Web-Based and Tailored Asthma Management Intervention (Puff City) in Teens With Asthma Attending Urban Clinics

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Behavioral: Teens randomized to the experimental arm will receive 4 sessions plus a booster of web-based, tailored asthma management.; Behavioral: Teens in the control group will receive generic, web-based asthma education.

• Registration Number: NCT01757002
• Lead Sponsor: Henry Ford Health System

Brief Summary

The purpose of this study is to evaluate the Puff City web-based behavioral intervention of asthma management program in a clinical setting. This study also examines and evaluates the cost and efficiency of patient eligibility determination methods, patient recruitment, study monitoring (compliance with study regimen, participant retention and follow-up), and the collection of clinical endpoints.

Detailed Description

Asthma continues to be a major public health problem in the US with high economic and social costs. Vulnerable ethnic communities are disproportionately affected by asthma as demonstrated by higher morbidity and mortality for these groups. We have completed two school-based, randomized trials of a web-based, computer-tailored asthma management intervention that targets urban teens (Puff City).

The current study, Puff City in the Clinic, will be evaluated as a clinical tool by initiating the web-based behavioral intervention of asthma management in a clinical setting. However, the current paradigm for conducting such a trial is costly with respect to patient recruitment, intervention delivery, and data collection and management. To address these high costs, the study utilizes comparative effectiveness research (CER) pragmatic approaches to design a randomized controlled trial for patient recruitment and determination of eligibility, study monitoring (compliance with study regimen, participant retention and follow-up), and collection of clinical endpoints.

Study Timeline

• Study First Submitted: 2012-12-07
• Study First Submitted QC: 2012-12-27
• Study First Posted: 2012-12-28
• Study Start: 2013-03
• Primary Completion: 2015-05
• Study Completion: 2016-11
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-08
• Last Update Posted: 2017-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 266

Inclusion Criteria

• 13-19 years of age

• Must be able to provide electronic assent and have consent from a parent/guardian if applicable

• Diagnosis of asthma by meeting one of the following criteria within the last 12 months:

  • At least one emergency department diagnosis of asthma or
  • At least one acute inpatient encounter with asthma as the principal diagnosis or
  • At least four outpatient visits with an asthma diagnosis and at least 2 asthma medications dispensed or
  • At least four asthma medications dispensed

Exclusion Criteria

• Inability to provide informed consent/assent
• Lack of physician diagnosis of asthma
• Other co-morbidities that make it impossible for the individual to participate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tailored asthma management program	Teens randomized to the experimental arm will receive 4 sessions plus a booster of web-based, tailored asthma management.	Teens randomized to the experimental arm will receive 4 sessions plus a booster of web-based, tailored asthma management.
Control	Teens in the control group will receive generic, web-based asthma education.	Teens in the control group will receive generic, web-based asthma education.

Primary Outcome Measures

Name	Time	Method
Asthma Control Test (ACT)	12 Months	Comparison of ACT scores at 12 months after the randomization

Secondary Outcome Measures

Name	Time	Method
Asthma Exacerbations/Functional Status	12 Months	Comparison of asthma exacerbations (asthma hospitalizations, emergency department visits, or oral corticosteroid dispensing)and functional status(e.g. self report of symptom-days, symptom nights, days of restricted activity, school/work days missed) at 12 months after randomization.

Trial Locations

Locations (1)

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States