School-based Asthma Therapy: Stage 2 Effectiveness Study - Full Text View

Sponsor:	University of Rochester
Collaborators:	National Heart, Lung, and Blood Institute (NHLBI) Halcyon Hill Foundation
Information provided by:	University of Rochester
ClinicalTrials.gov Identifier:	NCT01175369

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:

MedlinePlus related topics: Asthma Smoking and Youth

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:

Number of Symptom Free Days [ Time Frame: Average Symptom Free Days 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
Estimated Study Completion Date:	December 2011
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

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

National Heart, Lung, and Blood Institute (NHLBI)

Halcyon Hill Foundation

Investigators

Principal Investigator:

Jill S. Halterman, MD, MPH

University of Rochester

More Information

Publications:

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.

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.

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.

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.

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.

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. Epub 2009 Sep 30.

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. Epub 2009 Feb 23.

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. Epub 2008 May 12.

Responsible Party:	Jill Halterman, MD, MPH, University of Rochester
ClinicalTrials.gov Identifier:	NCT01175369 History of Changes
Other Study ID Numbers:	12308, 1R01HL079954-01A1
Study First Received:	June 23, 2010
Last Updated:	August 12, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Rochester:

Asthma

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases

Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012