Hypertension is an risk factor for cognitive impairment. The primary objective of this study is to evaluate the efficacy of 12-week computerized cognitive training in people with hypertension and mild cognitive impairment. The researchers will further investigate the long-term effects of cognitive training by prolonging the intervention for 24 weeks among a randomly selected sub-group.
This study is a double-blinded, randomized controlled trial. A total of 200 hypertension patients with mild cognitive impairment will be recruited to participate in this study after screening. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
The multi-domain adaptive cognitive training covers seven aspects of fundamental cognitive function, including sensory perception, cognitive flexibility, attention, memory, language, logic calculation, and emotion recognition and management. A self-adaptive algorithm is embedded in the tablet-based cognitive training platform, which will help deliver suitable tasks at the right difficulty level for each participant according to their personal profile and real-time performance. The intervention dosage is 30 minutes per time, 5 times a week.
The basic cognitive training for the control arm will also be delivered via a tablet. The training tasks will be fixed at a primary difficulty level without adaptive algorithm. The intervention dosage is also 30 minutes per time, 5 times a week.
Beijing Anzhen Hospital
Beijing, China
Ruijing Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
Global cognitive function change measured by BCAT in 12 weeks
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.
Time frame: 12 weeks after randomization
Global cognitive function change measured by BCAT in 24 weeks
The proportion of patients whose global cognitive function improves 0.67SD compared to the baseline cognitive function at 24 weeks measured by Basic Cognitive Ability Test(BCAT).
Time frame: 24 weeks after randomization
Sub-domain cognitive function improvement including memory, attention, and execution memory
The proportion of patients whose sub-domain cognitive function, including attention, memory, execution function improves measured by the individual capability test in BCAT.
Time frame: 12 weeks, 24 weeks after randomization
Cognitive score change
Mean change from baseline in global cognitive function score measured by basic cognitive ability test (BCAT) at 12 weeks and 24 weeks.
Time frame: 12 weeks, 24 weeks after randomization
Self-efficacy score
Mean change from baseline in self-efficacy score measured by the General Self-Efficacy Scale at 12 weeks, and 24 weeks
Time frame: 12 weeks, 24 weeks after randomization
Quality of life score
Mean change from baseline in the patient's quality of life score measured by EQ-5D-3L at 12 weeks and 24 weeks.
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Time frame: 12 weeks, 24 weeks after randomization
Anxiety score
Mean change from baseline in the patient's anxiety score at 12 weeks and 24 weeks. Anxiety status will be measured by GAD-7 questionnaire. Higher score of GAD-7 scale represents more anxiety status.
Time frame: 12 weeks, 24 weeks after randomization
Depression score
Mean change from baseline in the patient's depression score at 12 weeks and 24 weeks. Depression status will be measured by PHQ-9 questionnaire. Higher score of PHQ-9 scale represents more depression status.
Time frame: 12 weeks, 24 weeks after randomization