Clinical trial NCT05298540: Feasibility and Acceptability of Home-based Computerised Cognitive Training After Cardiac Surgery
Official title: Feasibility and Acceptability of Home-based Computerised Cognitive Training After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Cognitive Dysfunction
Keywords: Cognitive intervention
Cardiac surgery
Feasibility
Acceptability
Lead sponsor: Barts & The London NHS Trust
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment rate
timeFrame: 6 months
measure: Study retention
timeFrame: 6 months
measure: Recruitment target
timeFrame: 6 months
measure: Feasibility of testing procedures
timeFrame: 6 months
measure: Feasibility of data collection methods
timeFrame: 6 months
measure: Adherence to the intervention: number of sessions
timeFrame: 6 months
measure: Adherence to the intervention: total time
timeFrame: 6 months
measure: Acceptability, by participant report
timeFrame: measured after the 8 week intervention (ie 8-10 weeks)
Secondary outcomes:
measure: to estimate measures of precision about the mean and variance of cognitive outcome to inform sample size calculations for a subsequent efficacy study.
timeFrame: 6 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Barts Health NHS Trust
Study officials:
affiliation: Barts & The London NHS Trust
name: Tracey Bowden, MSc
role: PRINCIPAL_INVESTIGATOR
References: