Survey Email Scheduling and Monitoring in eRCTs (SESAMe): A Digital Tool to Improve Data Collection in Randomized...

Area of Science:

• Clinical Research Informatics
• Health Services Research
• Medical Informatics

Background:

• Automating electronic data collection in clinical trials is challenging.
• Existing software lacks features for automated participant email distribution at various time points.
• Randomized controlled trials (RCTs) require efficient data management for successful outcomes.

Purpose of the Study:

• To develop automated software for facilitating data collection in a multicenter RCT.
• To address the need for sending numerous emails to participants at different time points.
• To enhance the efficiency of data gathering in the Acuback low back pain study.

Main Methods:

• Developed a Web-based application named Survey Email Scheduling and Monitoring in eRCTs (SESAMe).
• Iterative software development involving study leaders and programmers, with testing and updates.
• Utilized a logbook, research assistant dialogue, and participant queries for evaluation.

Main Results:

• SESAMe successfully scheduled and sent required emails for the Acuback trial.
• The software monitors responses and sends email/SMS reminders to participants.
• Response rates increased from 76.4% to 93.11% after implementing reminders (P<.001).

Conclusions:

• SESAMe software enhances consecutive patient data collection in RCTs.
• The tool can improve response rates and research quality in clinical practice.
• Further development will focus on encryption and data storage security.