Cochin Hospital
Paris, 75014, France
NCT Number: NCT04724395
The purpose of the study is to describe disability following hospitalization in people of working-age surviving COVID-19.
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Notify Me18 year–70 year
All sexes
Observational
Paris, 75014, France
In December 2019, the Wuhan Municipal Health Committee in China identified an outbreak with viral pneumonia cases of unknown cause. Coronavirus RNA was identified as the causal agent. The disease caused by SARS-CoV-2 has been named COVID-19. While most people with COVID-19 develop uncomplicated illness, approximately 14% develop severe forms of the disease and 5% are critically ill, potentially leaving survivors with non-fatal sequelae. To date, the long-term burden of COVID-19 and patients' perspectives and needs have been left unaddressed. As compared to 2003 SARS outbreak, one can anticipate persisting disability in COVID-19 survivors, including specific post-COVID and non-specific post-intensive care syndromes. The investigators hypothesize that dramatic COVID-19-specific and non-specific mid- and long-term disabilities would persist in people surviving COVID-19.
The main objective will be to provide a deep understanding of non-fatal health outcomes in people surviving COVID-19, by comprehensively and systematically mapping and monitoring, within the WHO ICF framework, disability levels and profiles, in the mid and long terms in people surviving COVID-19.
Disability levels will be assessed at 12 (±7) and 36 (±3) months using:
A. The secondary objectives will be to describe COVID-19 specific and non-specific impairments, activity limitations and participation restriction at 12 (±7) and 36 (±3) months in people surviving COVID-19:
B. Another secondary objective will be to assess the burden of the patient's SARS-CoV-2 infection on the patient's close relative, between M12-inclusion and M36 patient visits.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Hospitalization in intensive care and non-intensive care units for COVID-19 followed by usual care
Time frame: At 12 (±7) months after hospitalization
Disability levels will be assessed using Part 1a (impairments of body functions) and 2 (activity limitation and participation restriction) of the WHO ICF checklist v2.1, administered by a health care provider.
Time frame: 36 (±3) months after hospitalization
Disability levels will be assessed using Part 1a (impairments of body functions) and 2 (activity limitation and participation restriction) of the WHO ICF checklist v2.1, administered by a health care provider
Time frame: At 12 (±7) months after hospitalization
Disability levels will be assessed using the self-administered 36-item WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time frame: 36 (±3) months after hospitalization
Disability levels will be assessed using the self-administered 36-item WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time frame: At 12 (±7) and 36 (±3) months after hospitalization
Non-pharmacological / pharmacological treatments will be self-reported : ER consultations, specialist consultations, laboratory tests, new hospital stay, rehabilitation resource consumption
Time frame: 12(±7) and 36 (±3) months after the first day of the first hospitalization.
Anchor questions ( 2 questions)
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
EuroQol : ED-5D-5L (5 themes of questions + a scale from 0 to 100, 100 is the best state of health)
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Brief Pain Inventory (7 scales from 0 to 10 : 10 is the worst pain)
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Modified Fatigue Impact Scale (8 questions)
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Hospital Anxiety and Depression Scale (14 questions with scales from 0 to 3)
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Post-Traumatic Stress Disorder Checklist Scale (17 questions with a scale from 1 to 5)
Time frame: 12 (±7), and 36 (±3) months after the first day of the first hospitalization.
Brain Injury Complaint Questionnaire (25 questions)
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Urinary Symptom Profile (10 questions)
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Female Sexual Function Index
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
International Index of Erectile Function (5 questions with a scale from 0 to 5)
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
36-Item WHODAS 2.0
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Work Ability Index Single-Item 1 (1 question with a scale from 0 to 10, 10 is the highest ability to work)
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Work Productivity and Activity Impairment questionnaire Single-Item 5 (1 question with a scale from 0 to 10, 10 is the worst productivity)
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Charlson comorbidity index (20 items)
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
WHO ICF checklist v2.1
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
6 minute walk test
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Timed up and go test
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Box and Block test
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
MRC Dyspnoea scale
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
NYHA grade
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Montreal Cognitive Assessment
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Frontal Assessment Battery
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
MRC-Sum Score
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Sustained Expiration while counting
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Grip strength
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization.
Chair rise with arms
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization
Time frame: 12 (±7) and 36 (±3) months after the first day of the first hospitalization
Time frame: Between 12 (±7) and 36 (±3) months after the first day of the first hospitalization of the patient.
Zarit Burden Inventory (22 questions with a scale from 0 to 4) (using printed version of specific self-administered questionnaires completed by the patient' close relative)
Time frame: Between 12 (±7) and 36 (±3) months after the first day of the first hospitalization of the patient.
Resource Utilization in Dementia - Part I (3 items of questions) (using printed version of specific self-administered questionnaires completed by the patient' close relative)
Time frame: Between 12 (±3) and 36 (±3) months after the first day of the first hospitalization of the patient.
Hospital Anxiety and Depression Scale (using printed version of specific self-administered questionnaires completed by the patient' close relative)
Time frame: Between 12 (±7) and 36 (±3) months after the first day of the first hospitalization of the patient.
Post-Traumatic Stress Disorder Check-list Scale (using printed version of specific self-administered questionnaires completed by the patient' close relative)
Assistance Publique - Hôpitaux de Paris
Other
Prospective Multicenter Cohort Study to Evaluate Disability Following Hospitalization in People of Working-age Surviving COVID-19
Acronym: DisCOVID
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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