School-based Asthma Therapy: Stage 2 Effectiveness Study

NCT ID: NCT01175369

Last Updated: 2014-08-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

530 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Usual Care

Usual asthma care

Group Type NO_INTERVENTION

No interventions assigned to this group

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).

Group Type EXPERIMENTAL

School-based Care

Intervention Type 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).

Interventions

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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 Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Halcyon Hill Foundation

OTHER

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Jill Halterman

Associate Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jill S. Halterman, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

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University of Rochester

Rochester, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 18446591 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19564303 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19329093 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19047246 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19796913 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19233588 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18922501 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21816697 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21911409 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22717938 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23400614 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24619226 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24528997 (View on PubMed)

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.

Reference Type RESULT
PMID: 21383275 (View on PubMed)

Other Identifiers

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1R01HL079954-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

12308

Identifier Type: -

Identifier Source: org_study_id

NCT00296998

Identifier Type: -

Identifier Source: nct_alias

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