Work

Evaluation of a remote biomarker capture system integrated with REDCap: A decentralized randomized trial

Year: 2025

Type: article

Study designs: Randomized Controlled Trial, Clinical Trial

Abstract: Introduction: Decentralized clinical trials (DCTs) are often hindered by challenges in remotely capturing biomarkers. To address this gap, we developed MyTrials, a mobile application integrated with REDCap, designed to facilitate the remote capture of biomarkers via Bluetooth-enabled remote patient monitoring (RPM) devices. The purpose of the present study was to evaluate the feasibility and acceptability of MyTrials among participants within a DCT design. Methods: In this four-arm randomized trial, 47 participants were allocated to receive zero, one, two, or three RPM devices. Participants were asked to use their devices once per week for a total of four weeks to remotely provide biomarkers via MyTrials. Feasibility was assessed using objective metrics of successful biomarker submission (i.e., valid device data accompanied by a video confirming participant identity) alongside the participant-reported Feasibility of Intervention Measure (FIM). Acceptability was evaluated via the Acceptability of Intervention Measure (AIM) and the System Usability Scale (SUS). Results: Among participants assigned at least one device, the successful biomarker submission rate was 74% across all study weeks. FIM and AIM scores exceeded prespecified feasibility benchmarks across all conditions except the zero-device condition. SUS scores consistently indicated high usability across all conditions (range: 77.29-94.29). Conclusions: The MyTrials platform is a feasible and acceptable solution for remote biomarker capture in DCTs. These findings support the potential of MyTrials to advance remote data collection in clinical research.

Source: Journal of Clinical and Translational Science

DOI: 10.1017/cts.2025.10160

Authors: Jennifer Dahne, Amy E. Wahlquist, Jacob Kustanowitz, Juliana Hayden, Noelle Natale, John Clark

Institutions: University of Vienna, Medical University of South Carolina, MUSC Hollings Cancer Center, East Tennessee State University

Language: English

Topic: Mobile Health and mHealth Applications

Subfield: General Health Professions

Field: Health Professions

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $3,200