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Use of research electronic data capture (REDCap) in a COVID-19 randomized controlled trial: a practical example
Sina Kianersi1, Maya Luetke2, Christina Ludema2
1Department of Epidemiology and Biostatistics, Indiana University School of Public Health-Bloomington, Bloomington, IN, USA. skianers@iu.edu.
BMC Medical Research Methodology
|August 22, 2021
Summary
This study demonstrates how Research Electronic Data Capture (REDCap) can streamline randomized controlled trials (RCTs). REDCap facilitates key RCT components, enhancing data integrity and logistical management for researchers conducting clinical studies.
Area of Science:
- Clinical Trials Methodology
- Health Informatics
- Epidemiology
Background:
- Randomized controlled trials (RCTs) are the gold standard for intervention efficacy but face logistical and technological hurdles.
- Potential biases in RCTs stem from flawed randomization and masking procedures.
- Efficient management of study invitations, screening, consent, and data confidentiality is crucial for all study designs.
Purpose of the Study:
- To illustrate the application of Research Electronic Data Capture (REDCap) in conducting a rigorous randomized controlled trial (RCT).
- To detail the utilization of REDCap's features for managing various RCT components.
- To provide resources (XML file, instructional videos) for researchers designing and executing their own RCTs using REDCap.
Main Methods:
- A parallel-group randomized controlled trial (RCT) was conducted among undergraduate students at Indiana University Bloomington in September and November 2020.
- The study investigated the impact of receiving SARS-CoV-2 antibody test results on self-reported protective behaviors against COVID-19.
- REDCap was employed to manage all facets of the RCT, from recruitment to data collection and follow-up.
Main Results:
- REDCap facilitated numerous aspects of the RCT, including participant recruitment, eligibility screening, and informed consent processes.
- The platform managed lab visit scheduling, appointment reminders, data collection, and ensured data confidentiality.
- REDCap was instrumental in randomization, blinding of treatment assignments, result delivery, and conducting follow-up surveys.
Conclusions:
- Research Electronic Data Capture (REDCap) provides robust tools for longitudinal data collection and the execution of rigorous, successful RCTs.
- Investigators can leverage REDCap's capabilities to efficiently manage and complete complex clinical trials.
- The study offers practical insights and shareable resources for implementing REDCap in RCT settings.
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