Neuropsychological Sequelae as a Risk Factor for Long COVID-19 Fatigue
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- Prevalence of fatigue in patients with post-COVID-19 post-traumatic stress disorder
研究概览
简要总结
An association of fatigue with post-viral neuropsychological disturbs has been reported. Among patients hospitalized with COVID-19 there is an increased incidence of anxiety and depression symptoms. In addition, a quarter of patients experience at least mild symptoms of acute post traumatic stress disorder. (Mazza, M. G. et al 2020). The prevalence of chronic fatigue syndrome had a correlation with post-traumatic stress disorder (PTSD) in a study conducted after the outbreak of the COVID-19 in Iran (Silmani et al, 2021), that showed 5.8% of subjects suffering from PTSD after 6 months of SARS-CoV-2 infection onset.
In this Study we propose to use a tool to quantify the degree of physical and psychological fatigue in post-COVID-19 patients, and assess the correlation of fatigue with the neuropsychiatric sequelae in hospitalized and non hospitalized patients.
详细描述
This study will address the neuropsychiatric sequelae that remain for at least 6 months after SARS-CoV-2 acute infection, as depression, anxiety and/or post-traumatic stress disorder.
The patiensts will be assessed at the post-COVID-19 outpatient clinics of five Portuguese Hospitals. In the first visit (T1) will be collected the demographic characteristics; the medical history; and the screening of acute disease symptoms and severity. In the second visit (T2), the time frame will be at least 6 months after the positive test and no longer than 9 months, a set of structured questionnaires will be provided, including: the Chalder Fatigue Scale, Anxiety and Depression Hospital Scale (HADS), The Posttraumatic Stress Symptoms-14 (PTSS-14) adapted to COVID-19 and the EuroQol 5-Dimensions (EQ-5D).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years;
- •Previous COVID-19 at least six months after the diagnosis duly documented in the clinical record;
- •Persistent symptoms after cure criteria defined by WHO Symptomatic patients that attend the post-COVID-19 follow-up consultation of the study centres.
- •SARS-CoV-2 RNA confirmed by a positive real-time reverse-transcription polymerase chain reaction on a nasopharyngeal swab.
- •SARS-CoV-2 antigen confirmed on a nasopharyngeal swab, by a healthcare professional.
排除标准
- •Patients with PTSD previous diagnosis
- •Severe psychiatric disorders documented in the clinical record
- •Patients not able to respond the questionnaire
- •Patients who had a concomitant severe neurological disorder
- •Clinical and radiological diagnosis of Stroke with sequelae
- •Clinical diagnosis of Alzheimer's Disease
- •Clinical diagnosis of Parkinson's disease
- •Patients with persistent fatigue symptoms in the 6 months before SARS-CoV 2 infection
结局指标
主要结局
Prevalence of fatigue in patients with post-COVID-19 post-traumatic stress disorder
时间窗: 6-9 months
Fatigue will be assessed with the Chalder fatigue scale (global and binary score). PTSD will be assessed with the Post-Traumatic Stress Syndrome 14 Questions Inventory (PTSS-14) adapted to COVID-19: - Positive case between 46-98 points
Prevalence of fatigue in patients with post-COVID-19 depression and/or anxiety
时间窗: 6-9 months
Fatigue will be assessed with the Chalder fatigue scale: - Global score (0-33), that also spans two dimensions-physical fatigue (measured by items 1-7) and psychological fatigue (measured by items 8-11). This is a Likert scoring system that allows for means and distributions to be calculated for both the global total as well as the two sub-scales. Depression and anxiety will be assessed with the Hospital Anxiety and Depression Scale * Depression HADS subscale scoring: Normal 0-7; Boderline abnormal 8-10; Abnormal 11-21 * Anxiety HADS subscale scoring: Normal 0-7; Borderline 8-10; Abnormal 11-21
次要结局
- Impact of post-COVID-19 neuropsychological sequelae in quality of life(6-9 months)
- Impact of post-COVID-19 fatigue in quality of life.(6-9 months)
- Evaluate if neuropsychological are associated with severity of acute COVID-19(6-9 months)
研究者
Ligia Pires
Principal Investigator
Centro Hospitalar Universitario do Algarve