The Efficacy of Computerized Cognitive Training in Patients With Coronary Heart Disease and Cognitive Impairment, no Dementia: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 224
- 试验地点
- 8
- 主要终点
- Global cognitive function change measured by BCAT in 12 weeks
研究概览
简要总结
In this study, a multicentre, double-blind, randomized controlled study based on cognitive training was conducted in patients with coronary heart disease and cognitive impairment but without dementia， to evaluate the effectiveness of computer-based digital therapy in improving the cognitive function of such patients.
详细描述
This study is a multicentre, double-blind, parallel randomized controlled study using a 1:1 parallel control design. A total of 200 patients with coronary heart disease combined with cognitive decline but no dementia were enrolled in 8 centres. These patients will be randomized to two arms under masking. The intervention arm will receive multi-domain adaptive cognitive training using a tablet. The control arm will receive an active control treatment and use the same tablet to receive the cognitive training tasks with weak difficulty change. Both arms will receive the same intervention dosage for 12 weeks, 5 times a week, and 30 minutes per time. After the 12-week intervention, the intervention arm will be re-randomized into two groups. One group will stop their intervention at 12 weeks; the other group will continue to receive the multi-domain adaptive cognitive training till the 24-week follow-up assessment. The neuro-psychological assessment will be administered at baseline, 12-week, and 24-week assessments for all participants. The structural and functional MRI will be administered at baseline, 12 weeks, and 24 weeks to evaluate the effect of cognitive training on brain structure and function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over the age of 50;
- •Completion of more than 6 years of education;
- •Patients with coronary artery disease confirmed by coronary CT angiography or coronary angiography;
- •Chief complaint of cognitive decline within 1 year;
- •The average score of any cognitive domain in processing speed, situational memory, working memory and visual space measured by the Basic Cognitive Ability Test (BCAT) is less than 1 SD compared with the normal population;
- •Agree to be randomized to cognitive function tests and cognitive training and be able to receive follow-up as required.
排除标准
- •Previous definite diagnosis of dementia or brief Mental State Examination Scale (MMSE) < 24 points;
- •Cognitive dysfunction caused by cranial trauma, cranial tumor, Parkinson's disease, schizophrenia, Alzheimer's disease, anxiety and depression, and other neuropsychiatric diseases;
- •Deaf and mute or other reasons cannot communicate normally;
- •Binge drinking or taking drugs (antihistamines, antipsychotics) that affect cognitive function;
- •Unable to master the use of cognitive training equipment after two 1-hour training instructions each time;
- •Patients who plan to undergo coronary intervention within 6 months or have undergone coronary intervention within 1 month;
- •Severe liver and kidney function injury or critical condition, poor prognosis, estimated survival of less than 1 month.
- •Patients who had received general anesthesia within 3 months;
- •History of stroke and craniocerebral trauma within 6 months;
- •History of Parkinson's disease, schizophrenia, and epilepsy;
- •Prior neurosurgery or history of cranial tumors;
- •Nuclear magnetic examination contraindications: such as metal implants, claustrophobia, etc.;
- •patients living alone;
- •Patients with atrial fibrillation, structural heart disease, and infective endocarditis.
研究组 & 干预措施
Cognitive digital therapy group
Computer-based cognitive training for 30 minutes at least 5 times a week for 12 weeks; At the end of the 12 weeks, the subjects were randomly divided into two groups. One group continued the training for 12 weeks, at least five times a week for 30 minutes each time, and the other group stopped the training.
干预措施: Multi-domain cognitive digital therapy (Behavioral)
Positive control group
Computer-based cognitive training tasks with low or no difficulty variation for 30 minutes at least five times a week for 12 weeks
干预措施: Basic cognitive therapy (Behavioral)
结局指标
主要结局
Global cognitive function change measured by BCAT in 12 weeks
时间窗: 12 weeks after randomization
The proportion of patients whose global cognitive function improves 0.67SD compared to the baseline cognitive function measured by Basic Cognitive Ability test (BCAT). BCAT is a set of neuropsychological battery tests which was designed to measure global cognitive fucntion and cognitive function of sub-domains. Higher scores of BCAT means a better global cognitive function.
次要结局
- Global cognitive function change measured by BCAT in 24 weeks(24 weeks after randomization)
- Cognitive score change(12 weeks, 24 weeks after randomization)
- Self-efficacy score(12 weeks, 24 weeks after randomization)
- Quality of life score(12 weeks, 24 weeks after randomization)
- Sub-domain cognitive function improvement including memory, attention, and execution memory(12 weeks, 24 weeks after randomization)
- Anxiety score(12 weeks, 24 weeks after randomization)
- Depression score(12 weeks, 24 weeks after randomization)
研究者
Yong Zeng
Professor
Beijing Anzhen Hospital