Postoperative Cognitive DysfunctionFACCTNCT05298540
Feasibility and Acceptability of Home-based Computerised Cognitive Training After Cardiac Surgery
A study testing Home-based computerised cognitive training with BrainHQ in people with Postoperative Cognitive Dysfunction, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
The aims of this study are to (1) evaluate the feasibility and acceptability of a home-based computerised cognitive training programme in the postoperative cardiac surgical population, and (2) estimate measures of precision about the mean and variance of cognitive outcome to inform sample size calculations for a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Cognitive Dysfunction
- What is being tested?
- Home-based computerised cognitive training with BrainHQ
- 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
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2022to 22 Dec 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years old undergoing first time elective cardiac surgery
- Willing to engage with an online cognitive training programme
- Access to a computer or table with access to the internet.
Who cannot join
- Unwilling or unable to give written informed consent
- significant psychiatric or medical comorbidities where that condition might impact on cognitive function and affect their ability to participate.
- Inability to understand written and / or verbal English
- Those with motor symptoms that would impede their ability to complete the programme
- Those unwilling or unable to engage in a video call
Trial locations and contacts
1 site in 1 country.
About this study
The aims of this study are to (1) evaluate the feasibility and acceptability of a home-based computerised cognitive training programme in the postoperative cardiac surgical population, and (2) estimate measures of precision about the mean and variance of cognitive outcome to inform sample size calculations for a subsequent efficacy study.
Read the detailed description
Heart surgery is a common procedure for coronary heart disease (blocked or narrowed coronary arteries) and valve problems (narrowing or hardening of the heart valves). It is known that after surgery some patients experience problems with their 'cognitive health' - this includes aspects like memory problems, concentration, and attention. These cognitive health problems can last for several months and can have a considerable impact on patients, and their family.
Cognitive training (which means exercising the brain) has been shown to improve cognitive health in a number of patient groups including healthy older adults, patients with heart failure, and patients with mild cognitive impairment. The aim of this study is to find out if home-based computerised cognitive training (CCT) improves cognitive health after heart surgery.
Investigators will recruit adult (≥ 18 years) patients undergoing first time elective cardiac surgery, who are willing to engage with an online training programme, and due to the nature of the intervention, potential participants must have access to a computer or tablet and access to the internet.
Before surgery, a brief cognitive assessment will be carried out. Participants will be asked to complete 20 minutes of cognitive training exercises, 5 days per week, starting one week after their operation. A member of the research team will contact the patient once a week to check progress, to provide support, and to help with any technical issues.
After the 8-week CCT (brain training exercises) programme, a follow-up video call will be arranged. During this follow-up participants will complete a second cognitive assessment and a questionnaire to see how acceptable and helpful they found the brain training exercises.
- Conditions
- Postoperative Cognitive Dysfunction
- Being tested
- Home-based computerised cognitive training with BrainHQ
- Keywords
- Cognitive intervention, Cardiac surgery, Feasibility, Acceptability
- 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.
Home-based computerised cognitive training with BrainHQBehavioural
Participants will be registered for individual accounts to an online CCT program created by BrainHQ (Posit Science, San Francisco), that can be administered using their own computer or tablet. BrainHQ has been associated with improvements in memory, attention, and processing speed. The program will be customised to target domains thought to be deficient in the postoperative period and will include training in memory, attention, and processing speed. Specifically, the following six games have been selected: hear, hear (auditory memory and attention), to-do list training (working memory), divided attention (attention), target tracker (attention), double decision (useful field of view and visual processing speed), and eye for detail (visual processing speed and visual working memory). The exercises are adaptive, adjusting the application difficulty to the participants performance.
| Study group | Role | What they receive |
|---|---|---|
| Home-based computerised cognitive training | Experimental | Participants will be asked to complete 40 sessions (20 minutes / day, 5 days / week) of cognitive training over the 8-week intervention period (this will be assessed using automated data reports of user activity generated in collaboration with BrainHQ). Training will commence one week postoperatively to avoid the effects of sedatives, postoperative pain, sleep deprivation, and patient fatigue, and to improve adherence Receives: Behavioral: Home-based computerised cognitive training with BrainHQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Number of participants included from eligible patients; satisfactory recruitment defined as enrolment of ≥ 50% of eligible patients.
Measured: 6 months
Study retention
Satisfactory retention rate ≥ 75% of participants completing the 8-week training programme
Measured: 6 months
Recruitment target
The time required to meet the target recruitment of 30 patients
Measured: 6 months
Feasibility of testing procedures
% of participants where outcome testing was completed
Measured: 6 months
Feasibility of data collection methods
% of participants with complete data sets
Measured: 6 months
Adherence to the intervention: number of sessions
Compliance to measure the feasibility of the study; the number of sessions completed out of the 40 planned sessions during the 8-week intervention
Measured: 6 months
Adherence to the intervention: total time
Compliance to measure the feasibility of the study; the total time completed out of the planned 800 minutes during the 8-week intervention
Measured: 6 months
Acceptability, by participant report
The theoretical framework of acceptability (TFA) questionnaire has been adapted to this study, in collaboration with one of the TFA development team, to evaluate participants' perceptions of the intervention. The questionnaire was designed to inductively evaluate the retrospective acceptability of the intervention. The seven-item questionnaire will provide a five-point Likert scale reporting method in relation to their agreement statements, where the minimum value is 5 and maximum value is 35, with a higher score indicating higher acceptability.
Measured: measured after the 8 week intervention (ie 8-10 weeks)
Secondary outcomes (1)
to estimate measures of precision about the mean and variance of cognitive outcome to inform sample size calculations for a subsequent efficacy study.
Cognitive function will be measured using the Montreal Cognitive Assessment (MoCA). The MoCA is a brief, 30-question test of global cognition, designed to detect mild cognitive impairment with a high degree of sensitivity and specificity. The MoCA takes approximately 10 minutes to administer, and will be measured upon enrolment and after the 8-week intervention. A score of 26 (out of 30) or higher is considered normal.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start1 Aug 2022
- Primary completion22 Dec 2022
- Study completion22 Dec 2022
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tracey Bowden, MSc, Principal investigator, Barts & The London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298540
- Sponsor's protocol ID
- 309731
- Acronym
- FACCT
- Status last verified
- Apr 2023
- First submitted
- 7 Mar 2022
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share the data consistent with ethics approvals and consent.
Publications
Bowden T, Sanders J, Hurt CS, Sekhon M, Aitken LM. Feasibility and acceptability of home-based computerised cognitive training after cardiac surgery. Pilot Feasibility Stud. 2026 Jul 16. doi: 10.1186/s40814-026-01882-y. Online ahead of print.
PubMed 42458626
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Home-based Computerised Cognitive Training After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05298540
- Acronym / sponsor ID
- FACCT / 309731
- Conditions
- Postoperative Cognitive Dysfunction
- Keywords
- Cognitive intervention, Cardiac surgery, Feasibility, Acceptability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 28 Mar 2022 (actual)
- 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 aims of this study are to (1) evaluate the feasibility and acceptability of a home-based computerised cognitive training programme in the postoperative cardiac surgical population, and (2) estimate measures of precision about the mean and variance of cognitive outcome to inform sample size calculations for a subsequent efficacy study.
Detailed description
Heart surgery is a common procedure for coronary heart disease (blocked or narrowed coronary arteries) and valve problems (narrowing or hardening of the heart valves). It is known that after surgery some patients experience problems with their 'cognitive health' - this includes aspects like memory problems, concentration, and attention. These cognitive health problems can last for several months and can have a considerable impact on patients, and their family.
Cognitive training (which means exercising the brain) has been shown to improve cognitive health in a number of patient groups including healthy older adults, patients with heart failure, and patients with mild cognitive impairment. The aim of this study is to find out if home-based computerised cognitive training (CCT) improves cognitive health after heart surgery.
Investigators will recruit adult (≥ 18 years) patients undergoing first time elective cardiac surgery, who are willing to engage with an online training programme, and due to the nature of the intervention, potential participants must have access to a computer or tablet and access to the internet.
Before surgery, a brief cognitive assessment will be carried out. Participants will be asked to complete 20 minutes of cognitive training exercises, 5 days per week, starting one week after their operation. A member of the research team will contact the patient once a week to check progress, to provide support, and to help with any technical issues.
After the 8-week CCT (brain training exercises) programme, a follow-up video call will be arranged. During this follow-up participants will complete a second cognitive assessment and a questionnaire to see how acceptable and helpful they found the brain training exercises.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home-based computerised cognitive training | Experimental | Behavioral: Home-based computerised cognitive training with BrainHQParticipants will be asked to complete 40 sessions (20 minutes / day, 5 days / week) of cognitive training over the 8-week intervention period (this will be assessed using automated data reports of user activity generated in collaboration with BrainHQ). Training will commence one week postoperatively to avoid the effects of sedatives, postoperative pain, sleep deprivation, and patient fatigue, and to improve adherence |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥18 years old undergoing first time elective cardiac surgery
- Willing to engage with an online cognitive training programme
- Access to a computer or table with access to the internet.
Key exclusion criteria (5 listed)
- Unwilling or unable to give written informed consent
- significant psychiatric or medical comorbidities where that condition might impact on cognitive function and affect their ability to participate.
- Inability to understand written and / or verbal English
- Those with motor symptoms that would impede their ability to complete the programme
- Those unwilling or unable to engage in a video call
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 |
|---|---|---|
| Home-based computerised cognitive training with BrainHQParticipants will be registered for individual accounts to an online CCT program created by BrainHQ (Posit Science, San Francisco), that can be administered using their own computer or tablet. BrainHQ has been associated with improvements in memory, attention, and processing speed. The program will be customised to target domains thought to be deficient in the postoperative period and will include training in memory, attention, and processing speed. Specifically, the following six games have been selected: hear, hear (auditory memory and attention), to-do list training (working memory), divided attention (attention), target tracker (attention), double decision (useful field of view and visual processing speed), and eye for detail (visual processing speed and visual working memory). The exercises are adaptive, adjusting the application difficulty to the participants performance. | Behavioural | Home-based computerised cognitive training |
Primary outcome
Recruitment rate
Time frame: 6 months
Number of participants included from eligible patients; satisfactory recruitment defined as enrolment of ≥ 50% of eligible patients.
Study retention
Time frame: 6 months
Satisfactory retention rate ≥ 75% of participants completing the 8-week training programme
Recruitment target
Time frame: 6 months
The time required to meet the target recruitment of 30 patients
Feasibility of testing procedures
Time frame: 6 months
% of participants where outcome testing was completed
Feasibility of data collection methods
Time frame: 6 months
% of participants with complete data sets
Adherence to the intervention: number of sessions
Time frame: 6 months
Compliance to measure the feasibility of the study; the number of sessions completed out of the 40 planned sessions during the 8-week intervention
Adherence to the intervention: total time
Time frame: 6 months
Compliance to measure the feasibility of the study; the total time completed out of the planned 800 minutes during the 8-week intervention
Acceptability, by participant report
Time frame: measured after the 8 week intervention (ie 8-10 weeks)
The theoretical framework of acceptability (TFA) questionnaire has been adapted to this study, in collaboration with one of the TFA development team, to evaluate participants' perceptions of the intervention. The questionnaire was designed to inductively evaluate the retrospective acceptability of the intervention. The seven-item questionnaire will provide a five-point Likert scale reporting method in relation to their agreement statements, where the minimum value is 5 and maximum value is 35, with a higher score indicating higher acceptability.
1 secondary outcome
to estimate measures of precision about the mean and variance of cognitive outcome to inform sample size calculations for a subsequent efficacy study.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Derived from this study: PubMed 42458626Bowden T, Sanders J, Hurt CS, Sekhon M, Aitken LM. Feasibility and acceptability of home-based computerised cognitive training after cardiac surgery. Pilot Feasibility Stud. 2026 Jul 16. doi: 10.1186/s40814-026-01882-y. Online ahead of print.
- Individual participant dataSharing planned: No. There are no plans to share the data consistent with ethics approvals and consent.
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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.
Tracey Bowden, MSc principal investigator
Barts & The London NHS 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 Home-based computerised cognitive training with BrainHQ in people with Postoperative Cognitive Dysfunction, run by Barts & The London NHS 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 5 Apr 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 6 months). The study lists 8 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 NCT05298540, 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 5 Apr 2023.