Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL114981-01 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Michigan | OTHER |
| Augusta University | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tailored asthma management program | Experimental | Teens randomized to the experimental arm will receive 4 sessions plus a booster of web-based, tailored asthma management. |
|
| Control | Active Comparator | Teens in the control group will receive generic, web-based asthma education. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teens randomized to the experimental arm will receive 4 sessions plus a booster of web-based, tailored asthma management. | Behavioral | Web-based, computer-tailored asthma management intervention delivered in 4 sessions, plus a 6 month booster. |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma Control Test (ACT) | Comparison of ACT scores at 12 months after the randomization | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma Exacerbations/Functional Status | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The Cost | 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 |
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:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mei Lu, PhD | Henry Ford Health System | Principal Investigator |
| Christine Joseph, PhD | Henry Ford Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24607295 | Derived | Lu M, Ownby DR, Zoratti E, Roblin D, Johnson D, Johnson CC, Joseph CL. Improving efficiency and reducing costs: Design of an adaptive, seamless, and enriched pragmatic efficacy trial of an online asthma management program. Contemp Clin Trials. 2014 May;38(1):19-27. doi: 10.1016/j.cct.2014.02.008. Epub 2014 Mar 6. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Teens in the control group will receive generic, web-based asthma education. | Behavioral | Web-based, generic asthma management intervention delivered in 4 sessions. |
|
| The Cost Effectiveness |
The cost effectiveness of Puff City intervention compared to controls without study intervention. |
| Up to 12 months |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided