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Tailored Asthma Management for Urban Teens (Puff City)

Henry Ford Health logo

Henry Ford Health

Status

Completed

Conditions

Asthma

Treatments

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

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00201058
R01HL068971 (U.S. NIH Grant/Contract)
1299
R01HL068971-04 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

450 patients

Sex

All

Ages

14 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

450 participants in 2 patient groups

1
Experimental group
Description:
Receives tailored web-based program
Treatment:
Behavioral: Tailored Web-based Asthma Management
2
Active Comparator group
Description:
Control students receive existing web-based, generic asthma education
Treatment:
Behavioral: Generic web-based asthma education

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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