Clinical trial NCT01757002: Web-Based and Tailored Asthma Management Intervention (Puff City) in Teens With Asthma Attending Urban Clinics
Official title: Pragmatic Randomized Controlled Trial of the Web-Based Asthma Management Intervention (Puff City) in Teens With Asthma Attending Urban Clinics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Urban adolescents
Acute asthma
Asthma
Computer tailoring
Web-based intervention
Puff City
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: Augusta University
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2012-12-28
Enrollment: 266
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Asthma Control Test (ACT)
timeFrame: 12 Months
Secondary outcomes:
measure: Asthma Exacerbations/Functional Status
timeFrame: 12 Months
Other outcomes:
measure: The Cost
timeFrame: Up to 12 months
measure: The Cost Effectiveness
timeFrame: Up to 12 months
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
affiliation: Henry Ford Health System
name: Mei Lu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Henry Ford Health System
name: Christine Joseph, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lu M, Ownby DR, Zoratti E, Roblin D, Johnson D, Johnson CC, Joseph CL. Improving efficiency and reducing costs: Design of an adaptive, seamless, and enriched pragmatic efficacy trial of an online asthma management program. Contemp Clin Trials. 2014 May;38(1):19-27. doi: 10.1016/j.cct.2014.02.008. Epub 2014 Mar 6.