Feasibility Study of Preoperative Cognitive Training in Cardiac Surgical Patients

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the feasibility of administering a 20-day preoperative cognitive training intervention (Cog-Train) to a widely inclusive sample of cardiac surgical patients.

Detailed Description
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Cognitive outcomes remain poor after cardiac surgery. Data from the field of cognitive neuroscience suggests that cognitive training, which harnesses the brain's adaptive plasticity to improve, maintain, or restore function in a target area, can be used to strengthen brain resilience and improve cognitive outcomes following challenge. While its effectiveness has been demonstrated in older adults as well as in other (nonsurgical) patient populations, no training intervention like this has ever before been used in any surgical patient in the preoperative period. The purpose of this study is to evaluate the feasibility of administering a 20-day cognitive training intervention (Cog-Train) to a widely inclusive sample of cardiac surgical patients before their surgery. Data obtained will be used to design a full-scale randomised controlled trial (RCT) on Cog-Train's effectiveness in improving postoperative cognitive outcomes.

Official Title
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The Cog-Train Feasibility Study: a Single-arm Trial Investigating the Feasibility of a Preoperative Cognitive Training Intervention (Cog-Train) in Cardiac Surgical Patients

Conditions
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Postoperative Cognitive Dysfunction

Intervention / Treatment
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* Behavioral: Cog-Train Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled for elective cardiac surgery with cardiopulmonary bypass at Papworth Hospital Aged 60+ years Exclusion Criteria: Surgery scheduled for sooner than 21 days 'Off-pump' surgery being considered Inability to obtain informed consent Sensory or motor impairments impeding use of task Communication barriers impeding administration of study procedures Inability to demonstrate understanding of task and/or study procedures Inability to make time commitment

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cog-Train Intervention<br> | Behavioral: Cog-Train Intervention<br>* Twenty-one days prior to surgery, patients will begin self-administering the intervention using an iPad tablet. This intervention will consist with daily sessions of at least 20 minutes of the Cog-Train task (the task and regimen used to obtain robust effects in previous studies by members of our group). Cog-Train is an n-back task - an adaptive working memory computer game that extends players' working memory capacity by getting progressively more difficult as the player's performance increases.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Training performance gain | Average increase in training task level achieved from first to last training day | From 21 days prior to scheduled surgery to 1 day prior to scheduled surgery | 
| Adherence to training regimen | Mean number of training days completed according to instructions | From 21 days prior to scheduled surgery to 1 day prior to scheduled surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment and retention | Proportion of patients approached who can do the task and are willing to take part | 10 weeks | 
| Satisfaction and acceptability | Self report questionnaire | At 1 day prior to scheduled surgery | 
| Side-effects | Side effects and severity reported by patients and proportion of patients who reported side-effects | From 21 days prior to scheduled surgery to up to 14 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac surgery, Preoperative, Cognitive function, Cognitive training, Brain training, Plasticity-based training