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| ID | Type | Description | Link |
|---|---|---|---|
| 1R18HL110858 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The investigators hypothesize that school-based, direct supervision of daily controller therapy will result in more effective asthma control, as assessed by the Asthma Control Questionnaire than usual care. Additionally, as the result of enhanced asthma control and resulting decrease in health care utilization, school-based, direct supervision of daily controller therapy will result in lower cost per quality-adjusted life year (QALY) gained than usual care.
This research is being done to test if children with asthma will have fewer asthma symptoms if they are monitored at school to make sure they take their inhaled steroid medication (ICS) every day and take the medication the right way. All of the children with asthma in the school will be asked to participate. In the first year in one-half of the schools, children and school staff will participate in a standardized asthma education program presented by the American Lung Association (ALA). Children will have daily monitoring of their inhaled asthma medication. The other half of schools will continue with the usual treatment of children with asthma. In the second year of the study, all schools and children will have the asthma education program and monitoring. Parents will be queried quarterly for information about their child's asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regular Therapy | No Intervention | Regular Asthma Therapy | |
| Supervised Therapy | Experimental | Supervised asthma therapy in schools |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supervised asthma therapy in schools | Drug | Therapy observed daily in school. Asthma education by American Lung Association |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ) | An ACQ score of > 1.5 means asthma is not well controlled. An ACQ score of <= 1.5 means asthma is well controlled. Missing ACQ score = number of participants not administered an ACQ | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lynn B Gerald, Ph.D., MSPH | University of Arizona, Mel and Enid Zuckerman College of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Arizona and the Tucson Unified School District | Tucson | Arizona | 85724 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30118728 | Derived | Gerald JK, Fisher JM, Brown MA, Clemens CJ, Moore MA, Carvajal SC, Bryson D, Stefan N, Billheimer D, Gerald LB. School-supervised use of a once-daily inhaled corticosteroid regimen: A cluster randomized trial. J Allergy Clin Immunol. 2019 Feb;143(2):755-764. doi: 10.1016/j.jaci.2018.06.048. Epub 2018 Aug 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Regular Therapy | Regular Asthma Therapy |
| FG001 | Supervised Therapy | Supervised asthma therapy in schools Supervised asthma therapy in schools: Therapy observed daily in school. Asthma education by American Lung Association |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Regular Therapy | Regular Asthma Therapy |
| BG001 | Supervised Therapy | Supervised asthma therapy in schools Supervised asthma therapy in schools: Therapy observed daily in school. Asthma education by American Lung Association |
| 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 | The Primary Outcome Will be the Score on the Juniper Asthma Control Questionnaire (ACQ) | An ACQ score of > 1.5 means asthma is not well controlled. An ACQ score of <= 1.5 means asthma is well controlled. Missing ACQ score = number of participants not administered an ACQ | Posted | Count of Participants | Participants | 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 | Regular Therapy | Regular Asthma Therapy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clara Ehrman | University of Arizona | 520-621-5439 | csehrman@email.arizona.edu |
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| ID | Term |
|---|---|
| D012574 | Schools |
| D000420 | Albuterol |
| ID | Term |
|---|---|
| D000072182 | Non-Medical Public and Private Facilities |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
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| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 192 |
| 0 |
| 192 |
| EG001 | Supervised Therapy | Supervised asthma therapy in schools Supervised asthma therapy in schools: Therapy observed daily in school. Asthma education by American Lung Association | 0 | 250 | 0 | 250 |
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| D009930 |
| Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| missing ACQ score |
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| missing ACQ score |
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| missing ACQ score |
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