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| Name | Class |
|---|---|
| Universidade do Algarve | OTHER |
| Universidade do Porto | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neuropsychological Sequelae | Post-COVID-19 symptomatic patients with neuropsychological sequelae |
| |
| Without Neuropsychological Sequelae | Post-COVID-19 symptomatic patients Without neuropsychological sequelae |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuropsychological Sequelae | Other | Neuropsychological Sequelae after SARS-CoV-2 symtomatic infection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of fatigue in patients with post-COVID-19 depression and/or anxiety | 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
| 6-9 months |
| Prevalence of fatigue in patients with post-COVID-19 post-traumatic stress disorder | 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 | 6-9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of post-COVID-19 fatigue in quality of life. | Fatigue will be assessed with the Chalder fatigue scale (binary score and global score). Quality of live will be assessed by the original EQ-5D questionnaire, that comprises two parts: - EQ-5D-3L, health state classification scheme of five items (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each having three alternatives (1= no problems, 2= moderate problems, and 3= severe problems). Calculating a single index score combines these five dimensions. The index value of a particular health state thus indicates the preference for being in that health state in relation to death, which has been set equal to 0 and best possible health (eg, no problems on any of the five items) which has been set to 1.0. - EQ VAS, a visual analog scale to health state ranging from 0 (worst possible health state) to 100 (best possible health state). |
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Inclusion Criteria:
Exclusion Criteria:
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The study will be conducted in five Portuguese Hospitals, Universitary and district, in which a follow-up post-COVID-19 medical consultation has been implemented
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ligia Pires, MD | Contact | +351282450300 | 43168 | alves1029@hotmail.com |
| Inês Simões, MD | Contact | +351282450300 | 43066 | inesgsimoes@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ligia Pires, MD | Centro Hospitalar Universitario do Algarve | Study Chair |
| Joana Berger, PHD | Universitat Bern | Study Director |
| Ligia Pires, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Particular de Alvor | Recruiting | Alvor | 8500-322 | Portugal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23748906 | Background | Ferreira LN, Ferreira PL, Pereira LN, Oppe M. The valuation of the EQ-5D in Portugal. Qual Life Res. 2014 Mar;23(2):413-23. doi: 10.1007/s11136-013-0448-z. Epub 2013 Jun 8. | |
| 25559796 | Background | Jackson C. The Chalder Fatigue Scale (CFQ 11). Occup Med (Lond). 2015 Jan;65(1):86. doi: 10.1093/occmed/kqu168. No abstract available. |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D005222 | Mental Fatigue |
| D000086382 | COVID-19 |
| D015673 | Fatigue Syndrome, Chronic |
| D005221 | Fatigue |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 6-9 months |
| Impact of post-COVID-19 neuropsychological sequelae in quality of life | Evaluate if the positive cases for anxiety, depression and/or PTSD have lower quality of live (The tools will be the same of previous outcomes). | 6-9 months |
| Evaluate if neuropsychological are associated with severity of acute COVID-19 | Depression and anxiety will be assessed with the Hospital Anxiety and Depression Scale
Posttraumatic Stress Symptoms-14 instrument, adapted in this protocol for COVID-19 survivors: - PTSS 14 scoring > 45 points Acute COVID-19 severity will be categorized as mild illness (mild symptoms without the radiographic appearance of pneumonia), pneumonia (having symptoms and the radiographic evidence of pneumonia, with no requirement for supplemental oxygen), severe pneumonia (having pneumonia, including one of the following: respiratory rate > 30 breaths/minute; severe respiratory distress; or SpO2 ≤ 93% on room air at rest), and critical cases (e.g. respiratory failure requiring mechanical ventilation or nasal high flow oxygen, septic shock, other organ failure occurrence or admission into the ICU). | 6-9 months |
| Centro Hospitalar Universitario do Algarve |
| Principal Investigator |
| Marta Drummond, PHD | Universidade do Porto | Principal Investigator |
| Hospital Professor Doutor Fernando Fonseca (Hff) | Completed | Amadora | 2720-276 | Portugal |
| Hospital de Faro (Chua) | Completed | Faro | 8000-386 | Portugal |
| Hospital de Portimao | Recruiting | Portimão | 8500-338 | Portugal |
|
| Hospital de Sao Sebastiao (Chedv) | Recruiting | Santa Maria da Feira | 4520-211 | Portugal |
|
| Hospital de Vila Franca de Xira (Hvfx) | Suspended | Vila Franca de Xira | 2600-009 | Portugal |
| 8463991 | Background | Chalder T, Berelowitz G, Pawlikowska T, Watts L, Wessely S, Wright D, Wallace EP. Development of a fatigue scale. J Psychosom Res. 1993;37(2):147-53. doi: 10.1016/0022-3999(93)90081-p. |
| 30285773 | Background | Rasa S, Nora-Krukle Z, Henning N, Eliassen E, Shikova E, Harrer T, Scheibenbogen C, Murovska M, Prusty BK; European Network on ME/CFS (EUROMENE). Chronic viral infections in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). J Transl Med. 2018 Oct 1;16(1):268. doi: 10.1186/s12967-018-1644-y. |
| 33528827 | Result | Simani L, Ramezani M, Darazam IA, Sagharichi M, Aalipour MA, Ghorbani F, Pakdaman H. Prevalence and correlates of chronic fatigue syndrome and post-traumatic stress disorder after the outbreak of the COVID-19. J Neurovirol. 2021 Feb;27(1):154-159. doi: 10.1007/s13365-021-00949-1. Epub 2021 Feb 2. |
| 32738287 | Result | Mazza MG, De Lorenzo R, Conte C, Poletti S, Vai B, Bollettini I, Melloni EMT, Furlan R, Ciceri F, Rovere-Querini P; COVID-19 BioB Outpatient Clinic Study group; Benedetti F. Anxiety and depression in COVID-19 survivors: Role of inflammatory and clinical predictors. Brain Behav Immun. 2020 Oct;89:594-600. doi: 10.1016/j.bbi.2020.07.037. Epub 2020 Jul 30. |
| 38241071 | Derived | Pires L, Reis C, Mesquita Facao AR, Moniri A, Marreiros A, Drummond M, Berger-Estilita J. Fatigue and Mental Illness Symptoms in Long COVID: Protocol for a Prospective Cohort Multicenter Observational Study. JMIR Res Protoc. 2024 Jan 19;13:e51820. doi: 10.2196/51820. |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D004679 | Encephalomyelitis |
| D000090862 | Neuroinflammatory Diseases |
| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |