Web-Based and Tailored Asthma Management Intervention (Puff City) in Teens With Asthma Attending Urban Clinics (PCC)
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|ClinicalTrials.gov Identifier: NCT01757002|
Recruitment Status : Completed
First Posted : December 28, 2012
Last Update Posted : August 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|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.||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||266 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pragmatic Randomized Controlled Trial of the Web-Based Asthma Management Intervention (Puff City) in Teens With Asthma Attending Urban Clinics|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||November 2016|
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.
- Asthma Control Test (ACT) [ Time Frame: 12 Months ]Comparison of ACT scores at 12 months after the randomization
- 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.
- 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.
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
|United States, Michigan|
|Henry Ford Health System|
|Detroit, Michigan, United States, 48202|
|Principal Investigator:||Mei Lu, PhD||Henry Ford Health System|
|Principal Investigator:||Christine Joseph, PhD||Henry Ford Health System|