A Web-Based Data Collection Platform for Multisite Randomized Behavioral Intervention Trials: Development, Key Software Features, and Results of a User Survey.

Autor:	Modi RA; University of Alabama at Birmingham, Birmingham, AL, United States., Mugavero MJ; University of Alabama at Birmingham, Birmingham, AL, United States., Amico RK; University of Michigan, Ann Arbor, MI, United States., Keruly J; John Hopkins University, Baltimore, MD, United States., Quinlivan EB; University of North Carolina at Chapel Hill, Chapel Hill, NC, United States., Crane HM; University of Washington, Seattle, WA, United States., Guzman A; University of Alabama at Birmingham, Birmingham, AL, United States., Zinski A; University of Alabama at Birmingham, Birmingham, AL, United States., Montue S; John Hopkins University, Baltimore, MD, United States., Roytburd K; University of North Carolina at Chapel Hill, Chapel Hill, NC, United States., Church A; University of Washington, Seattle, WA, United States., Willig JH; University of Alabama at Birmingham, Birmingham, AL, United States.
Jazyk:	angličtina
Zdroj:	JMIR research protocols [JMIR Res Protoc] 2017 Jun 16; Vol. 6 (6), pp. e115. Date of Electronic Publication: 2017 Jun 16.
DOI:	10.2196/resprot.6768
Abstrakt:	Background: Meticulous tracking of study data must begin early in the study recruitment phase and must account for regulatory compliance, minimize missing data, and provide high information integrity and/or reduction of errors. In behavioral intervention trials, participants typically complete several study procedures at different time points. Among HIV-infected patients, behavioral interventions can favorably affect health outcomes. In order to empower newly diagnosed HIV positive individuals to learn skills to enhance retention in HIV care, we developed the behavioral health intervention Integrating ENGagement and Adherence Goals upon Entry (iENGAGE) funded by the National Institute of Allergy and Infectious Diseases (NIAID), where we deployed an in-clinic behavioral health intervention in 4 urban HIV outpatient clinics in the United States. To scale our intervention strategy homogenously across sites, we developed software that would function as a behavioral sciences research platform. Objective: This manuscript aimed to: (1) describe the design and implementation of a Web-based software application to facilitate deployment of a multisite behavioral science intervention; and (2) report on results of a survey to capture end-user perspectives of the impact of this platform on the conduct of a behavioral intervention trial. Methods: In order to support the implementation of the NIAID-funded trial iENGAGE, we developed software to deploy a 4-site behavioral intervention for new clinic patients with HIV/AIDS. We integrated the study coordinator into the informatics team to participate in the software development process. Here, we report the key software features and the results of the 25-item survey to evaluate user perspectives on research and intervention activities specific to the iENGAGE trial (N=13). Results: The key features addressed are study enrollment, participant randomization, real-time data collection, facilitation of longitudinal workflow, reporting, and reusability. We found 100% user agreement (13/13) that participation in the database design and/or testing phase made it easier to understand user roles and responsibilities and recommended participation of research teams in developing databases for future studies. Users acknowledged ease of use, color flags, longitudinal work flow, and data storage in one location as the most useful features of the software platform and issues related to saving participant forms, security restrictions, and worklist layout as least useful features. Conclusions: The successful development of the iENGAGE behavioral science research platform validated an approach of early and continuous involvement of the study team in design development. In addition, we recommend post-hoc collection of data from users as this led to important insights on how to enhance future software and inform standard clinical practices. Trial Registration: Clinicaltrials.gov NCT01900236; (https://clinicaltrials.gov/ct2/show/NCT01900236 (Archived by WebCite at http://www.webcitation.org/6qAa8ld7v). (©Riddhi A Modi, Michael J Mugavero, Rivet K Amico, Jeanne Keruly, Evelyn Byrd Quinlivan, Heidi M Crane, Alfredo Guzman, Anne Zinski, Solange Montue, Katya Roytburd, Anna Church, James H Willig. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 16.06.2017.)
Databáze:	MEDLINE
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