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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06320210
Other study ID # IRB19-1308
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 31, 2023
Est. completion date December 30, 2025

Study information

Verified date May 2024
Source University of Chicago
Contact Anna Volerman, MD
Phone 773-702-5905
Email avbeaser@bsd.uchicago.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Research has shown that adherence to evidence-based asthma guidelines leads to improved outcomes, yet critical gaps remain in the implementation of these guidelines, particularly among minority and low-income youth. Schools represent a crucial point of intervention, as demonstrated by school-based asthma programs that have addressed individual components of the guidelines with promising results. This project aims to develop, implement, and evaluate a pragmatic, multi-component asthma program that builds upon existing targeted interventions to fully implement the asthma guidelines and integrate them in school practices to foster sustainability. The investigator seeks to understand whether this type of program will improve asthma outcomes at the child and school level.


Description:

Significant health disparities persist in childhood asthma prevalence and morbidity despite existing evidence-based asthma guidelines that have been shown to improve outcomes. Schools are an integral partner in asthma management. Prior literature has outlined various targeted school-based interventions with some positive outcomes; however, these programs focus on individual components of the guidelines and take place transiently without integration into school processes for sustainability. To more comprehensively impact asthma care, schools have enacted policies to support guideline-based practices; however, implementation falls short and thus these policies have not led to effective, systemic practices. Therefore, this project aims to bridge the gap in the implementation of asthma guidelines and policies by developing and evaluating a pragmatic, multicomponent school-directed, child-centered asthma program that builds upon existing targeted interventions and is integrated in the school to foster sustainability. This innovative project contributes beyond existing school-based programs by simultaneously and pragmatically implementing multiple components of the asthma guidelines through school-wide systems and streamlined processes led by lay health workers. A multi-level program will be put in place for all students and families within the school. Intervention components will include: in-depth training for current school staff who are critical in asthma care, restructured processes to identify students with asthma, technological adaptations to create integrated tracking systems for asthma care and absenteeism, strategies to enhance communication about asthma within school and between school and home, protocols for routine care (e.g., participation in gym/recess) and emergencies, and education for all students about asthma.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date December 30, 2025
Est. primary completion date August 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years and older
Eligibility Participants will be included in the study if: 1. The participant either works at, attends, or is the legal guardian of a child who attends one of the two elementary schools included in the study from the University of Chicago Charter Schools - North Kenwood Oakland and Donoghue. 2. The child participant has a diagnosis of asthma OR the parent participant is legal guardian of a child with asthma. 3. The adult stakeholder is 18 years or older. Participants will be excluded from the study if: 1. The participant declines or is unable to provide consent/assent 2. The participant does not speak or read English 3. The participant has already enrolled in the study

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Multicomponent program
The intervention is a multi-component program that includes in-depth training for current school teachers/staff who are critical in asthma care, restructured processes to identify students with asthma, technological adaptations to support integrated systems for asthma care and absenteeism, strategies to enhance communication about asthma within school and between school and home, protocols for routine care (e.g., participation in gym/recess) and emergencies, and education for all students about asthma.

Locations

Country Name City State
United States University of Chicago Charter Schools Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

References & Publications (37)

Akinbami LJ, Moorman JE, Garbe PL, Sondik EJ. Status of childhood asthma in the United States, 1980-2007. Pediatrics. 2009 Mar;123 Suppl 3:S131-45. doi: 10.1542/peds.2008-2233C. — View Citation

Akinbami LJ, Simon AE, Rossen LM. Changing Trends in Asthma Prevalence Among Children. Pediatrics. 2016 Jan;137(1):1-7. doi: 10.1542/peds.2015-2354. Epub 2015 Dec 28. — View Citation

Anderson ME, Freas MR, Wallace AS, Kempe A, Gelfand EW, Liu AH. Successful school-based intervention for inner-city children with persistent asthma. J Asthma. 2004 Jun;41(4):445-53. doi: 10.1081/jas-120033987. — View Citation

Asthma Management Policy. Chicago Public Schools Policy Manual; 2012.

Bloom B, Jones LI, Freeman G. Summary health statistics for U.S. children: National Health Interview Survey, 2012. Vital Health Stat 10. 2013 Dec;(258):1-81. — View Citation

Bruzzese JM, Evans D, Kattan M. School-based asthma programs. J Allergy Clin Immunol. 2009 Aug;124(2):195-200. doi: 10.1016/j.jaci.2009.05.040. Epub 2009 Jul 16. — View Citation

Centers for Disease Control and Prevention. Asthma Data, Statistics, and Surveillance. Most Recent Asthma Data. 2017.

Centers for Disease Control and Prevention. Asthma-Related Missed School Days among Children Aged 5-17 Years.; 2015.

Christiansen SC, Martin SB, Schleicher NC, Koziol JA, Mathews KP, Zuraw BL. Evaluation of a school-based asthma education program for inner-city children. J Allergy Clin Immunol. 1997 Nov;100(5):613-7. doi: 10.1016/s0091-6749(97)70164-7. — View Citation

Cloutier MM, Hall CB, Wakefield DB, Bailit H. Use of asthma guidelines by primary care providers to reduce hospitalizations and emergency department visits in poor, minority, urban children. J Pediatr. 2005 May;146(5):591-7. doi: 10.1016/j.jpeds.2004.12.017. — View Citation

Coffman JM, Cabana MD, Halpin HA, Yelin EH. Effects of asthma education on children's use of acute care services: a meta-analysis. Pediatrics. 2008 Mar;121(3):575-86. doi: 10.1542/peds.2007-0113. — View Citation

Coffman JM, Cabana MD, Yelin EH. Do school-based asthma education programs improve self-management and health outcomes? Pediatrics. 2009 Aug;124(2):729-42. doi: 10.1542/peds.2008-2085. Epub 2009 Jul 27. — View Citation

Gerald LB, McClure LA, Mangan JM, Harrington KF, Gibson L, Erwin S, Atchison J, Grad R. Increasing adherence to inhaled steroid therapy among schoolchildren: randomized, controlled trial of school-based supervised asthma therapy. Pediatrics. 2009 Feb;123(2):466-74. doi: 10.1542/peds.2008-0499. — View Citation

Grant EN, Malone A, Lyttle CS, Weiss KB. Asthma morbidity and treatment in the Chicago metropolitan area: one decade after national guidelines. Ann Allergy Asthma Immunol. 2005 Jul;95(1):19-25. doi: 10.1016/S1081-1206(10)61183-0. — View Citation

Gupta RS, Ballesteros J, Springston EE, Smith B, Martin M, Wang E, Damitz M. The state of pediatric asthma in Chicago's Humboldt Park: a community-based study in two local elementary schools. BMC Pediatr. 2010 Jun 24;10:45. doi: 10.1186/1471-2431-10-45. — View Citation

Gupta RS, Lau CH, Warren CM, Lelchuk A, Alencar A, Springston EE, Holl JL. The impact of student-directed videos on community asthma knowledge. J Community Health. 2013 Jun;38(3):463-70. doi: 10.1007/s10900-012-9630-4. — View Citation

Gupta RS, Zhang X, Sharp LK, Shannon JJ, Weiss KB. Geographic variability in childhood asthma prevalence in Chicago. J Allergy Clin Immunol. 2008 Mar;121(3):639-645.e1. doi: 10.1016/j.jaci.2007.11.036. Epub 2008 Feb 4. — View Citation

Halterman JS, Riekert K, Bayer A, Fagnano M, Tremblay P, Blaakman S, Borrelli B. A pilot study to enhance preventive asthma care among urban adolescents with asthma. J Asthma. 2011 Jun;48(5):523-30. doi: 10.3109/02770903.2011.576741. — View Citation

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. — View Citation

Harris K, Kneale D, Lasserson TJ, McDonald VM, Grigg J, Thomas J. School-based self-management interventions for asthma in children and adolescents: a mixed methods systematic review. Cochrane Database Syst Rev. 2019 Jan 28;1(1):CD011651. doi: 10.1002/14651858.CD011651.pub2. — View Citation

Illinois Department of Public Health. The Burden of Asthma in Illinois, 2000-2011. State of Illinois; 2013.

Mattke S, Martorell F, Sharma P, Malveaux F, Lurie N. Quality of care for childhood asthma: estimating impact and implications. Pediatrics. 2009 Mar;123 Suppl 3:S199-204. doi: 10.1542/peds.2008-2233K. — View Citation

Naman J, Press VG, Vaughn D, Hull A, Erwin K, Volerman A. Student perspectives on asthma management in schools: a mixed-methods study examining experiences, facilitators, and barriers to care. J Asthma. 2019 Dec;56(12):1294-1305. doi: 10.1080/02770903.2018.1534968. Epub 2018 Oct 30. — View Citation

National Heart, Lung, and Blood Institute. Guidelines for the Diagnosis and Management of Asthma: Expert Panel Report 3. Washington, DC: US Department of Health and Human Services; 2007.

National Heart, Lung, and Blood Institute. Managing Asthma: A Guide for Schools. Washington, DC: US Department of Health and Human Services; 2014.

National Surveillance of Asthma: United States, 2001-2010. Hyattsville, MD: U.S. Dept. of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics; 2012.

Quinn K, Shalowitz MU, Berry CA, Mijanovich T, Wolf RL. Racial and ethnic disparities in diagnosed and possible undiagnosed asthma among public-school children in Chicago. Am J Public Health. 2006 Sep;96(9):1599-603. doi: 10.2105/AJPH.2005.071514. Epub 2006 Feb 28. — View Citation

Redline S, Gruchalla RS, Wolf RL, Yawn BP, Cartar L, Gan V, Nelson P, Wollan P. Development and validation of school-based asthma and allergy screening questionnaires in a 4-city study. Ann Allergy Asthma Immunol. 2004 Jul;93(1):36-48. doi: 10.1016/S1081-1206(10)61445-7. — View Citation

Volerman A, Chin MH, Press VG. Solutions for Asthma Disparities. Pediatrics. 2017 Mar;139(3):e20162546. doi: 10.1542/peds.2016-2546. Epub 2017 Feb 22. No abstract available. — View Citation

Volerman A, Dennin M, Vela M, Ignoffo S, Press VG. A qualitative study of parent perspectives on barriers, facilitators and expectations for school asthma care among urban, African-American children. J Asthma. 2019 Oct;56(10):1099-1109. doi: 10.1080/02770903.2018.1520861. Epub 2018 Oct 4. — View Citation

Volerman A, Ignoffo S, Hull A, McArthur Hanshaw S, Taylor S, Vela M, Press VG. Identification of students with asthma in Chicago schools: Missing the mark. Ann Allergy Asthma Immunol. 2017 Jun;118(6):739-740. doi: 10.1016/j.anai.2017.04.004. Epub 2017 May 4. No abstract available. — View Citation

Volerman A, Kan K, Salem E, Prachand N, Warren CM, Sighoko D, Gupta RS. Disparities persist in asthma-related emergency department visits among Chicago children. Ann Allergy Asthma Immunol. 2019 Apr;122(4):417-419.e1. doi: 10.1016/j.anai.2019.01.011. Epub 2019 Jan 24. No abstract available. — View Citation

Wheeler L, Buckley R, Gerald LB, Merkle S, Morrison TA. Working With Schools to Improve Pediatric Asthma Management. Pediatric Asthma, Allergy & Immunology. 2009;22(4):197-208.

Wheeler LS, Merkle SL, Gerald LB, Taggart VS. Managing asthma in schools: lessons learned and recommendations. J Sch Health. 2006 Aug;76(6):340-4. doi: 10.1111/j.1746-1561.2006.00125.x. No abstract available. — View Citation

Wolf FM, Guevara JP, Grum CM, Clark NM, Cates CJ. Educational interventions for asthma in children. Cochrane Database Syst Rev. 2003;(1):CD000326. doi: 10.1002/14651858.CD000326. — View Citation

Wolf RL, Berry CA, O'Connor T, Coover L. Validation of the Brief Pediatric Asthma Screen. Chest. 1999 Oct;116(4 Suppl 1):224S-228S. doi: 10.1378/chest.116.suppl_2.224s. — View Citation

Wolf RL, Berry CA, Quinn K. Development and validation of a brief pediatric screen for asthma and allergies among children. Ann Allergy Asthma Immunol. 2003 May;90(5):500-7. doi: 10.1016/S1081-1206(10)61843-1. — View Citation

* Note: There are 37 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Asthma control Childhood Asthma Control Test Years 1 and 2
Secondary Missed work days in parents Parent reports, logs Years 1 and 2
Secondary Asthma knowledge - parents Asthma Knowledge Scale Years 1 and 2
Secondary Asthma knowledge - child Asthma Knowledge Scale Years 1 and 2
Secondary Asthma quality of life - child Pediatric Asthma Quality of Life Questionnaire Years 1 and 2
Secondary Caregiver quality of life Pediatric Asthma Caregiver's Quality of Life Questionnaire Years 1 and 2
Secondary Asthma impact - parent Parent Proxy Asthma Impact Scale Years 1 and 2
Secondary Missed school days School records, parent report, logs Years 1 and 2
Secondary Healthcare utilization Parent report and logs of ambulatory visits, emergency department visits, hospitalizations Years 1 and 2
Secondary Asthma impact - child Pediatric Asthma Impact Scale Years 1 and 2
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