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| ID | Type | Description | Link |
|---|---|---|---|
| 1RC1HL099432-01 | 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 goal of this new translational project is to test the feasibility and effectiveness of implementing school-based directly observed therapy of preventive asthma medications in a real-world setting, using state-of-the-art web-based technology for systematic screening, electronic report generation, and communication between nurses, caregivers, and primary care providers. With the use of a novel method to improve adherence and subsequently reduce morbidity, the investigators hypothesize that this novel adaptation of school-based asthma care will; 1) be feasible and acceptable among this population and among school and community stakeholders, and 2) yield reduced asthma morbidity (symptom-free days, absenteeism, and emergency room / urgent care use for asthma care). The investigators anticipate that enhancing preventive healthcare for young urban children with asthma through partnerships with the schools using a novel technology will yield improved health, prevention of suffering, decreased absenteeism from school, and reduced healthcare costs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| School-Based Medication Group | Experimental | For children assigned to the School-Based Medication group, an asthma coordinator will send the child's primary care physician a report indicating the child's asthma symptoms, and will recommend that the child receive a preventive asthma medication at school. If the child's doctor agrees, the preventive asthma medication will be delivered to the child's school and to his/her home by a local pharmacy. The child's school nurse will begin directly observed therapy of the preventive asthma medication at school, and will routinely assess the child's asthma symptoms throughout the school year. |
|
| Usual Care Group | No Intervention | Children in the Usual Care group will not receive preventive medications delivered at school. These children will continue to receive all of their asthma care from their parents and primary care physicians. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| School-Based Medication Delivery | Other | For children assigned to the School-Based Medication group, an asthma coordinator will send the child's primary care physician a report indicating the child's asthma symptoms, and will recommend that the child receive a preventive asthma medication at school. If the child's doctor agrees, the preventive asthma medication will be delivered to the child's school and to his/her home by a local pharmacy. The child's school nurse begin directly observed therapy of the preventive asthma medication at school, and will routinely assess the child's asthma symptoms throughout the school year. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Number of Symptom-free Days Over 14 Days; (Symptom-free Days Are Averaged Over 4 Bi-monthly Follow-ups) | The primary outcome is asthma morbidity between groups. We will measure asthma morbidity by looking at the average number of symptom-free days, over 2 weeks, at each bi-monthly follow-up time point over the school year. Number of days without asthma symptoms will be reported by the child's caregiver. | Average number of days, over 2 weeks, throughout the school year |
| Measure | Description | Time Frame |
|---|---|---|
| Cost Effectiveness | We will evaluate the cost effectiveness to implement and sustain the web-based system in schools. We will review the cost of the intervention using three main categories of costs; programmatic costs (costs of initiating and running the program), productivity costs, and medical costs estimated at the individual child level. | one year |
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Inclusion Criteria (all 4 criteria must be met):
Physician-diagnosed asthma (based on parent report).
Persistent asthma (criteria based on NHLBI guidelines). Any 1 of the following:
Age ≥3 and ≤10 years.
Attending school in participating Rochester City School District preschools or elementary schools.
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 |
|---|---|---|---|---|---|---|
| Univeristy of Rochester | Rochester | New York | 14642 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22455402 | Background | Halterman JS, Sauer J, Fagnano M, Montes G, Fisher S, Tremblay P, Tajon R, Butz A. Working toward a sustainable system of asthma care: development of the School-Based Preventive Asthma Care Technology (SB-PACT) trial. J Asthma. 2012 May;49(4):395-400. doi: 10.3109/02770903.2012.669441. Epub 2012 Mar 28. | |
| 22785264 | Result | Halterman JS, Fagnano M, Montes G, Fisher S, Tremblay P, Tajon R, Sauer J, Butz A. The school-based preventive asthma care trial: results of a pilot study. J Pediatr. 2012 Dec;161(6):1109-15. doi: 10.1016/j.jpeds.2012.05.059. Epub 2012 Jul 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | School-Based Medication Group | For children assigned to the School-Based Medication group, an asthma coordinator will send the child's primary care physician a report indicating the child's asthma symptoms, and will recommend that the child receive a preventive asthma medication at school. If the child's doctor agrees, the preventive asthma medication will be delivered to the child's school and to his/her home by a local pharmacy. The child's school nurse will begin directly observed therapy of the preventive asthma medication at school, and will routinely assess the child's asthma symptoms throughout the school year. |
| FG001 | Usual Care Group | Children in the Usual Care group will not receive preventive medications delivered at school. These children will continue to receive all of their asthma care from their parents and primary care physicians. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | School-Based Medication Group | For children assigned to the School-Based Medication group, an asthma coordinator will send the child's primary care physician a report indicating the child's asthma symptoms, and will recommend that the child receive a preventive asthma medication at school. If the child's doctor agrees, the preventive asthma medication will be delivered to the child's school and to his/her home by a local pharmacy. The child's school nurse will begin directly observed therapy of the preventive asthma medication at school, and will routinely assess the child's asthma symptoms throughout the school year. |
| 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 | Average Number of Symptom-free Days Over 14 Days; (Symptom-free Days Are Averaged Over 4 Bi-monthly Follow-ups) | The primary outcome is asthma morbidity between groups. We will measure asthma morbidity by looking at the average number of symptom-free days, over 2 weeks, at each bi-monthly follow-up time point over the school year. Number of days without asthma symptoms will be reported by the child's caregiver. | Posted | Mean | Standard Deviation | Days | Average number of days, over 2 weeks, throughout the school 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 | School-Based Medication Group | For children assigned to the School-Based Medication group, an asthma coordinator will send the child's primary care physician a report indicating the child's asthma symptoms, and will recommend that the child receive a preventive asthma medication at school. If the child's doctor agrees, the preventive asthma medication will be delivered to the child's school and to his/her home by a local pharmacy. The child's school nurse will begin directly observed therapy of the preventive asthma medication at school, and will routinely assess the child's asthma symptoms throughout the school year. |
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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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|
| Feasibility and Acceptability | We will conduct interviews with parents and school nurses to evaluate whether this new program is feasible and acceptable among this population. | one year |
| BG001 | Usual Care Group | Children in the Usual Care group will not receive preventive medications delivered at school. These children will continue to receive all of their asthma care from their parents and primary care physicians. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Usual Care Group | Children in the Usual Care group will not receive preventive medications delivered at school. These children will continue to receive all of their asthma care from their parents and primary care physicians. |
|
|
| Secondary | Cost Effectiveness | We will evaluate the cost effectiveness to implement and sustain the web-based system in schools. We will review the cost of the intervention using three main categories of costs; programmatic costs (costs of initiating and running the program), productivity costs, and medical costs estimated at the individual child level. | Not Posted | one year |
| Secondary | Feasibility and Acceptability | We will conduct interviews with parents and school nurses to evaluate whether this new program is feasible and acceptable among this population. | Not Posted | one year |
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | Usual Care Group | Children in the Usual Care group will not receive preventive medications delivered at school. These children will continue to receive all of their asthma care from their parents and primary care physicians. | 0 | 51 | 0 | 51 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |