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Completed

NCT Number: NCT05298540

Feasibility and Acceptability of Home-based Computerised Cognitive Training After Cardiac Surgery

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.

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Key information

Conditions

Postoperative Cognitive Dysfunction Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Cognitive Complications Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Barts Health NHS Trust

London, EC1A 7DN, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥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.

Exclusion criteria

  • 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

Treatment and study plan

Home-based computerised cognitive training with BrainHQ

Behavioral

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.

Primary outcomes

  1. Recruitment rate

    Time frame: 6 months

    Number of participants included from eligible patients; satisfactory recruitment defined as enrolment of ≥ 50% of eligible patients.

  2. Study retention

    Time frame: 6 months

    Satisfactory retention rate ≥ 75% of participants completing the 8-week training programme

  3. Recruitment target

    Time frame: 6 months

    The time required to meet the target recruitment of 30 patients

  4. Feasibility of testing procedures

    Time frame: 6 months

    % of participants where outcome testing was completed

  5. Feasibility of data collection methods

    Time frame: 6 months

    % of participants with complete data sets

  6. 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

  7. 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

  8. 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.

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.

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Barts & The London NHS Trust

Other

Registry information

Acronym: FACCT

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 28, 2022
Registry last updated
Apr 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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