Feasibility Study of Preoperative Cognitive Training in Cardiac Surgical Patients

Postoperative Cognitive Dysfunction Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02053207
• Other study ID #: P01907
• Status: Not yet recruiting
• Phase: N/A
• First received: January 20, 2014
• Last updated: November 29, 2017
• Start date: January 2018
• Est. completion date: December 2018

Study information

• Verified date: November 2017
• Source: Papworth Hospital NHS Foundation Trust
• Contact: Kimberly Giraud, PhD
• Phone: 01480 830541
• Email: kimberly.giraud[@]papworth.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Postoperative Cognitive Dysfunction

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.

Locations

Country	Name	City	State
United Kingdom	Papworth Hospital NHS Foundation Trust	Cambridge	Cambridgeshire

Sponsors (2)

Lead Sponsor	Collaborator
Papworth Hospital NHS Foundation Trust	Medical Research Council Cognition and Brain Sciences Unit

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Recruitment and retention	Proportion of patients approached who can do the task and are willing to take part	10 weeks
Secondary	Satisfaction and acceptability	Self report questionnaire	At 1 day prior to scheduled surgery
Secondary	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