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

摘要

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 guide- line on how to implement ambulatory assessment using REDCap and provide preliminary evi- dence of feasibility.Methods: Feasibility and acceptability data are presented for randomized participants (Nranged 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 assess- ments were easy to use, and 78.9% of participants preferred the REDCap assessments to tradi- tional, 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.