Web-Based and Tailored Asthma Management Intervention (Puff City) in Teens With Asthma Attending Urban Clinics

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the Puff City web-based behavioral intervention of asthma management program in a clinical setting. This study also examines and evaluates the cost and efficiency of patient eligibility determination methods, patient recruitment, study monitoring (compliance with study regimen, participant retention and follow-up), and the collection of clinical endpoints.

Detailed Description
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Asthma continues to be a major public health problem in the US with high economic and social costs. Vulnerable ethnic communities are disproportionately affected by asthma as demonstrated by higher morbidity and mortality for these groups. We have completed two school-based, randomized trials of a web-based, computer-tailored asthma management intervention that targets urban teens (Puff City). The current study, Puff City in the Clinic, will be evaluated as a clinical tool by initiating the web-based behavioral intervention of asthma management in a clinical setting. However, the current paradigm for conducting such a trial is costly with respect to patient recruitment, intervention delivery, and data collection and management. To address these high costs, the study utilizes comparative effectiveness research (CER) pragmatic approaches to design a randomized controlled trial for patient recruitment and determination of eligibility, study monitoring (compliance with study regimen, participant retention and follow-up), and collection of clinical endpoints.

Official Title
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Pragmatic Randomized Controlled Trial of the Web-Based Asthma Management Intervention (Puff City) in Teens With Asthma Attending Urban Clinics

Conditions
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Asthma

Intervention / Treatment
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* Behavioral: Teens randomized to the experimental arm will receive 4 sessions plus a booster of web-based, tailored asthma management.
* Behavioral: Teens in the control group will receive generic, web-based asthma education.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 13-19 years of age Must be able to provide electronic assent and have consent from a parent/guardian if applicable Diagnosis of asthma by meeting one of the following criteria within the last 12 months: At least one emergency department diagnosis of asthma or At least one acute inpatient encounter with asthma as the principal diagnosis or At least four outpatient visits with an asthma diagnosis and at least 2 asthma medications dispensed or At least four asthma medications dispensed Exclusion Criteria: Inability to provide informed consent/assent Lack of physician diagnosis of asthma Other co-morbidities that make it impossible for the individual to participate.

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 19 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tailored asthma management program<br>Teens randomized to the experimental arm will receive 4 sessions plus a booster of web-based, tailored asthma management. | Behavioral: Teens randomized to the experimental arm will receive 4 sessions plus a booster of web-based, tailored asthma management.<br>* Web-based, computer-tailored asthma management intervention delivered in 4 sessions, plus a 6 month booster.<br>|
| Active Comparator: Control<br>Teens in the control group will receive generic, web-based asthma education. | Behavioral: Teens in the control group will receive generic, web-based asthma education.<br>* Web-based, generic asthma management intervention delivered in 4 sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Control Test (ACT) | Comparison of ACT scores at 12 months after the randomization | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Exacerbations/Functional Status | Comparison of asthma exacerbations (asthma hospitalizations, emergency department visits, or oral corticosteroid dispensing)and functional status(e.g. self report of symptom-days, symptom nights, days of restricted activity, school/work days missed) at 12 months after randomization. | 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urban adolescents, Acute asthma, Asthma, Computer tailoring, Web-based intervention, Puff City