Disability Following Hospitalization in People of Working-age Surviving SARS-CoV-2 Infection - COVID-19

COVID-19 Clinical Trial

— DisCOVID  

Official title:

Prospective Multicenter Cohort Study to Evaluate Disability Following Hospitalization in People of Working-age Surviving COVID-19

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04724395
• Other study ID #: P200601
• Secondary ID: 2020-A02552-37
• Status: Recruiting
• Start date: March 31, 2021
• Est. completion date: September 2025

Study information

• Verified date: September 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Christelle NGUYEN, MD, PhD
• Phone: +33 1 58 41 29 45
• Email: christelle.nguyen2[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to describe disability following hospitalization in people of working-age surviving COVID-19.

Description:

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:

• Parts 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, and

• Self-administered 36-item WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)

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:

• Impairments, participation restrictions and health-related quality of life (HRQoL) at 12 (±7) and 36 (±3) months will be assessed using online specific self-administered questionnaires and face-to-face specific tests

• Non-pharmacological / pharmacological treatments at baseline, 12 (±7) and 36 (±3) months will be self-reported

• Total costs, cost drivers and estimated Years-Lived with Disability (YLDs) at 36 (±3) months will be calculated 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

• The burden on patient's close relative will be assessed using specific printed self-administered questionnaires

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: September 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Adults of working-age (18 to 70 years),

• Hospitalization during the prespecified inclusion period (from March 2020 to March 2021) (NB : in case of transferred patients, inclusion in the DisCOVID study must be carried out in the first place of admission for COVID),

• Laboratory-confirmed SARS-CoV-2 and/or CT-scan showing typical radiological findings,

• SARS-CoV-2 of any duration,

• Ability to comply with study visits,

• Informed written consent

Exclusion Criteria:

• Return home in less than 72 hours

• Absence of health insurance,

• Inability to fluently speak and/or read French language,

• People under tutorship or curatorship and protected adults.

Related Conditions & MeSH terms

• COVID-19

Intervention

Other:
• Hospitalization
Hospitalization in intensive care and non-intensive care units for COVID-19 followed by usual care

Locations

Country	Name	City	State
France	Cochin Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-acute COVID-19 disability from the care provider's perspective, 12 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	At 12 (±3) months after hospitalization
Primary	Post-acute COVID-19 disability from the care provider's perspective, 36 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	36 (±3) months after hospitalization
Primary	Post-acute COVID-19 disability from the patient's perspectives, 12 months after hospitalization	Disability levels will be assessed using the self-administered 36-item WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)	At 12 (±3) months after hospitalization
Primary	Post-acute COVID-19 disability from the patient's perspectives, 36 months after hospitalization	Disability levels will be assessed using the self-administered 36-item WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)	36 (±3) months after hospitalization
Secondary	Type of treatments	Non-pharmacological / pharmacological treatments will be self-reported : ER consultations, specialist consultations, laboratory tests, new hospital stay, rehabilitation resource consumption	At 12 (±3) and 36 (±3) months after hospitalization
Secondary	Acceptable symptom state (questionnaire self-administered on ComPARe IT dedicated platform)	Anchor questions ( 2 questions)	12(±3) and 36 (±3) months after the first day of the first hospitalization.
Secondary	Health-related quality of life (questionnaire self-administered on ComPARe IT dedicated platform)	EuroQol : ED-5D-5L (5 themes of questions + a scale from 0 to 100, 100 is the best state of health)	12 (±3) and 36 (±3) months after the first day of the first hospitalization.
Secondary	Pain (questionnaire self-administered on ComPARe IT dedicated platform)	Brief Pain Inventory (7 scales from 0 to 10 : 10 is the worst pain)	12 (±3) and 36 (±3) months after the first day of the first hospitalization.
Secondary	Impairments, activity limitations and participation restrictions, health-related quality of life Fatigue (questionnaire self-administered on ComPARe IT dedicated platform)	Modified Fatigue Impact Scale (8 questions)	12 (±3) and 36 (±3) months after the first day of the first hospitalization.
Secondary	Impairments, activity limitations and participation restrictions, health-related quality of life (questionnaires self-administered on ComPARe IT dedicated platform)	Hospital Anxiety and Depression Scale (14 questions with scales from 0 to 3)	12 (±3) and 36 (±3) months after the first day of the first hospitalization.
Secondary	Impairments, activity limitations and participation restrictions, health-related quality of life (questionnaires self-administered on ComPARe IT dedicated platform)	Post-Traumatic Stress Disorder Checklist Scale (17 questions with a scale from 1 to 5)	12 (±3) and 36 (±3) months after the first day of the first hospitalization.
Secondary	Impairments, activity limitations and participation restrictions, health-related quality of life (questionnaires self-administered on ComPARe IT dedicated platform)	Brain Injury Complaint Questionnaire (25 questions)	12 (±3), and 36 (±3) months after the first day of the first hospitalization.
Secondary	Urinary symptoms, if applicable (questionnaire self-administered on ComPARe IT dedicated platform)	Urinary Symptom Profile (10 questions)	12 (±3) and 36 (±3) months after the first day of the first hospitalization.
Secondary	Female sexual dysfunction, if applicable (questionnaire self-administered on ComPARe IT dedicated platform)	Female Sexual Function Index	12 (±3) and 36 (±3) months after the first day of the first hospitalization.
Secondary	Erectile dysfunction, if applicable (questionnaire self-administered on ComPARe IT dedicated platform)	International Index of Erectile Function (5 questions with a scale from 0 to 5)	12 (±3) and 36 (±3) months after the first day of the first hospitalization.
Secondary	Global activity limitations and participation restrictions (questionnaire self-administered on ComPARe IT dedicated platform)	36-Item WHODAS 2.0	12 (±3) and 36 (±3) months after the first day of the first hospitalization.
Secondary	Work Ability (questionnaire self-administered on ComPARe IT dedicated platform)	Work Ability Index Single-Item 1 (1 question with a scale from 0 to 10, 10 is the highest ability to work)	12 (±3) and 36 (±3) months after the first day of the first hospitalization.
Secondary	Work productivity (questionnaire self-administered on ComPARe IT dedicated platform)	Work Productivity and Activity Impairment questionnaire Single-Item 5 (1 question with a scale from 0 to 10, 10 is the worst productivity)	12 (±3) and 36 (±3) months after the first day of the first hospitalization.
Secondary	Comorbidities (score completed by the investigator during a face-to-face visit)	Charlson comorbidity index (20 items)	12 (±3) and 36 (±3) months after the first day of the first hospitalization.
Secondary	Impairments, activity limitations and participation restrictions (checklist completed by the investigator during a face-to-face visit)	WHO ICF checklist v2.1	12 (±3) and 36 (±3) months after the first day of the first hospitalization.
Secondary	Mobility test to assess the consequences of neurological, cardiorespiratory, osteoarticular or respiratory impairments (clinical assessment by the investigator during a face-to-face visit)	6 minute walk test	12 (±3) and 36 (±3) months after the first day of the first hospitalization.
Secondary	Locomotor impairments (clinical assessment by the investigator during a face-to-face visit)	Timed up and go test	12 (±3) and 36 (±3) months after the first day of the first hospitalization.
Secondary	Upper extremities impairments (clinical assessment by the investigator during a face-to-face visit)	Box and Block test	12 (±3) and 36 (±3) months after the first day of the first hospitalization.
Secondary	Respiratory impairment (clinical assessment by the investigator during a face-to-face visit)	MRC Dyspnoea scale	12 (±3) and 36 (±3) months after the first day of the first hospitalization.
Secondary	Respiratory impairment (clinical assessment by the investigator during a face-to-face visit)	NYHA grade	12 (±3) and 36 (±3) months after the first day of the first hospitalization.
Secondary	Cognitive impairments (clinical assessment by the investigator during a face-to-face visit)	Montreal Cognitive Assessment	12 (±3) and 36 (±3) months after the first day of the first hospitalization.
Secondary	Cognitive impairments (clinical assessment by the investigator during a face-to-face visit)	Frontal Assessment Battery	12 (±3) and 36 (±3) months after the first day of the first hospitalization.
Secondary	Muscular impairments (clinical assessment by the investigator during a face-to-face visit)	MRC-Sum Score	12 (±3) and 36 (±3) months after the first day of the first hospitalization.
Secondary	Respiratory impairments (clinical assessment by the investigator during a face-to-face visit)	Sustained Expiration while counting	12 (±3) and 36 (±3) months after the first day of the first hospitalization.
Secondary	Muscular impairments (clinical assessment by the investigator during a face-to-face visit)	Grip strength	12 (±3) and 36 (±3) months after the first day of the first hospitalization.
Secondary	Muscular impairments (clinical assessment by the investigator during a face-to-face visit)	Chair rise with arms	12 (±3) and 36 (±3) months after the first day of the first hospitalization.
Secondary	Total costs		36 months after the first day of the first hospitalization.
Secondary	Costs drivers	Total costs, cost ivers and estimated Years-Lived with Disability (YLDs)	36 months after the first day of the first hospitalization.
Secondary	Estimated Years lived with Disability		36 months after the first day of the first hospitalization.
Secondary	Burden of post-acute COVID-19 on participant's close relative	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)	Between 12 (±3) and 36 (±3) months after the first day of the first hospitalization of the patient.
Secondary	Resource utilization	Resource Utilization in Dementia - Part I (3 items of questions) (using printed version of specific self-administered questionnaires completed by the patient' close relative)	Between 12 (±3) and 36 (±3) months after the first day of the first hospitalization of the patient.
Secondary	Symptoms of anxiety and/or depression of participant's close relative	Hospital Anxiety and Depression Scale (using printed version of specific self-administered questionnaires completed by the patient' close relative)	Between 12 (±3) and 36 (±3) months after the first day of the first hospitalization of the patient.
Secondary	Symptoms of post-traumatic stress	Post-Traumatic Stress Disorder Check-list Scale (using printed version of specific self-administered questionnaires completed by the patient' close relative)	Between 12 (±3) and 36 (±3) months after the first day of the first hospitalization of the patient.