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Completed

NCT Number: NCT01757002

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

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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Key information

Age range

13 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henry Ford Health System

Detroit, Michigan, 48202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Behavioral

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

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

Behavioral

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

Primary outcomes

  1. Asthma Control Test (ACT)

    Time frame: 12 Months

    Comparison of ACT scores at 12 months after the randomization

Secondary outcomes

  1. Asthma Exacerbations/Functional Status

    Time frame: 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.

Other outcomes

  1. The Cost

    Time frame: Up to 12 months

    The cost of study intervention will be evaluated: The cost for participant enrollment with Electronic Medical Record (EMR) initiation; data collection and management with/o EMR initiation including assessing the reliability of EMR clinical outcomes/primary endpoints, compared to chart abstraction.

  2. The Cost Effectiveness

    Time frame: Up to 12 months

    The cost effectiveness of Puff City intervention compared to controls without study intervention.

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Collaborators

  • Augusta University
  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of Michigan

Registry information

Official study title

Pragmatic Randomized Controlled Trial of the Web-Based Asthma Management Intervention (Puff City) in Teens With Asthma Attending Urban Clinics

Acronym: PCC

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Dec 28, 2012
Registry last updated
Aug 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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