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

Primary Purpose

Postoperative Cognitive Dysfunction

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Home-based computerised cognitive training with BrainHQ
Sponsored by
Barts & The London NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Postoperative Cognitive Dysfunction focused on measuring Cognitive intervention, Cardiac surgery, Feasibility, Acceptability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Barts Health NHS Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Home-based computerised cognitive training

Arm Description

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

Outcomes

Primary Outcome Measures

Recruitment rate
Number of participants included from eligible patients; satisfactory recruitment defined as enrolment of ≥ 50% of eligible patients.
Study retention
Satisfactory retention rate ≥ 75% of participants completing the 8-week training programme
Recruitment target
The time required to meet the target recruitment of 30 patients
Feasibility of testing procedures
% of participants where outcome testing was completed
Feasibility of data collection methods
% of participants with complete data sets
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
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
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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 7, 2022
Last Updated
April 4, 2023
Sponsor
Barts & The London NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT05298540
Brief Title
Feasibility and Acceptability of Home-based Computerised Cognitive Training After Cardiac Surgery
Acronym
FACCT
Official Title
Feasibility and Acceptability of Home-based Computerised Cognitive Training After Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
December 22, 2022 (Actual)
Study Completion Date
December 22, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barts & The London NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Cognitive Dysfunction
Keywords
Cognitive intervention, Cardiac surgery, Feasibility, Acceptability

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Home-based computerised cognitive training
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Home-based computerised cognitive training with BrainHQ
Intervention Description
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 Outcome Measure Information:
Title
Recruitment rate
Description
Number of participants included from eligible patients; satisfactory recruitment defined as enrolment of ≥ 50% of eligible patients.
Time Frame
6 months
Title
Study retention
Description
Satisfactory retention rate ≥ 75% of participants completing the 8-week training programme
Time Frame
6 months
Title
Recruitment target
Description
The time required to meet the target recruitment of 30 patients
Time Frame
6 months
Title
Feasibility of testing procedures
Description
% of participants where outcome testing was completed
Time Frame
6 months
Title
Feasibility of data collection methods
Description
% of participants with complete data sets
Time Frame
6 months
Title
Adherence to the intervention: number of sessions
Description
Compliance to measure the feasibility of the study; the number of sessions completed out of the 40 planned sessions during the 8-week intervention
Time Frame
6 months
Title
Adherence to the intervention: total time
Description
Compliance to measure the feasibility of the study; the total time completed out of the planned 800 minutes during the 8-week intervention
Time Frame
6 months
Title
Acceptability, by participant report
Description
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.
Time Frame
measured after the 8 week intervention (ie 8-10 weeks)
Secondary Outcome Measure Information:
Title
to estimate measures of precision about the mean and variance of cognitive outcome to inform sample size calculations for a subsequent efficacy study.
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tracey Bowden, MSc
Organizational Affiliation
Barts & The London NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barts Health NHS Trust
City
London
ZIP/Postal Code
EC1A 7DN
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There are no plans to share the data consistent with ethics approvals and consent.

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

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