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Tailored Asthma Management for Urban Teens (Puff City)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Christine Joseph, Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT00201058
First received: September 16, 2005
Last updated: December 18, 2012
Last verified: December 2012

September 16, 2005
December 18, 2012
July 2006
June 2010   (final data collection date for primary outcome measure)
Asthma-related morbidity [ Time Frame: Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00201058 on ClinicalTrials.gov Archive Site
  • Symptom-days [ Time Frame: Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest ] [ Designated as safety issue: No ]
  • Symptom-nights [ Time Frame: Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest ] [ Designated as safety issue: No ]
  • School days missed [ Time Frame: Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest ] [ Designated as safety issue: No ]
  • Days of restricted activity [ Time Frame: Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Tailored Asthma Management for Urban Teens
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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Asthma
  • Behavioral: Tailored Web-based Asthma Management
    Web-based asthma management
  • Behavioral: Generic web-based asthma education
    4 computer sessions over a period of 180 days
  • Experimental: 1
    Receives tailored web-based program
    Intervention: Behavioral: Tailored Web-based Asthma Management
  • Active Comparator: 2
    Control students receive existing web-based, generic asthma education
    Intervention: Behavioral: Generic web-based asthma education

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
450
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
14 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00201058
1299, R01HL068971-04, R01 HL068971
Yes
Christine Joseph, Henry Ford Health System
Henry Ford Health System
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Christine Joseph, PhD Henry Ford Health System
Henry Ford Health System
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP