Fully-Online, Interoperable Clinical Trial Management System for Multi-Interventional RCT: Maintain Your Brain...

Area of Science:

• Neuroscience
• Gerontology
• Clinical Informatics

Background:

• Alzheimer's disease and dementia pose significant public health challenges.
• Modifiable risk factors offer targets for prevention strategies.
• Online interventions show promise for large-scale dementia prevention trials.

Purpose of the Study:

• To evaluate the suitability of traditional Clinical Trial Management Systems (CTMS) for the Maintain Your Brain (MYB) randomized controlled trial.
• To identify specific CTMS requirements beyond standard features for complex digital health interventions.
• To inform the development of future CTMS for large-scale, multi-intervention online trials.

Main Methods:

• The Maintain Your Brain (MYB) study utilizes a randomized controlled trial (RCT) design with multiple online interventions.
• Standard CTMS functionalities were assessed against MYB's unique requirements.
• A digital platform architecture was developed to address identified gaps.

Main Results:

• Traditional CTMS inadequately support multiple interventions within a single study.
• Existing systems lack flexible interoperability with third-party software.
• Participant engagement, algorithmic personalization, and long-term data handling present challenges for standard CTMS.

Conclusions:

• Specialized digital platforms are necessary for complex online trials like MYB.
• Future CTMS implementations must incorporate features for multi-intervention support, interoperability, and personalized participant engagement.
• Lessons learned from MYB can guide the development of effective digital trial management solutions for dementia prevention.