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

NCT05298540 | Completed

• 1 other identifier: 309731
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Cognitive Dysfunction

Keywords

Cognitive intervention; Cardiac surgery; Feasibility; Acceptability

Outcome Measures

Primary Outcomes (8)

• Recruitment rate

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

  6 months

• Study retention

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

  6 months

• Recruitment target

  The time required to meet the target recruitment of 30 patients

  6 months

• Feasibility of testing procedures

  % of participants where outcome testing was completed

  6 months

• Feasibility of data collection methods

  % of participants with complete data sets

  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

  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

  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 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.

  6 months

Study Arms (1)

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

Behavioral: Home-based computerised cognitive training with BrainHQ

Interventions

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.

Home-based computerised cognitive training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Barts & The London NHS Trust: lead

Study Sites (1)

Barts Health NHS Trust

London, EC1A 7DN, United Kingdom

Location

MeSH Terms

Conditions

Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

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

Study Officials

• Tracey Bowden, MSc

  Barts & The London NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 28, 2022
• Study Start: August 1, 2022
• Primary Completion: December 22, 2022
• Study Completion: December 22, 2022
• Last Updated: April 5, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)