Design and Implementation of a Supervised Computerized Active Program (SuperCAP) for Improvement of Cognitive, Emotional, and Functional Status in People With Post-COVID Syndrome. SuperCAP Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Self-reported Cognitive Functioning
研究概览
简要总结
SuperCAP study is a project aimed at designing and implementing an online program for improvement of cognitive, emotional, and functional status in post-COVID condition.
详细描述
SuperCAP study will include 2 stages.
Stage 1 will involve the composition of a focus group previous to the effectiveness study development.
The work with this focus group will have several aims, among them, mainly, to participate in the design of the intervention program, and to provide feedback on the study follow-up.
Stage 2 will include the effectiveness study. This stage will comprise the initiation of the intervention program, study follow-up, and dissemination of the results in the end of the project.
Two study groups will participate: the Intervention Group and the Control Group.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presenting Post-COVID Syndrome, defined as presenting 3 or more symptoms associated with post-COVID condition for at least 3 months.
- •Age of 18-65 years old.
- •Presence of self-reported cognitive complaints associated with post-COVID infection.
- •Positive and favorable attitude on the use of electronic devices.
- •Will to participate in a stimulation program for improvement of cognitive symptoms.
- •Availability of cell phone and computer or tablet with the minimum technical features considered.
排除标准
- •Inability to undergo the neuropsychological tests or complementary study assessments.
- •Current participation in a trial or program for improvement of post-COVID symptoms.
- •Any condition that in the opinion of the investigator would make study participation unsafe, complicate interpretation of study outcome data, interfere with achieving the study objectives, or otherwise could impair the subject's ability to complete the study.
结局指标
主要结局
Change in Self-reported Cognitive Functioning
时间窗: From Baseline to Week 12
Understanding and Communicating Scale (D1) from WHODAS 2.0 questionnaire. Scores from 0 to 20. Lower scores indicate better functioning, higher scores worse functioning.
次要结局
- Change in Physical Activity(From Baseline to Week 12)
- Change in Depression Symptoms(From Baseline to Week 12)
- Change in Anxiety Symptoms(From Baseline to Week 12)
- Change in Daily Activities Functioning(From Baseline to Week 12)
- Change in Performance-based Cognitive Functioning(From Baseline to Week 12)
- Change in Quality of Life(From Baseline to Week 12)