Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2022-04-01
2023-04-30
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Neuropsychological Sequelae
Post-COVID-19 symptomatic patients with neuropsychological sequelae
Neuropsychological Sequelae
Neuropsychological Sequelae after SARS-CoV-2 symtomatic infection
Without Neuropsychological Sequelae
Post-COVID-19 symptomatic patients Without neuropsychological sequelae
No interventions assigned to this group
Interventions
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Neuropsychological Sequelae
Neuropsychological Sequelae after SARS-CoV-2 symtomatic infection
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
95 Years
ALL
No
Sponsors
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Universidade do Algarve
OTHER
Universidade do Porto
OTHER
Centro Hospitalar Universitario do Algarve
OTHER
Responsible Party
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Ligia Pires
Principal Investigator
Principal Investigators
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Ligia Pires, MD
Role: STUDY_CHAIR
Centro Hospitalar Universitario do Algarve
Joana Berger, PHD
Role: STUDY_DIRECTOR
Universitat Bern
Ligia Pires, MD
Role: PRINCIPAL_INVESTIGATOR
Centro Hospitalar Universitario do Algarve
Marta Drummond, PHD
Role: PRINCIPAL_INVESTIGATOR
Universidade do Porto
Locations
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Hospital Particular de Alvor
Alvor, , Portugal
Hospital Professor Doutor Fernando Fonseca (Hff)
Amadora, , Portugal
Hospital de Faro (Chua)
Faro, , Portugal
Hospital de Portimao
Portimão, , Portugal
Hospital de Sao Sebastiao (Chedv)
Santa Maria da Feira, , Portugal
Hospital de Vila Franca de Xira (Hvfx)
Vila Franca de Xira, , Portugal
Countries
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Central Contacts
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Facility Contacts
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Ligia Pires, MD
Role: backup
References
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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.
Jackson C. The Chalder Fatigue Scale (CFQ 11). Occup Med (Lond). 2015 Jan;65(1):86. doi: 10.1093/occmed/kqu168. No abstract available.
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.
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.
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.
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.
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.
Other Identifiers
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141/21
Identifier Type: -
Identifier Source: org_study_id
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