NCT01175369

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
530

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Aug 2006

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 4, 2010

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 15, 2013

Completed
Last Updated

August 1, 2014

Status Verified

August 1, 2013

Enrollment Period

2.8 years

First QC Date

June 23, 2010

Results QC Date

January 14, 2013

Last Update Submit

July 25, 2014

Conditions

Asthma

Keywords

Asthma

Outcome Measures

Primary Outcomes (1)

  • Number of Symptom Free Days

    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).

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

Secondary Outcomes (3)

  • Cotinine Level

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

  • Cost Effectiveness of the Intervention

    approximately 9 months (length of school year)

  • Additional Asthma Morbidity Outcomes

    1-9 months (Monthly Follow-up assessments)

Study Arms (2)

Usual Care

NO INTERVENTION

Usual asthma care

School-based Care

EXPERIMENTAL

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

Interventions

School-based CareBEHAVIORAL

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).

School-based Care

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (14)

  • 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.

    PMID: 18446591BACKGROUND

  • 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.

    PMID: 19564303BACKGROUND

  • 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.

    PMID: 19329093BACKGROUND

  • 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.

    PMID: 19047246BACKGROUND

  • 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.

    PMID: 19796913BACKGROUND

  • 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.

    PMID: 19233588BACKGROUND

  • 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.

    PMID: 18922501BACKGROUND

  • 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.

    PMID: 21816697BACKGROUND

  • 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.

    PMID: 21911409BACKGROUND

  • 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.

    PMID: 22717938BACKGROUND

  • 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.

    PMID: 23400614BACKGROUND

  • 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.

    PMID: 24619226BACKGROUND

  • 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.

    PMID: 24528997BACKGROUND

  • 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.

    PMID: 21383275RESULT

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title
Dr. Jill Halterman
Organization
University of Rochester
jill_halterman@urmc.rochester.edu
5852755798

Study Officials

  • Jill S. Halterman, MD, MPH

    University of Rochester

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

June 23, 2010

First Posted

August 4, 2010

Study Start

August 1, 2006

Primary Completion

June 1, 2009

Study Completion

January 1, 2012

Last Updated

August 1, 2014

Results First Posted

February 15, 2013

Record last verified: 2013-08

Locations

US(1)