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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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The goal of this pilot study is to implement directly observed therapy with preventive asthma medications through a partnership with the school nurse (with input and direction from the primary care provider) to assure that the teen receives guideline based preventive medications, and provide a motivational interviewing intervention to help the teen transition to independence with their medical treatment plan. We hypothesize that this community-based pilot intervention will; 1) be feasible and acceptable among this population and among school personnel, and 2) yield reduced asthma morbidity (symptom-free days, absenteeism, and emergency room / urgent care use for asthma care). We anticipate that enhancing preventive healthcare for urban teens with asthma through partnerships with schools will yield improved health, prevention of suffering, decreased absenteeism from school, and reduced healthcare costs. This new method of preventive care delivery could be sustained within the school nursing system, and could be implemented in schools nationwide. Further, it could be applied to other chronic illnesses affecting disadvantaged populations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Teens participating in this study will have:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention | Behavioral | Teens participating in this study will have:
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Symptom-free Days Over Two Weeks | We will measure number of symptom-free days at 2-months (at the end of the directly observed therapy phase) and 4-months (after their transition to independence with preventive medications). We anticipate that teens will experience more symptom-free days compared to baseline assessment. | 2 and 4 month follow-up assessments |
| Measure | Description | Time Frame |
|---|---|---|
| Additional Asthma Morbidity Measures | We also will compare additional baseline asthma morbidity measures, quality of life, health care utilization, cotinine, and exhaled nitric oxide with outcomes at the follow-up assessments. | 2 month, 4 month, final 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 |
|---|---|---|---|
| 24494626 | Background | Blaakman SW, Cohen A, Fagnano M, Halterman JS. Asthma medication adherence among urban teens: a qualitative analysis of barriers, facilitators and experiences with school-based care. J Asthma. 2014 Jun;51(5):522-9. doi: 10.3109/02770903.2014.885041. Epub 2014 Feb 7. | |
| 21599562 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Teens participating in this study will have:
|
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Teens participating in this study will have:
|
| 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 Over Two Weeks | We will measure number of symptom-free days at 2-months (at the end of the directly observed therapy phase) and 4-months (after their transition to independence with preventive medications). We anticipate that teens will experience more symptom-free days compared to baseline assessment. | Analysis conducted per protocol. | Posted | Mean | Standard Deviation | Days | 2 and 4 month follow-up assessments |
|
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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 | Teens participating in this study will have:
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria Fagnano | University of Rochester | 5852758220 | maria_fagnano@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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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Additional Asthma Morbidity Measures | We also will compare additional baseline asthma morbidity measures, quality of life, health care utilization, cotinine, and exhaled nitric oxide with outcomes at the follow-up assessments. | Not Posted | 2 month, 4 month, final follow-up assessments |
| 0 |
| 30 |
| 0 |
| 30 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |