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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

266 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2016-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Tailored asthma management program

Teens randomized to the experimental arm will receive 4 sessions plus a booster of web-based, tailored asthma management.

Group Type EXPERIMENTAL

Teens randomized to the experimental arm will receive 4 sessions plus a booster of web-based, tailored asthma management.

Intervention Type BEHAVIORAL

Web-based, computer-tailored asthma management intervention delivered in 4 sessions, plus a 6 month booster.

Control

Teens in the control group will receive generic, web-based asthma education.

Group Type ACTIVE_COMPARATOR

Teens in the control group will receive generic, web-based asthma education.

Intervention Type BEHAVIORAL

Web-based, generic asthma management intervention delivered in 4 sessions.

Interventions

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Teens randomized to the experimental arm will receive 4 sessions plus a booster of web-based, tailored asthma management.

Web-based, computer-tailored asthma management intervention delivered in 4 sessions, plus a 6 month booster.

Intervention Type BEHAVIORAL

Teens in the control group will receive generic, web-based asthma education.

Web-based, generic asthma management intervention delivered in 4 sessions.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

13 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No