search
Back to results

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

Primary Purpose

Postoperative Cognitive Dysfunction

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Cog-Train Intervention
Sponsored by
Papworth Hospital NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Postoperative Cognitive Dysfunction focused on measuring Cognitive training, Brain training, Plasticity-based training, Cardiac surgery, Preoperative, Cognitive function

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Papworth Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cog-Train Intervention

Arm Description

Outcomes

Primary Outcome Measures

Training performance gain
Average increase in training task level achieved from first to last training day
Adherence to training regimen
Mean number of training days completed according to instructions

Secondary Outcome Measures

Recruitment and retention
Proportion of patients approached who can do the task and are willing to take part
Satisfaction and acceptability
Self report questionnaire
Side-effects
Side effects and severity reported by patients and proportion of patients who reported side-effects

Full Information

First Posted
January 20, 2014
Last Updated
November 29, 2017
Sponsor
Papworth Hospital NHS Foundation Trust
Collaborators
Medical Research Council Cognition and Brain Sciences Unit
search

1. Study Identification

Unique Protocol Identification Number
NCT02053207
Brief Title
Feasibility Study of Preoperative Cognitive Training in Cardiac Surgical Patients
Acronym
Cog-Train
Official Title
The Cog-Train Feasibility Study: a Single-arm Trial Investigating the Feasibility of a Preoperative Cognitive Training Intervention (Cog-Train) in Cardiac Surgical Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2018 (Anticipated)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Papworth Hospital NHS Foundation Trust
Collaborators
Medical Research Council Cognition and Brain Sciences Unit

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Cognitive Dysfunction
Keywords
Cognitive training, Brain training, Plasticity-based training, Cardiac surgery, Preoperative, Cognitive function

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cog-Train Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Cog-Train Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Training performance gain
Description
Average increase in training task level achieved from first to last training day
Time Frame
From 21 days prior to scheduled surgery to 1 day prior to scheduled surgery
Title
Adherence to training regimen
Description
Mean number of training days completed according to instructions
Time Frame
From 21 days prior to scheduled surgery to 1 day prior to scheduled surgery
Secondary Outcome Measure Information:
Title
Recruitment and retention
Description
Proportion of patients approached who can do the task and are willing to take part
Time Frame
10 weeks
Title
Satisfaction and acceptability
Description
Self report questionnaire
Time Frame
At 1 day prior to scheduled surgery
Title
Side-effects
Description
Side effects and severity reported by patients and proportion of patients who reported side-effects
Time Frame
From 21 days prior to scheduled surgery to up to 14 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kimberly Giraud, PhD
Phone
01480 830541
Email
kimberly.giraud@papworth.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain Vuylsteke, MD
Organizational Affiliation
Papworth Hospital NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Papworth Hospital NHS Foundation Trust
City
Cambridge
State/Province
Cambridgeshire
ZIP/Postal Code
CB23 3RE
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21949712
Citation
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.
Results Reference
background

Learn more about this trial

Feasibility Study of Preoperative Cognitive Training in Cardiac Surgical Patients

We'll reach out to this number within 24 hrs