Feasibility and Acceptability of Home-based Computerised Cognitive Training After Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility of testing procedures
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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.
排除标准
- •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
研究组 & 干预措施
Home-based computerised cognitive training
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
干预措施: Home-based computerised cognitive training with BrainHQ (Behavioral)
结局指标
主要结局
Feasibility of testing procedures
时间窗: 6 months
% of participants where outcome testing was completed
Feasibility of data collection methods
时间窗: 6 months
% of participants with complete data sets
Adherence to the intervention: total time
时间窗: 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
Recruitment rate
时间窗: 6 months
Number of participants included from eligible patients; satisfactory recruitment defined as enrolment of ≥ 50% of eligible patients.
Adherence to the intervention: number of sessions
时间窗: 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
Study retention
时间窗: 6 months
Satisfactory retention rate ≥ 75% of participants completing the 8-week training programme
Recruitment target
时间窗: 6 months
The time required to meet the target recruitment of 30 patients
Acceptability, by participant report
时间窗: 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.
次要结局
- 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)