A Pilot Study to Improve Preventive Asthma Care for Urban Adolescents

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Study to Improve Preventive Asthma Care for Urban Adolescents

Conditions
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Asthma

Intervention / Treatment
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* Behavioral: Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Physician-diagnosed asthma Persistent asthma (criteria based on NHLBI guidelines). Age >12 and <15 years. Attending school in the Rochester City School District. Signed physician permission to enroll the child. Current prescription of a daily preventive asthma medication Parent or caregiver and the adolescent must consent to the intervention. Exclusion Criteria: Inability to speak and understand English. No access to a working phone for follow-up surveys The family planning to leave the school district within fewer than 6 months. The teen having other significant medical conditions The teen having a diagnosed developmental condition per parent report. Adolescents in foster care or other situations in which consent cannot be obtained from a guardian. Adolescents that were previously enrolled in our School-Based Asthma Study

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Teens participating in this study will have: directly observed administration of their daily preventive asthma medication at school, by the school nurse, for the first 6-8 weeks of the study three counseling sessions with a study nurse trained in principles of motivational interviewing (MI), that are designed to enhance the teen's motivation to change health behaviors, with a focus on adherence to evidence-based preventive care guidelines (e.g.; preventive medications). | Behavioral: Intervention<br>* Teens participating in this study will have: directly observed administration of their daily preventive asthma medication at school, by the school nurse, for the first 6-8 weeks of the study three counseling sessions with a study nurse trained in principles of motivational interviewing (MI), that are designed to enhance the teen's motivation to change health behaviors, with a focus on adherence to evidence-based preventive care guidelines (e.g.; preventive medications).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma