Feasibility Study of Preoperative Cognitive Training in Cardiac Surgical Patients (Cog-Train)

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

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Cognitive Dysfunction
• Intervention / Treatment: Behavioral: Cog-Train Intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB23 3RE
      • Papworth Hospital NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Cog-Train Intervention

Behavioral: Cog-Train Intervention; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Papworth Hospital NHS Foundation Trust
• Collaborators: Medical Research Council Cognition and Brain Sciences Unit
• Investigators: Principal Investigator: Alain Vuylsteke, MD, Papworth Hospital NHS Foundation Trust

Publications and helpful links

General Publications

• Schweizer S, Hampshire A, Dalgleish T. Extending brain-training to the affective domain: increasing cognitive and affective executive control through emotional working memory training. PLoS One. 2011;6(9):e24372. doi: 10.1371/journal.pone.0024372. Epub 2011 Sep 19.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2018
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: January 20, 2014
• First Submitted That Met QC Criteria: January 31, 2014
• First Posted (Estimate): February 3, 2014

Study Record Updates

• Last Update Posted (Actual): December 2, 2017
• Last Update Submitted That Met QC Criteria: November 29, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Cognitive function; Preoperative; Cardiac surgery; Cognitive training; Brain training; Plasticity-based training
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Postoperative Complications; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Postoperative Cognitive Complications
• Other Study ID Numbers: P01907

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No