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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01757002
First Posted: December 28, 2012
Last Update Posted: August 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Michigan
Augusta University
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Dr. Mei Lu, Henry Ford Health System
  Purpose
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.

Condition Intervention
Asthma 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.

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pragmatic Randomized Controlled Trial of the Web-Based Asthma Management Intervention (Puff City) in Teens With Asthma Attending Urban Clinics

Further study details as provided by Dr. Mei Lu, Henry Ford Health System:

Primary Outcome Measures:
  • Asthma Control Test (ACT) [ Time Frame: 12 Months ]
    Comparison of ACT scores at 12 months after the randomization


Secondary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • The Cost Effectiveness [ Time Frame: Up to 12 months ]
    The cost effectiveness of Puff City intervention compared to controls without study intervention.


Enrollment: 266
Study Start Date: March 2013
Study Completion Date: November 2016
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tailored asthma management program
Teens randomized to the experimental arm will receive 4 sessions plus a booster of web-based, tailored asthma management.
Behavioral: 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.
Active Comparator: Control
Teens in the control group will receive generic, web-based asthma education.
Behavioral: Teens in the control group will receive generic, web-based asthma education.
Web-based, generic asthma management intervention delivered in 4 sessions.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01757002


Locations
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
Sponsors and Collaborators
Henry Ford Health System
University of Michigan
Augusta University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Mei Lu, PhD Henry Ford Health System
Principal Investigator: Christine Joseph, PhD Henry Ford Health System
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Mei Lu, Senior Biostatistician, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT01757002     History of Changes
Other Study ID Numbers: 1R01HL114981-01 ( U.S. NIH Grant/Contract )
First Submitted: December 7, 2012
First Posted: December 28, 2012
Last Update Posted: August 9, 2017
Last Verified: August 2017

Keywords provided by Dr. Mei Lu, Henry Ford Health System:
Urban adolescents
Acute asthma
Asthma
Computer tailoring
Web-based intervention
Puff City

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases