A new clinical trial is investigating the efficacy of an innovative computerized cognitive training program designed specifically for patients with coronary heart disease, potentially offering a novel therapeutic approach for maintaining cognitive function in this high-risk population.
The cloud-based digital intervention, developed by leading researchers, incorporates adaptive algorithms and classic psychological paradigms such as the Stroop Effect and Dual-Task Paradigm. The system uniquely adjusts training difficulty based on patient performance across multiple cognitive domains.
Study Design and Implementation
The trial has enrolled 200 patients, stratified by age and education level, randomly assigned to either the cognitive digital therapy group or a positive control group. The intervention protocol requires participants to complete 30-minute training sessions five days per week, with the experimental group receiving multitask adaptive training covering sensory perception, attention, memory, thinking, and processing speed.
The control group undergoes fixed-difficulty cognitive exercises, ensuring comparable training duration but without the adaptive elements. This design allows researchers to isolate the impact of the adaptive, multi-domain training approach.
Comprehensive Assessment Protocol
The study's primary endpoint measures improvement in overall cognitive function at 12 weeks using the validated BCAT (Basic Cognitive Ability Tests) software, which evaluates four key domains:
- Processing speed through symbol search tasks
- Working memory via operation span tests
- Episodic memory using portrait memory exercises
- Visuospatial intelligence through paper-folding tests
Advanced Monitoring and Support Systems
The platform features sophisticated compliance monitoring tools, allowing researchers to track patient engagement and training completion in real-time. The system includes:
- Visual management of training status
- Automated follow-up reminders
- Daily training duration tracking
- Performance scoring metrics
To ensure consistent participation, the trial implements multiple support mechanisms, including medical staff assistance, family member training, and incentive measures such as extended software access post-study.
Secondary Outcomes and Exploratory Measures
Beyond cognitive function, the trial examines several secondary endpoints:
- Quality of life measures using the EQ-5D-3L questionnaire
- Anxiety and depression scores via PHQ-9 and GAD-7 assessments
- Self-efficacy evaluation using the General Self-Efficacy Scale
- Structural and functional brain changes through detailed MRI imaging
Clinical Management and Patient Care
The study emphasizes optimal management of cardiovascular conditions throughout the trial period. Participants receive comprehensive care including:
- Blood pressure management targeting below 140/90 mmHg
- Lipid control based on cardiovascular risk stratification
- Diabetes management aiming for HbA1c below 7%
- Lifestyle modification guidance covering diet, exercise, and smoking cessation
This innovative trial represents a significant step forward in addressing cognitive health in cardiac patients, potentially establishing a new standard for cognitive maintenance in this vulnerable population.
