] [ Designated as safety issue: No ]
    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.
  • Cotinine level [ Time Frame: 2 month and approximately 9 month (end of school year) follow-up assessments ] [ Designated as safety issue: No ]
    To test the effectiveness of the 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 [ Time Frame: approximately 9 months (length of school year) ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1-9 months (Monthly Follow-up assessments) ] [ Designated as safety issue: No ]
    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.
Not Provided
Not Provided
 
School-based Asthma Therapy: Stage 2 Effectiveness Study
School-Based Asthma Therapy: Stage 2 Effectiveness Study

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Asthma
Behavioral: School-based 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).
  • No Intervention: Usual Care
    Usual asthma care
  • Experimental: School-based 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).
    Intervention: Behavioral: School-based Care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
530
January 2012
June 2009   (final data collection date for primary outcome measure)

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
Both
3 Years to 10 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01175369
12308, 1R01HL079954-01A1
No
Jill Halterman, University of Rochester
University of Rochester
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Halcyon Hill Foundation
Principal Investigator: Jill S. Halterman, MD, MPH University of Rochester
University of Rochester
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP