The objective of the study is to evaluate the effectiveness of cognitive training in people with atrial fibrillation and cognitive decline over 12-week cognitive training. Moreover, the investigators will explore whether the training effect can be maintained.
Introduction: Cognitive impairment is a clinical condition characterized of a reduction in memory and/or other cognitive processes that are insufficiently severe to be diagnosed as dementia.The prevalence of dementia among people over 65 years old in China is 5.14% , while the prevalence of mild cognitive impairment is 20.8%. The risk of cognitive impairment and dementia in patients with atrial fibrillation is significantly higher than that those in the same age group, even after adjusted stroke and other common risk factors such as hypertension and diabetes. At present, the effectiveness of cognitive training in patients with atrial fibrillation complicated with cognitive impairment is not clear. Objectives: The objective of the study is to evaluate whether cognitive training could lead cognitive improvement in patients with cognitive impairment and atrial fibrillation. Patients and Methods: The proposed study is a double blinded, randomized and controlled trial that will include 200 patients with cognitive impairment and atrial fibrillation. The groups will be randomized to either intervention or active-control group. Both groups will receive computerized cognitive training performed for 30 minutes x 5 times/week over 12 weeks. A neuropsychological assessment will be administered at baseline and week 12 and 24 after the intervention. The structural and functional MRI will be performed at baseline and week 12 after intervention for a sub-study on the effect of cognitive training on brain structure and function.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
tablet-based cognitive training for 12 weeks, 30 minutes each time, at least 5 times a week
tablet-based cognitive training tasks with weak or no difficulty changes, 5 times a week, 30 minutes each time for 12 weeks
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China
global cognitive change in 12 weeks
The percentage of patients whose global cognitive function measured at 12 weeks after intervention improves 0.67 SD compared to that measured at baseline by basic cognitive ability test (BCAT)
Time frame: 12 weeks after randomization
global cognitive change in 24 weeks
The percentage of patients whose global cognitive function improved at 24 weeks
Time frame: 24 weeks after randomization
domain cognitive change
The percentage of patients whose cognitive function improved in any domain at 12 weeks and at 24 weeks;
Time frame: 12 weeks, 24 weeks after randomization
cognitive score change
Changes in global cognitive function scores at 12 weeks and at 24 weeks
Time frame: 12 weeks, 24 weeks after randomization
self-efficacy scores
Changes in the patient's self-efficacy scores compared with baseline at 12 weeks and at 24 weeks. The General Self-Efficacy scale ranged from 10 to 40, and higher scores mean better self-efficacy.
Time frame: 12 weeks, 24 weeks after randomization
quality of life scores
Changes in the patient's quality of life scores compared with baseline at 12 weeks and at 24 weeks. quality of life will be measured using EQ-5D-3L(EuroQol 5-Dimensional 3 level version).
Time frame: 12 weeks, 24 weeks after randomization
anxiety and depression scores
Changes in the patient's anxiety and depression scores compared with baseline at 12 weeks and at 24 weeks. Anxiety status will be measured using the GAD-7 questionnaire which ranges from 0 to 21, with a higher score representing more anxiety. Depression status will be measured using the PHQ-9 questionnaire which ranges from 0 to 27, with a higher score representing more depression.
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Time frame: 12 weeks, 24 weeks after randomization