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Completed

NCT Number: NCT01175369

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.

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Key information

Age range

3 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

School-based Care

Behavioral

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 outcomes

  1. Number of Symptom Free Days

    Time frame: Average Symptom Free Days, over 2 weeks, during peak asthma season (November-February)

    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 outcomes

  1. Cotinine Level

    Time frame: 2 month and approximately 9 month (end of school year) follow-up assessments

    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).

  2. Cost Effectiveness of the Intervention

    Time frame: approximately 9 months (length of school year)

    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.

  3. Additional Asthma Morbidity Outcomes

    Time frame: 1-9 months (Monthly Follow-up assessments)

    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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • Halcyon Hill Foundation
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: SBAT

Important dates

Study start
2006
Primary completion
2009
Study completion
2012
First posted
Aug 4, 2010
Registry last updated
Aug 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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