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
  Purpose

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.


Condition Intervention
Asthma
Behavioral: School-based Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: School-Based Asthma Therapy: Stage 2 Effectiveness Study

Resource links provided by NLM:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Enrollment: 530
Study Start Date: August 2006
Study Completion Date: January 2012
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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).

  Eligibility

Ages Eligible for Study:   3 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01175369

Locations
United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Halcyon Hill Foundation
Investigators
Principal Investigator: Jill S. Halterman, MD, MPH University of Rochester
  More Information

Publications:

Responsible Party: Jill Halterman, Associate Professor of Pediatrics, University of Rochester
ClinicalTrials.gov Identifier: NCT01175369     History of Changes
Obsolete Identifiers: NCT00296998
Other Study ID Numbers: 12308, 1R01HL079954-01A1
Study First Received: June 23, 2010
Results First Received: January 14, 2013
Last Updated: July 25, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Asthma

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

ClinicalTrials.gov processed this record on October 23, 2014