Asthma
Conditions
Keywords
Urban adolescents, Acute asthma, Asthma, Computer tailoring, Web-based intervention, Puff City
Brief summary
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.
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.
Interventions
BEHAVIORALTeens 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.
BEHAVIORALTeens in the control group will receive generic, web-based asthma education.
Web-based, generic asthma management intervention delivered in 4 sessions.
Sponsors
University of Michigan
Augusta University
National Heart, Lung, and Blood Institute (NHLBI)
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 19 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Control Test (ACT) | 12 Months | Comparison of ACT scores at 12 months after the randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Asthma Exacerbations/Functional Status | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The Cost | 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 | Up to 12 months | The cost effectiveness of Puff City intervention compared to controls without study intervention. |
Countries
United States
Outcome results
None listed