- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01757002
Web-Based and Tailored Asthma Management Intervention (Puff City) in Teens With Asthma Attending Urban Clinics (PCC)
Pragmatic Randomized Controlled Trial of the Web-Based Asthma Management Intervention (Puff City) in Teens With Asthma Attending Urban Clinics
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Health System
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tailored asthma management program
Teens randomized to the experimental arm will receive 4 sessions plus a booster of web-based, tailored asthma management.
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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.
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Web-based, generic asthma management intervention delivered in 4 sessions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Asthma Control Test (ACT)
Time Frame: 12 Months
|
Comparison of ACT scores at 12 months after the randomization
|
12 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 Months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 12 months
|
The Cost Effectiveness
Time Frame: Up to 12 months
|
The cost effectiveness of Puff City intervention compared to controls without study intervention.
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Up to 12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christine Joseph, PhD, Henry Ford Health System
- Principal Investigator: Mei Lu, PhD, Henry Ford Health System
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R01HL114981-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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