Web-Based and Tailored Asthma Management Intervention (Puff City) in Teens With Asthma Attending Urban Clinics (PCC)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
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 Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study 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 ] [ Designated as safety issue: Yes ]Comparison of ACT scores at 12 months after the randomization
- Asthma Exacerbations/Functional Status [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]The cost effectiveness of Puff City intervention compared to controls without study intervention.
| Estimated Enrollment: | 354 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 13 Years to 19 Years |
| Genders Eligible for Study: | Both |
| Accepts 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.
Contacts and Locations| Contact: Christina M Melkonian, BS, CCRA | 313-874-6854 | cmelkon1@hfhs.org |
| Contact: Dayna Johnson, MPH | 313-874-2888 | djohnso1@hfhs.org |
| United States, Georgia | |
| Kaiser Permanente | Not yet recruiting |
| Atlanta, Georgia, United States, 30305 | |
| Contact: , PhD | |
| Principal Investigator: Douglas Roblin, PhD | |
| United States, Michigan | |
| Henry Ford Health System | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| Contact: Christina Melkonian, BS 313-874-6854 CMELKON1@hfhs.org | |
| Contact: Dayna Johnson, MS 313-874-2888 DJOHNSO3@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 |
More Information
No publications provided
| Responsible Party: | Dr. Mei Lu, Senior Biostatistician, Henry Ford Health System |
| ClinicalTrials.gov Identifier: | NCT01757002 History of Changes |
| Other Study ID Numbers: | 1R01 HL114981-01, 1R01HL114981-01 |
| Study First Received: | December 7, 2012 |
| Last Updated: | April 15, 2013 |
| Health Authority: | United States: Data and Safety Monitoring Board |
Keywords provided by Henry Ford Health System:
|
Urban adolescents Acute asthma Asthma |
Computer tailoring Web-based intervention Puff City |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013