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

This study is currently recruiting participants.
Verified October 2012 by Henry Ford Health System
Sponsor:
Collaborators:
University of Michigan
Georgia Regents University
Kaiser Permanente
Information provided by (Responsible Party):
Dr. Mei Lu, Henry Ford Health System
ClinicalTrials.gov Identifier:
NCT01757002
First received: December 7, 2012
Last updated: April 15, 2013
Last verified: October 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Pragmatic Randomized Controlled Trial of the Web-Based Asthma Management Intervention (Puff City) in Teens With Asthma Attending Urban Clinics

Resource links provided by NLM:


Further study details as provided by Henry Ford Health System:

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


Secondary Outcome Measures:
  • Asthma Exacerbations/Functional Status [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The cost effectiveness of Puff City intervention compared to controls without study intervention.


Estimated Enrollment: 354
Study Start Date: March 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: March 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

Ages Eligible for Study:   13 Years to 19 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01757002

Contacts
Contact: Christina M Melkonian, BS, CCRA 313-874-6854 cmelkon1@hfhs.org
Contact: Dayna Johnson, MPH 313-874-2888 djohnso1@hfhs.org

Locations
United States, Georgia
Kaiser Permanente Not yet recruiting
Atlanta, Georgia, United States, 30305
Contact: , PhD         
Principal Investigator: Douglas Roblin, PhD         
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Christina Melkonian, BS    313-874-6854    CMELKON1@hfhs.org   
Contact: Dayna Johnson, MS    313-874-2888    DJOHNSO3@hfhs.org   
Principal Investigator: Mei Lu, PhD         
Principal Investigator: Christine Joseph, PhD         
Sponsors and Collaborators
Henry Ford Health System
University of Michigan
Georgia Regents University
Kaiser Permanente
Investigators
Principal Investigator: Mei Lu, PhD Henry Ford Health System
Principal Investigator: Christine Joseph, PhD Henry Ford Health System
  More Information

No publications provided

Responsible Party: Dr. Mei Lu, Senior Biostatistician, Henry Ford Health System
ClinicalTrials.gov Identifier: NCT01757002     History of Changes
Other Study ID Numbers: 1R01 HL114981-01, 1R01HL114981-01
Study First Received: December 7, 2012
Last Updated: April 15, 2013
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by 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

ClinicalTrials.gov processed this record on April 15, 2014