| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL079954-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Halcyon Hill Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Cotinine Level | 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 month and approximately 9 month (end of school year) follow-up assessments |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jill S. Halterman, MD, MPH | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18446591 | Background | 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. | |
| 19564303 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Usual asthma care |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Usual asthma care |
| BG001 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | Days | Average Symptom Free Days, over 2 weeks, during peak asthma season (November-February) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Usual asthma care |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jill Halterman | University of Rochester | 5852755798 | jill_halterman@urmc.rochester.edu |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Cost Effectiveness of the Intervention |
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. |
| approximately 9 months (length of school year) |
| Additional Asthma Morbidity Outcomes | 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. | 1-9 months (Monthly Follow-up assessments) |
| 19329093 | Background | 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. |
| 19047246 | Background | 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. |
| 19796913 | Background | 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. |
| 19233588 | Background | 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. |
| 18922501 | Background | 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. |
| 21816697 | Background | 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. |
| 21911409 | Background | 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. |
| 22717938 | Background | 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. |
| 23400614 | Background | 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. |
| 24619226 | Background | 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. |
| 24528997 | Background | 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. |
| 21383275 | Result | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Cotinine Level | 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). | Not Posted | 2 month and approximately 9 month (end of school year) follow-up assessments |
| Secondary | Cost Effectiveness of the Intervention | 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. | Not Posted | approximately 9 months (length of school year) |
| Secondary | Additional Asthma Morbidity Outcomes | 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. | Not Posted | 1-9 months (Monthly Follow-up assessments) |
| 0 |
| 265 |
| 0 |
| 265 |
| EG001 | 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). | 0 | 265 | 0 | 265 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |