Randomised Clinical Trial to Evaluate the Efficacy of an Online Cognitive Rehabilitation Programme (COPERIA-COG) for Patients With Persistent COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 88
- 试验地点
- 4
- 主要终点
- RAVLT Rey Auditory Verbal Learning Test
研究概览
简要总结
The pandemic caused by SARS-CoV-2 infection has led to the emergence of diffuse and heterogeneous persistent symptoms in addition to the well-known acute symptoms, which have come to be referred to as persistent COVID. In particular, one of the frequent complaints of patients with a previous diagnosis of COVID is impaired cognitive ability.
Various cognitive rehabilitation programmes have benefited from incorporating the methodology of so-called "serious games" are designed to train or change behaviour while entertaining players. The design of the online rehabilitation programme (COPERIA-COG) took into account the principles of neuropsychological rehabilitation (neuropsychological pre-assessment, operational goal setting, task prioritisation and continuous feedback system) and combined different individual techniques, such as restitution and compensation. Patients treated with COPERIA-COG will show neuropsychological improvements in verbal memory compared to the waiting list group.
The main objective is to identify differences in long-term memory in patients treated with COPERIA-COG vs. patients on the waiting list. For this purpose, both groups will be evaluated through RAVLT, taking the long-term memory subtest as a reference, comparing the results before and after the active group performs the online training with COPERIA-COG.
The COPERIA platform is a cloud platform that provides a range of ICT tools for monitoring and aiding the recovery of patients with persistent COVID. To achieve this goal, the platform will store patient data to which Artificial Intelligence techniques will be applied to perform an assessment of the affected person.
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
- Single (Outcomes Assessor)
盲法说明
The investigator performing the analysis will be blinded to which group is the active intervention group.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 and ≤70 years old.
- •Read and write.
- •Diagnosis of persistent COVID according to WHO criteria.
- •The patient reports cognitive dysfunction with self-assessed impact of at least grade 2 on the Post-Covid Functional Status (Chile) (Klok et al., 2020, Lorca et al., 2021).
- •The patient does not present cognitive dysfunction to a degree equal to or greater than 1.5 SD assessed in the psychology consultation by means of the following instruments: RAVLT Rey Auditory Verbal Learning Test (Schmidt, 1996). Subtests of the Number Key, Symbol Search and Digit Span of the Scale for Measuring Adult and Adolescent Intelligence (WAIS III) (Wechsler, 1999). TMT Stroke Test (Reitan & Wolfson, 1993). Verbal fluency tests (Benton et al., 1989). In case of scores above 1.5 SD below the normative mean, they will be excluded from the study and referred for treatment to the Brain Injury Unit (Winblad et al., 2004).
- •Patients with capacity to consent and agree to participate in the study.
- •Patients who know how to use and have a Smartphone or Tablet and an Internet connection.
排除标准
- •Minors or persons legally incapacitated.
- •Previous neurological or psychiatric pathology involving neuropsychological compromise.
- •Active Covid19 infection.
- •Home oxygen therapy > 16 hours or home CPAP-BiPAP.
- •Be undergoing another cognitive rehabilitation process at the time of inclusion.
结局指标
主要结局
RAVLT Rey Auditory Verbal Learning Test
时间窗: 8 weeks
An instrument that has proven useful in assessing verbal learning and memory. Easily administered test that assesses immediate memory span, new learning, susceptibility to interference and recognition memory.
次要结局
- Trail Making Test (TMT)(8 weeks)
- Memory Failures Everyday-30 (MFE-30)(8 weeks)
- Hospital Anxiety and Depression Scale (HADS Scale)(8 weeks)
- Subtests of the Number Key, Symbol Search and Digit Search Scale for Measuring Adult and Adolescent Intelligence (WAIS III)(8 weeks)
- Verbal fluency tests(8 weeks)
- Adherence to online treatment(8 weeks)