Postoperative Cognitive DysfunctionCog-TrainNCT02053207
Feasibility Study of Preoperative Cognitive Training in Cardiac Surgical Patients
A study testing Cog-Train Intervention in people with Postoperative Cognitive Dysfunction, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Postoperative Cognitive Dysfunction
- What is being tested?
- Cog-Train Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2018to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for elective cardiac surgery with cardiopulmonary bypass at Papworth Hospital
- Aged 60+ years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Papworth Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, CB23 3RE
About this study
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
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.
Read the 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.
- Conditions
- Postoperative Cognitive Dysfunction
- Being tested
- Cog-Train Intervention
- Keywords
- Cognitive training, Brain training, Plasticity-based training, Cardiac surgery, Preoperative, Cognitive function
- Medical subject headings
- Postoperative Cognitive Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cog-Train InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cog-Train Intervention | Experimental | Not described Receives: Behavioral: Cog-Train Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Training performance gain
Average increase in training task level achieved from first to last training day
Measured: 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
Measured: From 21 days prior to scheduled surgery to 1 day prior to scheduled surgery
Secondary outcomes (3)
Recruitment and retention
Proportion of patients approached who can do the task and are willing to take part
Measured: 10 weeks
Satisfaction and acceptability
Self report questionnaire
Measured: At 1 day prior to scheduled surgery
Side-effects
Side effects and severity reported by patients and proportion of patients who reported side-effects
Measured: From 21 days prior to scheduled surgery to up to 14 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2014 (estimated)
- Study startJan 2018 (estimated)
- Primary completionNov 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Cognitive DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Papworth Hospital NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- Medical Research Council Cognition and Brain Sciences Unit
- Responsible party
- Sponsor
- Investigators
- Alain Vuylsteke, MD, Principal investigator, Papworth Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02053207
- Sponsor's protocol ID
- P01907
- Acronym
- Cog-Train
- Status last verified
- Nov 2017
- First submitted
- 20 Jan 2014
- Last updated
- 2 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 21949712
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02053207
- Acronym / sponsor ID
- Cog-Train / P01907
- Conditions
- Postoperative Cognitive Dysfunction
- Keywords
- Cognitive training, Brain training, Plasticity-based training, Cardiac surgery, Preoperative, Cognitive function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Papworth Hospital NHS Foundation TrustOther government
- Collaborators
- Medical Research Council Cognition and Brain Sciences Unit
- Study start
- Jan 2018 (estimated)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 3 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cog-Train Intervention | Experimental | Behavioral: Cog-Train Intervention |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled for elective cardiac surgery with cardiopulmonary bypass at Papworth Hospital
- Aged 60+ years
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cog-Train InterventionTwenty-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. | Behavioural | Cog-Train Intervention |
Primary outcome
Training performance gain
Time frame: From 21 days prior to scheduled surgery to 1 day prior to scheduled surgery
Average increase in training task level achieved from first to last training day
Adherence to training regimen
Time frame: From 21 days prior to scheduled surgery to 1 day prior to scheduled surgery
Mean number of training days completed according to instructions
3 secondary outcomes
Recruitment and retention
Time frame: 10 weeks
Satisfaction and acceptability
Time frame: At 1 day prior to scheduled surgery
Side-effects
Time frame: From 21 days prior to scheduled surgery to up to 14 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2017.
- Background: PubMed 21949712Schweizer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain Vuylsteke, MD principal investigator
Papworth Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cog-Train Intervention in people with Postoperative Cognitive Dysfunction, run by Papworth Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kimberly Giraud, PhD (01480 830541, kimberly.giraud@papworth.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Training performance gain (time frame: From 21 days prior to scheduled surgery to 1 day prior to scheduled surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02053207, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2017.