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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001412 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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Project ASTHMA is a school-based health center intervention program that institutes guideline-based chronic asthma care and provides supervised administration with daily preventive asthma medications to improve asthma symptoms and lung function, reduce emergency visits, and decrease missed days of school among children from communities with health disparities.
Project ASTHMA in schools is a 7 month randomized control intervention pilot trial. Forty students, ages 4 to 14 years, with persistent asthma, or who utilize acute care facilities frequently for their asthma, will be recruited from 3 urban SBHCs in the fall of 2018. All students will receive NHLBI guideline-based asthma assessments to determine eligibility and proper dosing of preventive medication. The asthma assessment will include spirometry testing. All enrolled students and parents will receive asthma education at the time of enrollment. Eligible students will be randomized to an intervention or usual care group using permuted block randomization stratified by SBHCs. In collaboration with the student's PCP, the SBHCs' mid-level providers will prescribe the preventive medication to the students in the intervention group. These students will receive the morning dose of their preventive medication from the school nurse each school day for the remainder of the school year. Students and their parents will be responsible to administer the evening and non-school day doses. Students randomized to the usual care group will be referred back to their PCP for further asthma management. All participants will be re-evaluated at 1, 3 and 7 months after enrollment, and medication dose adjustments will be made in the intervention group as needed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | All participants will undergo an initial asthma assessment per the NAEPP-EPR3 (National Asthma Education and Prevention Program - Expert Panel Report 3) guidelines, as well as asthma education. Participants randomized to the intervention group will be prescribed the appropriate asthma therapy based on their assessment (i.e. providing 'asthma assessment & management'), and receive the morning dose of their daily asthma controller medication at school on school days. |
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| Usual Care | Active Comparator | All participants will undergo an initial asthma assessment per the NAEPP-EPR3 (National Asthma Education and Prevention Program - Expert Panel Report 3) guidelines, as well as asthma education. Participants randomized to the usual care group will be provided with the results of their asthma assessment and be instructed to follow up with their primary care provider. They will continue to receive all of their daily asthma controller medication at home. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asthma Assessment & Management | Other | Asthma Assessment & Management based on NAEPP-EPR3 guidelines |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Number of Days Per Week, in the Previous 4 Weeks, of Daytime Asthma Symptoms From Baseline to 7-month Follow-up | Total number of days per week, over the previous 4 weeks, of asthma symptoms Minimum: 0 Maximum: 7 Lower number indicates improvement The change in number of days per week of asthma symptoms from baseline to 7-month follow-up | Baseline, 1-month, 3-month, 5-month, 7-month |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ACT Score From Baseline to 7-month Follow-up | Improvement in ACT (Asthma Control Test) score, a validated questionnaire for the assessment of asthma symptoms, which is included in the NAEPP-EPR3 guidelines for components of control. Minimum value is 0. Maximum value is 27. Higher scores mean a better outcome. Scores less than 19 suggest not well-controlled asthma. The change in ACT score from baseline to 7-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lucy C Holmes, MD, MPH | University at Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John R. Oishei Children's Hospital | Buffalo | New York | 14203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33322963 | Derived | Holmes LC, Orom H, Lehman HK, Lampkin S, Halterman JS, Akiki V, Supernault-Sarker AA, Butler SB, Piechowski D, Sorrentino PM, Chen Z, Wilding GE. A pilot school-based health center intervention to improve asthma chronic care in high-poverty schools. J Asthma. 2022 Mar;59(3):523-535. doi: 10.1080/02770903.2020.1864823. Epub 2021 Jan 6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | All participants will undergo an initial asthma assessment per the NAEPP-EPR3 (National Asthma Education and Prevention Program - Expert Panel Report 3) guidelines, as well as asthma education. Participants randomized to the intervention group will be prescribed the appropriate asthma therapy based on their assessment (i.e. providing 'asthma assessment & management'), and receive the morning dose of their daily asthma controller medication at school on school days. Asthma Assessment & Management: Asthma Assessment & Management based on NAEPP-EPR3 guidelines Asthma Education: Asthma education on medications Controller medication at school: Students will receive the morning dose of their daily preventive asthma medication at school on school days. |
| FG001 | Usual Care | All participants will undergo an initial asthma assessment per the NAEPP-EPR3 (National Asthma Education and Prevention Program - Expert Panel Report 3) guidelines, as well as asthma education. Participants randomized to the usual care group will be provided with the results of their asthma assessment and be instructed to follow up with their primary care provider. They will continue to receive all of their daily asthma controller medication at home. Asthma Assessment & Management: Asthma Assessment & Management based on NAEPP-EPR3 guidelines Asthma Education: Asthma education on medications |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | All participants will undergo an initial asthma assessment per the NAEPP-EPR3 (National Asthma Education and Prevention Program - Expert Panel Report 3) guidelines, as well as asthma education. Participants randomized to the intervention group will be prescribed the appropriate asthma therapy based on their assessment (i.e. providing 'asthma assessment & management'), and receive the morning dose of their daily asthma controller medication at school on school days. Asthma Assessment & Management: Asthma Assessment & Management based on NAEPP-EPR3 guidelines Asthma Education: Asthma education on medications Controller medication at school: Students will receive the morning dose of their daily preventive asthma medication at school on school days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Number of Days Per Week, in the Previous 4 Weeks, of Daytime Asthma Symptoms From Baseline to 7-month Follow-up | Total number of days per week, over the previous 4 weeks, of asthma symptoms Minimum: 0 Maximum: 7 Lower number indicates improvement The change in number of days per week of asthma symptoms from baseline to 7-month follow-up | Posted | Mean | 95% Confidence Interval | days per week | Baseline, 1-month, 3-month, 5-month, 7-month |
|
1 year
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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 | Intervention | All participants will undergo an initial asthma assessment per the NAEPP-EPR3 (National Asthma Education and Prevention Program - Expert Panel Report 3) guidelines, as well as asthma education. Participants randomized to the intervention group will be prescribed the appropriate asthma therapy based on their assessment (i.e. providing 'asthma assessment & management'), and receive the morning dose of their daily asthma controller medication at school on school days. Asthma Assessment & Management: Asthma Assessment & Management based on NAEPP-EPR3 guidelines Asthma Education: Asthma education on medications Controller medication at school: Students will receive the morning dose of their daily preventive asthma medication at school on school days. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lucy C Holmes, MD, MPH | University at Buffalo | 7163230034 | LHolmes@upa.chob.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 16, 2019 | May 12, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Parent | Jul 19, 2018 | May 16, 2025 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Assent - 14 years old | Jun 26, 2018 | May 16, 2025 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Assent - 7-13 yrs old | Jun 26, 2018 | May 16, 2025 | ICF_003.pdf |
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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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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Intervention group will receive the morning dose of their daily preventive asthma medication at school. The student & family will be responsible to administer the evening dose & both doses on non-school days.
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| Asthma Education | Other | Asthma education on medications |
|
| Controller medication at school | Other | Students will receive the morning dose of their daily preventive asthma medication at school on school days. |
|
| Baseline, 1-month, 3-month, 5-month, 7-month |
| Change in FEV1/FVC Ratio From Baseline to 7-month Follow-up | Improvement FEV1/FVC ratio on spirometry. Higher number is a better outcome. FEV1/FVC ratio is a calculation used in pulmonary function testing to help diagnose lung conditions, particularly obstructive and restrictive lung diseases. It represents the proportion of air a person can exhale in the first second of a forced expiration (FEV1 - forced expiratory volume in 1 second) compared to the total amount of air they can exhale with maximal effort (FVC - forced vital capacity). The change in FEV1/FVC ratio from baseline to 7-month follow-up. | Baseline, 1-month, 3-month, 5-month, 7-month |
| BG001 | Usual Care | All participants will undergo an initial asthma assessment per the NAEPP-EPR3 (National Asthma Education and Prevention Program - Expert Panel Report 3) guidelines, as well as asthma education. Participants randomized to the usual care group will be provided with the results of their asthma assessment and be instructed to follow up with their primary care provider. They will continue to receive all of their daily asthma controller medication at home. Asthma Assessment & Management: Asthma Assessment & Management based on NAEPP-EPR3 guidelines Asthma Education: Asthma education on medications |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Asthma Control Test (ACT) | Asthma Control Test (ACT) ACT test is a screening tool to assess how well controlled a patient's asthma is Minimum: 0 Maximum: 27 Higher scores are better. Scores less than 19 are considered not well controlled asthma | Mean | Standard Deviation | units on a scale |
|
| OG001 | Usual Care | All participants will undergo an initial asthma assessment per the NAEPP-EPR3 (National Asthma Education and Prevention Program - Expert Panel Report 3) guidelines, as well as asthma education. Participants randomized to the usual care group will be provided with the results of their asthma assessment and be instructed to follow up with their primary care provider. They will continue to receive all of their daily asthma controller medication at home. Asthma Assessment & Management: Asthma Assessment & Management based on NAEPP-EPR3 guidelines Asthma Education: Asthma education on medications |
|
|
| Secondary | Change in ACT Score From Baseline to 7-month Follow-up | Improvement in ACT (Asthma Control Test) score, a validated questionnaire for the assessment of asthma symptoms, which is included in the NAEPP-EPR3 guidelines for components of control. Minimum value is 0. Maximum value is 27. Higher scores mean a better outcome. Scores less than 19 suggest not well-controlled asthma. The change in ACT score from baseline to 7-month follow-up | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline, 1-month, 3-month, 5-month, 7-month |
|
|
|
| Secondary | Change in FEV1/FVC Ratio From Baseline to 7-month Follow-up | Improvement FEV1/FVC ratio on spirometry. Higher number is a better outcome. FEV1/FVC ratio is a calculation used in pulmonary function testing to help diagnose lung conditions, particularly obstructive and restrictive lung diseases. It represents the proportion of air a person can exhale in the first second of a forced expiration (FEV1 - forced expiratory volume in 1 second) compared to the total amount of air they can exhale with maximal effort (FVC - forced vital capacity). The change in FEV1/FVC ratio from baseline to 7-month follow-up. | Posted | Mean | 95% Confidence Interval | ratio | Baseline, 1-month, 3-month, 5-month, 7-month |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Usual Care | All participants will undergo an initial asthma assessment per the NAEPP-EPR3 (National Asthma Education and Prevention Program - Expert Panel Report 3) guidelines, as well as asthma education. Participants randomized to the usual care group will be provided with the results of their asthma assessment and be instructed to follow up with their primary care provider. They will continue to receive all of their daily asthma controller medication at home. Asthma Assessment & Management: Asthma Assessment & Management based on NAEPP-EPR3 guidelines Asthma Education: Asthma education on medications | 0 | 16 | 0 | 16 | 0 | 16 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |