Asthma Clinical Trial
Official title:
Tailored Asthma Management for Urban Teens
The purpose of this project is to refine and further evaluate an online asthma management and education program for urban teenagers. This project is a continuation of Puff City I, a project piloting and evaluating a tailored, school-based, computerized asthma education program for urban teenagers. In this second phase of research, a new version of software (Puff City II) will be created that will target resistance to change and relapse, and using a tested, theory-based approach to student recruitment, conduct a randomized trial to test the efficacy of this new software.
BACKGROUND:
Teenagers are among an age group that has seen dramatic increases in deaths from asthma. In
Detroit, asthma death rates for teenagers are high relative to younger ages, despite a
higher prevalence in the latter age group. Early studies suggest that inadequate asthma
management plays a significant role in these grim statistics.
DESIGN NARRATIVE:
The study hypothesis is that students randomized to the intervention group will have lower
asthma-related morbidity as determined by fewer emergency department visits and
hospitalizations at the time of the 12-month follow-up. Based on a second hypothesis of
better functional status among students randomized to the intervention group, secondary
outcomes include fewer symptom-days, symptom-nights, school days missed, and days of
restricted activity at the time of the 12-month follow-up. In addition, it is hypothesized
that students in the intervention group will have higher scores on the Juniper Pediatric
Quality of Life scale at 12 months. Finally, it is hypothesized that intervention students
would exhibit positive changes in adherence behavior, having a rescue inhaler nearby, and
smoking at the 12-month follow-up.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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