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

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

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

Study Overview

• Status: Recruiting
• Conditions: COVID-19
• Intervention / Treatment: Other: Hospitalization

Detailed 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

• Study Type: Observational
• Enrollment (Anticipated): 800

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Recruiting
    • Cochin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

People of working-age surviving COVID-19

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Total costs		36 months after the first day of the first hospitalization.
Costs drivers	Total costs, cost ivers and estimated Years-Lived with Disability (YLDs)	36 months after the first day of the first hospitalization.
Estimated Years lived with Disability		36 months after the first day of the first hospitalization.
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Study Director: Dominic PERENNOU, MD, PhD, Assistance Publique - Hôpitaux de Paris; Study Director: François RANNOU, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 31, 2021
• Primary Completion (ANTICIPATED): March 1, 2025
• Study Completion (ANTICIPATED): September 1, 2025

Study Registration Dates

• First Submitted: November 30, 2020
• First Submitted That Met QC Criteria: January 24, 2021
• First Posted (ACTUAL): January 26, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: COVID-19; Health-related quality of life; Disability; SARS-CoV-2 infection; Post-acute COVID-19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: P200601; 2020-A02552-37 (OTHER: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No