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Completed

NCT Number: NCT00201058

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.

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Key information

Age range

14 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henry Ford Health System

Detroit, Michigan, 48202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

  • Does not meet asthma symptom criteria

Treatment and study plan

Tailored Web-based Asthma Management

Behavioral

Web-based asthma management

Generic web-based asthma education

Behavioral

4 computer sessions over a period of 180 days

Primary outcomes

  1. Asthma-related morbidity

    Time frame: Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest

Secondary outcomes

  1. Symptom-days

    Time frame: Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest

  2. Symptom-nights

    Time frame: Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest

  3. School days missed

    Time frame: Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest

  4. Days of restricted activity

    Time frame: Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: Puff City

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Sep 20, 2005
Registry last updated
Dec 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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