Integrating technology into complex intervention trial processes: a case study.

Area of Science:

• Clinical Trials Methodology
• Health Informatics
• Rehabilitation Science

Background:

• Complex intervention trials face high costs and logistical challenges, including data collection and fidelity assessment across multiple sites.
• Traditional paper-based data collection is inefficient and prone to errors.
• Electronic data collection offers potential solutions but is underutilized in complex intervention trials.

Purpose of the Study:

• To present the implementation and impact of a custom-built online system for managing data and monitoring processes in a multicenter complex intervention trial.
• To evaluate the system's efficiency, data quality, and user acceptability.

Main Methods:

• A web-accessible software application was custom-built for the ENGAGE-HD trial, a multicenter physical therapy intervention.
• The system integrated participant randomization, data collection, and intervention fidelity assessment.
• Sites used 4G-enabled iPads for system access, with tiered user permissions.

Main Results:

• The system achieved a 98.5% data completion rate and a 0.1% data query rate, with most queries resolved within a week.
• Research staff feedback indicated high acceptability due to portability, accessibility (via iPad), and effectiveness in aiding data collection and administration.
• The system proved to be an efficient tool for managing trial processes and monitoring intervention fidelity.

Conclusions:

• A combination of commercial hardware and a bespoke online database offers a viable solution for streamlining multicenter complex intervention trials.
• The system effectively supports data collection, intervention fidelity, and trial progress monitoring.
• Future enhancements could include automatic reporting and participant management for larger trials.