Web-Based and Tailored Asthma Management Intervention (Puff City) in Teens With Asthma Attending Urban Clinics

Asthma Clinical Trial

— PCC  

Official title:

Pragmatic Randomized Controlled Trial of the Web-Based Asthma Management Intervention (Puff City) in Teens With Asthma Attending Urban Clinics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01757002
• Other study ID #: 1R01HL114981-01
• Secondary ID: 1R01HL114981-01
• Status: Completed
• Phase: N/A
• First received: December 7, 2012
• Last updated: August 8, 2017
• Start date: March 2013
• Est. completion date: November 2016

Study information

• Verified date: August 2017
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: November 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

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.
• Teens in the control group will receive generic, web-based asthma education.
Web-based, generic asthma management intervention delivered in 4 sessions.

Locations

Country	Name	City	State
United States	Henry Ford Health System	Detroit	Michigan

Sponsors (4)

Lead Sponsor	Collaborator
Henry Ford Health System	Augusta University, National Heart, Lung, and Blood Institute (NHLBI), University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	The Cost Effectiveness	The cost effectiveness of Puff City intervention compared to controls without study intervention.	Up to 12 months
Primary	Asthma Control Test (ACT)	Comparison of ACT scores at 12 months after the randomization	12 Months
Secondary	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