Henry Ford Health System
Detroit, Michigan, 48202, United States
NCT Number: NCT01757002
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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Notify Me13 year–19 year
All sexes
Interventional
Not applicable
Detroit, Michigan, 48202, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Web-based, computer-tailored asthma management intervention delivered in 4 sessions, plus a 6 month booster.
Web-based, generic asthma management intervention delivered in 4 sessions.
Time frame: 12 Months
Comparison of ACT scores at 12 months after the randomization
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.
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.
Time frame: Up to 12 months
The cost effectiveness of Puff City intervention compared to controls without study intervention.
Henry Ford Health System
Other
Pragmatic Randomized Controlled Trial of the Web-Based Asthma Management Intervention (Puff City) in Teens With Asthma Attending Urban Clinics
Acronym: PCC
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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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