Mobile Device-Based Electronic Data Capture System Used in a Clinical Randomized Controlled Trial: Advantages and...

Area of Science:

• Clinical Research
• Health Informatics
• Hypertension Management

Background:

• Electronic data capture (EDC) systems are standard in clinical research.
• Mobile electronic data capture (mEDC) systems require further evaluation for their utility.
• Assessing mEDC feasibility, advantages, and challenges is crucial for advancing clinical trial methodologies.

Purpose of the Study:

• To evaluate the feasibility, advantages, and challenges of implementing a mobile electronic data capture (mEDC) system.
• To assess mEDC's role in data collection, project management, and telemonitoring within a randomized controlled trial (RCT).
• To determine user acceptance and identify potential implementation barriers for mEDC in clinical research.

Main Methods:

• Development and implementation of a custom mEDC system for the "Telmisartan and Hydrochlorothiazide Antihypertensive Treatment (THAT)" study, a multicenter, double-blinded RCT.
• Utilizing semistructured interviews with participants (doctors, patients) and study staff (CRA, PM, DM) to gather qualitative data on mEDC experience.
• Employing NVivo software and a thematic framework method for analyzing interview data to identify key outcomes related to feasibility, advantages, and challenges.

Main Results:

• The mEDC system was successfully deployed across 14 hospitals, supporting the recruitment of 1333 patients in the THAT study.
• Average data collection time per patient was 53 minutes, deemed acceptable by both clinicians and participants.
• High user satisfaction (average score 9.2/10) was reported for mEDC functions including randomization, data collection, project management, and real-time remote monitoring.

Conclusions:

• The developed mEDC system is a feasible and well-accepted tool for clinical trials.
• mEDC significantly enhances the efficiency of data collection and project management in clinical research.
• The study highlights the potential of mEDC to streamline trial operations and improve user experience, despite potential signal stability challenges.