Phase II trial of web-based tailored asthma management intervention in adolescents at clinics

• Type of Material: Article
• Authors: Mei Lu, Henry Ford Hospital; Talan Zhang, Henry Ford Hospital; Dennis R. Ownby, Augusta University; Edward Zoratti, Henry Ford Hospital; Dayna Johnson, Emory University; Renee William, Henry Ford Hospital; Cheryl Miree, Henry Ford Hospital; Christine L. M. Joseph, Henry Ford Hospital
• Language: English
• Date: 2019-07-01
• Publisher: Elsevier Science Inc.
• Publication Version: Author Accepted Manuscript (After Peer Review)
• Copyright Statement: © 2019 Elsevier Inc. All rights reserved.
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1016/j.cct.2019.04.011
• Title of Journal or Parent Work: Contemporary Clinical Trials
• Volume: 82
• Start Page: 46
• End Page: 52
• Grant/Funding Information: This work was supported by the National Institutes of Health [grant number R01HL114981–02]
• Keywords: Life Sciences & Biomedicine; Research & Experimental Medicine; Medicine, Research & Experimental; Program; Science & Technology; Pharmacology & Pharmacy
• Research Categories: Health Sciences, Pharmacology; Health Sciences, Public Health; Health Sciences, Epidemiology

Abstract

Clinical trials are critical for medical decision-making; however, conduct is costly and labor intensive. Traditionally, clinical trials are conducted in a controlled environment with a restricted patient population. In addition to the use of electronic initiatives (e-initiatives) such as the use of electronic medical records (EMR) for patient identification, recruitment and data collection, pragmatic clinical trials promote patient enrollment in a “real world” setting with fewer exclusion criteria and less need for research infrastructure. The pragmatic trial also uses comparative adaptive methods and approaches to ensure results provide real-world evidence, i.e., evidence that study execution and data analysis are translatable to practice. Puff City, a web-based, asthma management program for urban adolescents with asthma, has been evaluated in Detroit Public High Schools [1] [2], and results of these school-based randomized trials were promising for potential dissemination beyond schools [1] [2]. To demonstrate pragmatic approaches to conduct of a randomized trial, we extended the Puff City program to a clinical setting and conducted a seamless Phase II/III pragmatic trial of the program in a group of urban, primary care clinics.