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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tailored Asthma Management for Urban Teens

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   14 Years to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00201058

Locations
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
Investigators
Principal Investigator: Christine Joseph, PhD Henry Ford Health System
  More Information

Publications:
Additional 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, R01 HL068971
Study First Received: September 16, 2005
Last Updated: December 18, 2012
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on October 20, 2014