Tailored Asthma Management for Urban Teens

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Behavioral: Generic web-based asthma education; Behavioral: Tailored Web-based Asthma Management

• Registration Number: NCT00201058
• Lead Sponsor: Henry Ford Health System

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2005-09-16
• Study First Submitted QC: 2005-09-16
• Study First Posted: 2005-09-20
• Study Start: 2006-07
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-18
• Last Update Posted: 2012-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• A physician diagnosis of asthma AND recent asthma symptoms, health care utilization for asthma, and/or use of medication (or refills of medication) to alleviate asthma symptoms OR
• No physician diagnosis of asthma AND positive responses to items selected from the International Study of Asthma and Allergy in Children (ISAAC) survey AND asthma symptoms similar to those used in the Expert Panel II for classification of mild intermittent asthma

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Exclusion Criteria

• Does not meet asthma symptom criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Generic web-based asthma education	Control students receive existing web-based, generic asthma education
1	Tailored Web-based Asthma Management	Receives tailored web-based program

Primary Outcome Measures

Name	Time	Method
Asthma-related morbidity	Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest

Secondary Outcome Measures

Name	Time	Method
Symptom-days	Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest
Symptom-nights	Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest
School days missed	Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest
Days of restricted activity	Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest

Trial Locations

Locations (1)

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States