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Tailored Asthma Management for Urban Teens (Puff City)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00201058
First Posted: September 20, 2005
Last Update Posted: December 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Christine Joseph, Henry Ford Health System
  Purpose
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.

Condition Intervention
Asthma Behavioral: Tailored Web-based Asthma Management Behavioral: Generic web-based asthma education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tailored Asthma Management for Urban Teens

Resource links provided by NLM:


Further study details as provided by Christine Joseph, Henry Ford Health System:

Primary Outcome Measures:
  • Asthma-related morbidity [ Time Frame: Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest ]

Secondary Outcome Measures:
  • Symptom-days [ Time Frame: Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest ]
  • Symptom-nights [ Time Frame: Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest ]
  • School days missed [ Time Frame: Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest ]
  • Days of restricted activity [ Time Frame: Measured at baseline, 6 months, and 12 months with the latter being the timepoint of interest ]

Enrollment: 450
Study Start Date: July 2006
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Receives tailored web-based program
Behavioral: Tailored Web-based Asthma Management
Web-based asthma management
Active Comparator: 2
Control students receive existing web-based, generic asthma education
Behavioral: Generic web-based asthma education
4 computer sessions over a period of 180 days

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00201058


Locations
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Christine Joseph, PhD Henry Ford Health System
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christine Joseph, Senior Scientist, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT00201058     History of Changes
Other Study ID Numbers: 1299
R01HL068971-04 ( U.S. NIH Grant/Contract )
R01HL068971 ( U.S. NIH Grant/Contract )
First Submitted: September 16, 2005
First Posted: September 20, 2005
Last Update Posted: December 20, 2012
Last Verified: December 2012

Keywords provided by Christine Joseph, Henry Ford Health System:
urban
adolescents
African American
web-based
computer tailoring
school based

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases