Use of research electronic data capture (REDCap) in a COVID-19 randomized controlled trial: a practical example

Sina Kianersi, Maya Luetke, Christina Ludema, Alexander Valenzuela, Molly Rosenberg, Sina Kianersi, Maya Luetke, Christina Ludema, Alexander Valenzuela, Molly Rosenberg

Abstract

Background: Randomized controlled trials (RCT) are considered the ideal design for evaluating the efficacy of interventions. However, conducting a successful RCT has technological and logistical challenges. Defects in randomization processes (e.g., allocation sequence concealment) and flawed masking could bias an RCT's findings. Moreover, investigators need to address other logistics common to all study designs, such as study invitations, eligibility screening, consenting procedure, and data confidentiality protocols. Research Electronic Data Capture (REDCap) is a secure, browser-based web application widely used by researchers for survey data collection. REDCap offers unique features that can be used to conduct rigorous RCTs.

Methods: In September and November 2020, we conducted a parallel group RCT among Indiana University Bloomington (IUB) undergraduate students to understand if receiving the results of a SARS-CoV-2 antibody test changed the students' self-reported protective behavior against coronavirus disease 2019 (COVID-19). In the current report, we discuss how we used REDCap to conduct the different components of this RCT. We further share our REDCap project XML file and instructional videos that investigators can use when designing and conducting their RCTs.

Results: We reported on the different features that REDCap offers to complete various parts of a large RCT, including sending study invitations and recruitment, eligibility screening, consenting procedures, lab visit appointment and reminders, data collection and confidentiality, randomization, blinding of treatment arm assignment, returning test results, and follow-up surveys.

Conclusions: REDCap offers powerful tools for longitudinal data collection and conduct of rigorous and successful RCTs. Investigators can make use of this electronic data capturing system to successfully complete their RCTs.

Trial registration: The RCT was prospectively (before completing data collection) registered at ClinicalTrials.gov; registration number: NCT04620798 , date of registration: November 9, 2020.

Keywords: RCT; REDCap; Randomization; Randomized controlled trials; Risk of bias.

Conflict of interest statement

Alexander Valenzuela is affiliated with REDCap. Other authors declare that they have no competing interests.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Type and number of emails sent to the study sample, identified by Survey Distribution Tools on REDCap
Fig. 2
Fig. 2
Time and number of study invitation emails sent with REDCap Survey Distribution Tools. Panel A. Cumulative number of responses to study invitation emails. Panel B. Number of responses to study invitation emails. * We resent the first study invitation to a portion of our initial sample because a subject line was omitted from the original email

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