Viewing Study NCT01757002


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Study NCT ID: NCT01757002
Status: COMPLETED
Last Update Posted: 2017-08-09
First Post: 2012-12-07
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Web-Based and Tailored Asthma Management Intervention (Puff City) in Teens With Asthma Attending Urban Clinics
Sponsor: Henry Ford Health System
Organization:

Study Overview

Official Title: Pragmatic Randomized Controlled Trial of the Web-Based Asthma Management Intervention (Puff City) in Teens With Asthma Attending Urban Clinics
Status: COMPLETED
Status Verified Date: 2017-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: PCC
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.

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?:

Secondary ID Infos

Secondary ID Type Domain Link View
1R01HL114981-01 NIH None https://reporter.nih.gov/quic… View