NCT02053207

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 3, 2014

Completed
3.9 years until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

December 2, 2017

Status Verified

November 1, 2017

Enrollment Period

10 months

First QC Date

January 20, 2014

Last Update Submit

November 29, 2017

Conditions

Postoperative Cognitive Dysfunction

Keywords

Cognitive trainingBrain trainingPlasticity-based trainingCardiac surgeryPreoperativeCognitive function

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Recruitment and retention

    10 weeks

  • Satisfaction and acceptability

    At 1 day prior to scheduled surgery

  • Side-effects

    From 21 days prior to scheduled surgery to up to 14 days after surgery

Study Arms (1)

Cog-Train Intervention

EXPERIMENTAL
Behavioral: Cog-Train Intervention

Interventions

Cog-Train InterventionBEHAVIORAL

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.

Cog-Train Intervention

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled for elective cardiac surgery with cardiopulmonary bypass at Papworth Hospital
  • Aged 60+ years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Papworth Hospital NHS Foundation Trust

Cambridge, Cambridgeshire, CB23 3RE, United Kingdom

Location

Related 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.

    PMID: 21949712BACKGROUND

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Alain Vuylsteke, MD

    Papworth Hospital NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberly Giraud, PhD

CONTACT

01480 830541kimberly.giraud@papworth.nhs.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2014

First Posted

February 3, 2014

Study Start

January 1, 2018

Primary Completion

November 1, 2018

Study Completion

December 1, 2018

Last Updated

December 2, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)