Using REDCap for ambulatory assessment: Implementation in a clinical trial for smoking cessation to augment in-person data collection

ABSTRACT

Background: The use of ambulatory assessment to study behavior and physiology in daily life is becoming more common, yet barriers to implementation remain. Limitations in budget, time, and expertise may inhibit development or purchase of dedicated ambulatory assessment software. Research Electronic Data Capture (REDCap) is widely used worldwide, offering a cost-effective and accessible option for implementing research studies. Objectives: To present a step-by-step guideline on how to implement ambulatory assessment using REDCap and provide preliminary evidence of feasibility. Methods: Feasibility and acceptability data are presented for randomized participants (N ranged from 19 to 36, depending on analysis) from an ongoing 8-week smoking cessation pharmacological clinical trial (ClinicalTrials.gov Identifier: NCT02737358). Participants (N = 36; 50% female) completed up to three ambulatory assessment surveys per day, depending on the phase of the study. These included self-report and video confirmation of smoking biomarkers and medication adherence. Results: Participants completed 74.8% of morning reports (86.6% for study completers), 73.8% of videos confirming smoking biomarkers, and 70.4% of videos confirming medication adherence. Study completers reported that the REDCap assessments were easy to use, and 78.9% of participants preferred the REDCap assessments to traditional, paper measures. Conclusions: These data from a pharmacological trial suggest feasibility of remote data collection using REDCap. As REDCap functionality is continually evolving, it is likely that options for collecting ambulatory assessment data via this platform will progressively improve allowing for greater individualization of assessment scheduling for enhancing data collection in clinical trials.

KEYWORDS:

• Ambulatory assessment
• ecological momentary assessment
• REDCap
• medication adherence
• smoking cessation
• clinical trial

Acknowledgments

The authors would like to thank John Clark and Erin Quigley for programming enhanced REDCap features for the purpose of this clinical trial, including survey expiration (prior to REDCap upgrades) and automatic timestamp extraction from video uploads.

Declaration of interest

The authors have no conflicting interests to report.

Notes

¹ For extra security, a participant password for accessing their specific surveys can be created, and this would also be stored as a field on this form (the “Survey Login” feature is optional, but requires that the password be stored in the participant record).

Additional information

Funding

The authors wish to acknowledge funding sources for this manuscript. Funding for this study was provided by NIDA grant R34 DA042228 (McClure), pilot research funding from the Hollings Cancer Center’s Cancer Center Support Grant P30 CA138313 at the Medical University of South Carolina, and pilot research funding from the Department of Psychiatry and Behavioral Sciences at the Medical University of South Carolina. Effort in preparing this work was supported by NIDA grant K01 DA036739 (McClure), NIDA grant R01 DA038700 (Froeliger, Gray, Kalivas), NIDA grant R01 DA042114 (Gray), NIDA Grant UG3 DA043231 (McRae-Clark, Gray), NIDA grant U01 DA031779 (Gray), and NIAAA grant T32 AA007474 (Woodward). Additional funding and support was provided by the South Carolina Clinical and Translational Institute at the Medical University of South Carolina (UL1 TR001450).