Trials · 2025
The efficacy of computerized cognitive training in patients with coronary heart disease and cognitive impairment, no dementia: study protocol for a randomized controlled trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод пока не подготовлен
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Ye Yi, Chen Qing, Li Ruixuan, Wang Xiaoyi, Sun Yueling, Li Fangjiang, Liu Xiaoping, Wang Le, Ning Xinhui, Tian Hongsen, Zhao Wei, Ma Changsheng, Zhang Hongjia, Zeng Yong
Аннотация
BACKGROUND: Cognitive training has been confirmed to significantly improve the overall cognitive function in patients. For patients with coronary heart disease, in addition to controlling common risk factors, there is a lack of effective evidence for the treatment of cognitive function in patients with coronary heart disease and its effectiveness. This randomized controlled study was designed to evaluate the effectiveness of computer-based cognitive training for improving cognitive function in such patients.
METHODS: COG-T CHD is a multicenter, double-blind, parallel-designed, randomized controlled trial. The patients will be divided 1:1 into two groups by a central randomized system, a cognitive digital therapy group or a positive control group. Patients assigned to the cognitive digital therapy group will undergo computer-based cognitive training for 30 min at least five 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 12 weeks of cognitive digital therapy training and the other group stopped the training. Patients assigned to the positive control group will undergo computer-based cognitive training with little or no difficulty changes for 30 min at least five times a week for 12 weeks. The study will last approximately 2 years, with enrollment completed in approximately 18 months, with the last enrolled patient followed for at least 24 weeks. The primary outcome is the proportion of improvement in overall cognitive function at 12 weeks, using the Basic Cognitive Ability Test (BCAT). Secondary outcomes are the proportion of improvement in the overall cognitive function from baseline at 24 weeks, the change in overall cognitive function scores at 12 and 24 weeks, and the proportion of improvement in each cognitive domain, General Self-Efficacy Scale score, EuroQol five-dimension three-level questionnaire score, and Generalized Anxiety Disorder-7 score at 12 and 24 weeks from baseline. The investigational outcome is the change in head MRI structure and function from baseline at weeks 12/24.
DISCUSSION: COG-T CHD is the first clinical trial to evaluate the efficacy of computer-based cognitive training in patients with coronary heart disease, filling an important gap in the treatment evidence for cognitive digital therapy.
TRIAL REGISTRATION: ClinicalTrials.gov, NCT05735041. Registered on Jan. 18, 2023.
METHODS: COG-T CHD is a multicenter, double-blind, parallel-designed, randomized controlled trial. The patients will be divided 1:1 into two groups by a central randomized system, a cognitive digital therapy group or a positive control group. Patients assigned to the cognitive digital therapy group will undergo computer-based cognitive training for 30 min at least five 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 12 weeks of cognitive digital therapy training and the other group stopped the training. Patients assigned to the positive control group will undergo computer-based cognitive training with little or no difficulty changes for 30 min at least five times a week for 12 weeks. The study will last approximately 2 years, with enrollment completed in approximately 18 months, with the last enrolled patient followed for at least 24 weeks. The primary outcome is the proportion of improvement in overall cognitive function at 12 weeks, using the Basic Cognitive Ability Test (BCAT). Secondary outcomes are the proportion of improvement in the overall cognitive function from baseline at 24 weeks, the change in overall cognitive function scores at 12 and 24 weeks, and the proportion of improvement in each cognitive domain, General Self-Efficacy Scale score, EuroQol five-dimension three-level questionnaire score, and Generalized Anxiety Disorder-7 score at 12 and 24 weeks from baseline. The investigational outcome is the change in head MRI structure and function from baseline at weeks 12/24.
DISCUSSION: COG-T CHD is the first clinical trial to evaluate the efficacy of computer-based cognitive training in patients with coronary heart disease, filling an important gap in the treatment evidence for cognitive digital therapy.
TRIAL REGISTRATION: ClinicalTrials.gov, NCT05735041. Registered on Jan. 18, 2023.