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临床试验/NCT05571852
NCT05571852已完成不适用

Before-and-after Study on the Impact of a Home-based Personalized Computerized Training Program on Cognitive Dysfunction Associated With Long COVID

Universidad Antonio de Nebrija1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2021年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
73
试验地点
1
主要终点
Cognitive Gains

研究概览

简要总结

This before-and-after study aims to evaluate the usefulness and efficacy of a personalized computerized cognitive training (CCT) to improve cognitive function among people with post-acute sequelae of COVID-19 (PASC).

详细描述

Through an online platform created for the study, adults who self-reported cognitive impairment more than 3 months after receiving a COVID-19 diagnosis will be enlisted and their cognitive status will be assessed using a commercially available test. After determining their level of general cognitive dysfunction, those who qualify and meet the inclusion criteria will be invited to use a customized computerized cognitive training (CCT) program at home and to complete as many daily training sessions as they would want over the course of eight weeks. The sessions will consist of gamified cognitively demanding exercises that target five cognitive skills: attention, coordination, memory, perception, and reasoning. Participants will also complete the general cognitive function assessment at the end of the intervention period, and the differences between the cognitive scores obtained before and after this period will be used as the main outcome measure. Additional analysis will be performed to better characterize the impact of the CCT by exploring the role of the age of the participants, their self-perceive health at baseline, the intensity of the training and the time from initial COVID-19 infection.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

  • •Adults (older than 18 years old).
  • •History of infection with COVID-19 at least 3 months prior to expression of interest.
  • •Presence of self-perceived cognitive dysfunction associated with PACS (concentration problems or brain fog).

排除标准

  • •Completion of less than 10 training sessions.
  • •Not completing the final evaluation after the 8-week training period.

研究组 & 干预措施

Computerized Cognitive Training

Experimental

Participants will be asked to complete short sessions of around 10 minutes each consisting of a variety of games designed to train the five cognitive skills (attention, memory, coordination, reasoning and perception). Each training session include two games selected among a pool of 12 different games. Participants will be asked to complete a training lasting for 8 weeks in which they could access the training platform as frequently as they wanted.

干预措施: CogniFit's CCT Post COVID-19 (Device)

结局指标

主要结局

Cognitive Gains

时间窗: 8 weeks

The difference in scores between the initial and final assessments as evaluated by the Cognitive Assessment Battery (CAB)™ PRO

次要结局

  • Intensity of the training(8 weeks)

研究者

发起方
Universidad Antonio de Nebrija
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jon Andoni Duñabeitia

Principal Investigator

Universidad Antonio de Nebrija

研究点 (1)

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