Development and Use of a Tech-Based Data Management System for a Cognitive Rehabilitation Randomized Controlled Trial...

Area of Science:

• Health Informatics
• Digital Health
• Clinical Research Informatics

Background:

• Technology-based interventions show promise for enhancing patient self-management.
• A gap exists in guidance for developing such interventions.
• Previous research highlights the need for structured approaches to technology implementation in clinical trials.

Purpose of the Study:

• To describe the electronic process of designing and implementing a technology-based data management system.
• To provide a framework for developing technology-based interventions for clinical trials.
• To improve cognitive function and diabetes self-management in individuals with type 2 diabetes.

Main Methods:

• Feasibility assessment and interdisciplinary collaboration were key components of system development.
• Design mapping and utilization of institutional/commercial software informed the process.
• A randomized controlled trial methodology was employed for intervention evaluation.

Main Results:

• A comprehensive technology-based data management system was successfully designed and implemented.
• The developed framework serves as a template for future technology-based intervention creation.
• The system facilitated a randomized controlled trial for cognitive rehabilitation in type 2 diabetes.

Conclusions:

• The developed framework supports the creation of technology-based interventions.
• Despite initial time investment, technology-based approaches offer significant benefits.
• This systematic approach can guide researchers in implementing digital health solutions.