Long-term Neurocognitive and Psychiatric Consequences in Severe COVID-19 Survivors. (NPQCOVID)
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|ClinicalTrials.gov Identifier: NCT05019300|
Recruitment Status : Recruiting
First Posted : August 24, 2021
Last Update Posted : August 31, 2021
|Condition or disease||Intervention/treatment|
|Covid19 Neurocognitive Dysfunction||Biological: Exposure: COVID-19 severity|
|Study Type :||Observational|
|Estimated Enrollment :||80 participants|
|Official Title:||Long-term Neurocognitive and Psychiatric Consequences of COVID-19 in Patients Discharged From Critical Care Units. A Cohort Study of the Advance Interdisciplinary Rehabilitation Register (AIRR) Covid-19 Working Group.|
|Actual Study Start Date :||May 24, 2021|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||October 2021|
COVID-19 patients discharged from critical care units
Adults over 18 years of age who have been hospitalized after COVID-19 diagnosis in the critical care units of Red Salud UC Christus who have been cognitively evaluated with Montreal Cognitive Assessment (MoCA) days prior to their discharge. All patients with a previous history of confirmed neurocognitive or psychotic disorders, prior to hospital admission, were excluded.
Biological: Exposure: COVID-19 severity
COVID-19 severity between 4 to 7 points according the seven-category scale of clinical status reported by Huang et al. (2021) and severe to critical symptomatic levels on spectrum of disease reported by Wu and McGoogan (2020).
- Cognitive impairment screening [ Time Frame: 12 months ]
Montreal Cognitive Assessment (MoCA®). Evaluation of cognitive domains (visuospatial, executive function; attention and memory; orientation; language).
Min score: 0 Max score: 30 Cut-off for chilean population: < 21 for mild cognitive impairment. < 20 for dementia
Setting: Home and online
- Cognitive performance [ Time Frame: 12 months ]
Cambridge Neuropsychological Test Automated Battery (CANTAB®)
Reaction time test, (RTI) Paired associate learning (PAL) Spatial Working Memory (SWM) Spatial Span (SSP) Rapid Visual Information Processing (RVP) Cambridge Gambling Task (CGT) Intra/Extra Dimensional Set Shift (IED) Stockings of Cambridge (SOC)
Scores: z-scores normalized by sex and educational level
- Neurological Soft Signs [ Time Frame: 12 months ]
Test: Heidelberg Neurological Soft Signs Scale
16 items on five factors ("motor coordination": Ozeretzki's test, diadochokinesis, pronation/supination, finger-to-thumb opposition, speech and articulation; "sensory integration": gait, tandem walking, two-point discrimination; "complex motor tasks": finger-to-nose test, fist-edge-palm test; "right/left and spatial orientation": right/left orientation, graphesthesia, face-hand test, stereognosis; "hard signs": arm holding test, mirror movements). All items except for gait, tandem gait, Ozeretzki's test, speech and articulation and right/left orientation are assessed separately for both, right and left sites respectively. Ratings are given on a 0-3 point scale (no/slight/moderate/marked abnormality).
Higher scores mean worse outcomes. Min score: 0 Max score: 48 No cut-off point established in the literature.
- Anxiety [ Time Frame: 12 months ]
Test: Generalized Anxiety Disorder-7 score
The seven items assess (1) feeling nervous, anxious, or on edge; (2) being able to stop or control worrying; (3) worrying too much about different things; (4) trouble relaxing; (5) being restless; (6) becoming easily annoyed or irritable; and (7) feeling afraid as if something awful might happen.
Increasing scores on the scale are strongly associated with multiple domains of functional impairment and increasing anxiety.
The cut-off point suggested is of ≥10 Min score: 0 Max score: 21
- Depressive syndrome [ Time Frame: 12 months ]
Test: Patient Health Questionary-2 (PHQ-2) score for screening of depressive syndrome
The cut-off point suggested is of ≥3 Min score: 0 Max score: 6
- Post Traumatic Stress Disorder [ Time Frame: 12 months ]
Test: Post Traumatic Checklist for Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5) score
20-item self-report measure that assesses the 20 DSM-5 symptoms of Post Traumatic Stress Disorder.
The cut-off point suggested is of ≥33 Min score: 0 Max score: 80
- Physical disability [ Time Frame: 12 months ]
Test: Barthel Index score
Measures physical disability behaviour relating to activities of daily living.
Scores of 0-20 indicate "total" dependency, 21-60 indicate "severe" dependency, 61-90 indicate "moderate" dependency, and 91-99 indicates "slight" dependency.
- Exercise endurance [ Time Frame: 12 months ]
Performance on 6 minutes- walk test
Evaluation of aerobic capacity and exercise endurance.
- Fatigue [ Time Frame: 12 months ]
Measured by the Modified fatigue impact scale (MFIS). The MFIS is a modified version of the 40-item Fatigue Impact Scale (FIS), which was originally developed to assess the effects of fatigue on quality of life in patients with chronic diseases. The FIS has patients rate the extent to which fatigue has affected their life in the past 4 weeks on a questionnaire consisting of 10 "physical" items, 10 "cognitive" items, and 20 "social" items, with 0 indicating "no problem" and 4 indicating "extreme problem."
The cut-off point suggested is of ≥38 Min score: 0 Max score: 160
- Global functionality [ Time Frame: 12 months ]
Post-Covid-19 functional scale 5 levels of severity, where o is non impairment and 5 is the highest level of impairment.
- Quality of life related to health [ Time Frame: 12 months ]
Test: The 5-level EuroQol 5D health questionnaire. (EQ-5D-5L) Self rated.
Min score: 0 Max score: 100 highest score means worst quality of life.
- Muscle strength [ Time Frame: 12 months ]Dynamometry Setting: Home
- Pain severity [ Time Frame: 12 months ]
Scale: Stanford pain scale
Min: 0 represents no pain Max: 10 represents unimaginable or unspeakable pain Setting: online
- Spontaneous Speech [ Time Frame: 12 months ]
Spontaneous Speech is a useful research tool to assess the scope of language disorders in people with neurological deficits. Short samples be analyzed during a brief interview and based of 10 linguistics parameters, it will characterized level and the type of language deficit. The 10 linguistic parameters are based on the ALEA method
Setting: Home and online
- Verbal fluency [ Time Frame: 12 months ]
Verbal fluency (phonological and sematic) will be assed by requesting the participants to elicit word under 1 minute for letter F, A and S and for the category animals.
Setting: Home and online
- complex post-traumatic stress disorder [ Time Frame: 12 months ]
Test: International Trauma Questionnaire self-report measure for post-traumatic stress disorder (PTSD) and complex post-traumatic stress disorder (CPTSD), corresponding to the diagnostic criteria in the International Classification of Diseases, 11th Revision (ICD-11).
- irritable bowel syndrome [ Time Frame: 12 months ]Rome IV criteria Setting: online
- Insomnia [ Time Frame: 12 months ]
Scale: Pittsburgh insomnia rating scale
Seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.
- Dysautonomia [ Time Frame: 12 months ]
Scales: Scales for outcomes in Parkinson's dysfunction-autonomic (SCOPA-AUT), Orthostatic hypotension symptom assessment (OHSA) and Orthostatic hypotension activity scale (OHACT).
- Dyspnea [ Time Frame: 12 months ]
Test: Chronic obstructive pulmonary disease (COPD) assessment test (CAT).
Min: 0 Max: 40 CAT ≥10 corresponds to either GOLD Group B or D. Group B patients' preferred treatment is to start either on LABA, or LAMA and if persistent symptoms then combination LAMA/LABA therapy-these are the minimum for patients with CAT Score ≥10.
CAT <10 corresponds to GOLD Group A or C. Group A patients' preferred treatment is to start bronchodilator (LABA or LAMA) and evaluate the effect.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05019300
|Contact: Constanza Caneo, MDemail@example.com|
|Contact: Carolina Mendez, PhD||+56 firstname.lastname@example.org|
|Centro de Investigaciones Médicas, Centro de Investigación Clínica UC, Hospital Clínico UC, San Carlos de Apoquindo, Departamento de Ciencias de la Salud, Escuela de Medicina, Red UC-Christus, Campus Clínico San JoaPontificia Universidad Catolica de Chile||Recruiting|
|Santiago, Chile, 8320000|
|Contact: Constanza Caneo, MD +56942909250 email@example.com|
|Contact: Carolina Mendez-Orellana, PhD +56 942595693 firstname.lastname@example.org|
|Sub-Investigator: Felipe Leon, MD|
|Sub-Investigator: Francisco Palacios, MD|
|Principal Investigator: Carolina Astudillo, PhD|
|Principal Investigator: Felix Bacigalupo, PhD|
|Principal Investigator: Claudia Gonzalez, PhD|
|Principal Investigator: Bernardita Soler, PhD|
|Principal Investigator: Jaime Godoy, MD|
|Principal Investigator: Sebastian Bravo, MD|
|Principal Investigator: Claudia Saez, MD|
|Principal Investigator: Luis Rojas, PhD|
|Study Director:||Rafael Medina, PhD||Pontificia Universidad Catolica de Chile|
|Study Director:||Arnoldo Riquelme, PhD||Pontificia Universidad Catolica de Chile|
|Principal Investigator:||Constanza Caneo, MD||Pontificia Universidad Catolica de Chile|
|Principal Investigator:||Carolina Mendez, PhD||Pontificia Universidad Catolica de Chile|