Web-Based and Tailored Asthma Management Intervention (Puff City) in Teens With Asthma Attending Urban Clinics (PCC)
Recruitment status was: Recruiting
|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 Design:||Allocation: Randomized
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|
- 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.
|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)|
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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01757002
|Contact: Christina M Melkonian, MSfirstname.lastname@example.org|
|Contact: Renee Bourgeois-Williams, MS||313-874-3995||RBOURGE1@hfhs.org|
|United States, Michigan|
|Henry Ford Health System||Recruiting|
|Detroit, Michigan, United States, 48202|
|Contact: Christina Melkonian, MS 313-874-6854 CMELKON1@hfhs.org|
|Contact: Renee Bourgeois-Williams, MS 313-874-3995 RBOURGE1@hfhs.org|
|Principal Investigator: Mei Lu, PhD|
|Principal Investigator: Christine Joseph, PhD|
|Principal Investigator:||Mei Lu, PhD||Henry Ford Health System|
|Principal Investigator:||Christine Joseph, PhD||Henry Ford Health System|