French Cohort of COVID-19 Patients With Post-intensive Care Syndrome

Covid19 Clinical Trial

— COREADOM  

Official title:

French Cohort of covid19 Patients With Post-intensive Care Syndrome : Rehabilitation From Intensive Care Unit to Home Return - Spatio-temporal Analysis of Walking Compared to Asymptomatic Participants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04590170
• Other study ID #: APHP200812
• Status: Recruiting
• Start date: October 30, 2020
• Est. completion date: April 30, 2024

Study information

• Verified date: November 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Marie-Martine Lefevre-Colau, MD, PhD
• Phone: +33630480893
• Email: marie-martine.lefevre-colau[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to describe post-intensive care syndrome (PICS) of patients surviving to coronavirus disease 2019 (COVID19) and their rehabilitation and recovery process from hospital to home return

Description:

The novel coronavirus, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causing the COVID-19 emerged in December 2019 and was declared pandemic in March 2020.

Although the majority of reported COVID-19 cases are mild, approximatively 5% of patients require a stay in intensive care unit, with mechanical ventilation.

Post intensive care syndrome (PICS) consists of physical, cognitive and psychological dysfunctions.

Little is known about the rate and clinical presentations of PCIS among patients surviving to COVID-19.

The objective of this study is to describe the clinical manifestations of PCIS in COVID-19 patients, and their rehabilitation process until home return.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 30, 2024
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria - patients with covid19 infection :

• COVID 19 infection (PCR or CT-scan)

• ICU stay requiring mechanical ventilation

• Age =18 years old

Inclusion Criteria - control group :

• Age = 18 years old

• Able to walk without technical assistance,

• Having no orthopedic or neurological disorder likely to disturb balance and walking

• Have not had a severe form of Covid 19 disease in the last 12 months

• Collection of non-opposition

Exclusion Criteria:

• Inability to give consent

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Behavioral:
• Post-intensive Care unit syndrome
Post-intensive Care unit syndrome after an intensive care unit stay for the COVID19

Other:
• Spatiotemporal measurements of walking
Spatiotemporal measurements of walking in asymptomatic participants from the general population.

Locations

Country	Name	City	State
France	Department of Physical Medicine and Rehabilitation	Issy-les-Moulineaux
France	Department of Rehabilitation, Institute of Rheumatology Cochin	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	Change on cognitive Impairment: Vigilance (RASS)	Used to measure the agitation or sedation level of a person. Range -5 to +4 - Patients group	Between 10 days and 1 month after ICU's discharge
Primary	Change on cognitive Impairment: Cooperation	Yes/no - Patients group	Between 10 days and 1 month after ICU's discharge
Primary	Change on cognitive Impairment: Communication	Yes/no - Patients group	Between 10 days and 1 month after ICU's discharge
Primary	Change on cognitive Impairment: Agitation	Yes/no - Patients group	Between 10 days and 1 month after ICU's discharge
Primary	Change on cognitive Impairment: Delirium	Yes/no - Patients group	Between 10 days and 1 month after ICU's discharge
Primary	Change on cognitive Impairment : Introduction of neuroleptic	Yes/no - Patients group	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Primary	Change on cognitive Impairment: temporo-spatial disorientation	Yes/no - Patients group	Between 10 days and 1 month after ICU's discharge
Primary	Change on physical Impairment : dyspnea	Yes/No - Patients group	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Primary	Change on physical Impairment: Modified Borg scale dyspnea score.	Verbal and numerical scale that asks you to rate the difficulty of your breathing Patients are asked to tick the boxes that reflect their dyspnea perception best range 0-10 lesser is better - Patients group	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Primary	Change on physical Impairment : cough	Yes/No - Patients group	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Primary	Change on physical Impairment : respiratory rate	Number of breaths/per minute. - Patients group	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Primary	Change on physical Impairment : ventilation mode	Tracheotomy/ ambient air / OXYGEN THERAPY Other - Patients group	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Primary	Change on physical Impairment : Peripheral capillary oxygen saturation (SpO2) at rest	measured by pulse oximetry, which provides an indirect measurement of arterial oxygenation (SaO2) based on the differential absorption of light by oxygenated and deoxygenated blood during pulsatile blood flow - Patients group	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Primary	Change on physical Impairment : respiratory rate on activity	respiratory rate breathing rate on activity - Patients group	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Primary	Change on physical Impairment : Peripheral capillary oxygen saturation (SpO2) on activity	measured by pulse oximetry, which provides an indirect measurement of arterial oxygenation (SaO2) based on the differential absorption of light by oxygenated and deoxygenated blood during pulsatile blood flow during activity - Patients group	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Primary	Change on physical Impairment : orthostatic hypotension	Yes/no drop in blood pressure that occurs when moving from a laying down (supine) position to a standing (upright) position. - Patients group	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Primary	Change on physical Impairment : electrocardiogram at rest	electrocardiogram at rest - Patients group	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Primary	Change on physical impairment : numeric verbal scales of fatigue	self-evaluation numeric verbal scales of fatigue - Patients group ranges (0-10) lesser is better	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Primary	Change on physical Impairment: numeric verbal scales of pain	self-evaluation numeric verbal scales of pain ranges (0-10) lesser is better	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Primary	Change on physical Impairment : stiffness or pain involving joints	Yes/No small joints (wrists, fingers, toes) and large joints (shoulders, elbows, hips, knees, ankles); Patients group	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Primary	Change on physical Impairment : stability of the trunk in siting	Yes/no - Patients group	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Primary	Change on physical Impairment : autonomy for bed-chair transfers	Yes/no - Patients group	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Primary	Change on physical Impairment autonomy for walking	Yes/no - Patients group	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Primary	Change on physical Impairment : sores	Yes/no Localisation; Patients group	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Primary	Change on Imagery cerebral	date and result if applicable - Patients group	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Primary	Change on physical Impairment neurologic exam	motor or sensory deficits involving the upper and the lower limbs (yes/no) Anosmia Yes/no taste loss Yes/no; Patients group	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Primary	Change on physical Impairment Medical Research Council (MRC-SS MRC Sum score)	assess muscle strength from Grade 5 (normal) to Grade 0 (no visible contraction).; MRC-SS score was defined as the sum of MRC scores from six muscles in the upper and lower limbs on both sides so that the score ranged from 60 (normal) to 0 (quadriplegic).; Patients group	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Primary	Change on physical Impairment five times sit to stand test	The score is the amount of time (to the nearest decimal in seconds) it takes a patient to transfer from a seated to a standing position and back to sitting five times without use of arms, Equipment • Standard height chair (43-45 cm, 17-18 inches) with a backrest. If the patient cannot perform five stands to complete the test without use of arms, a score of 0 seconds should be documented.; Patients group	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Primary	Change on cognitive Impairment The Montreal Cognitive Assessment (MoCA)	Designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstruction skills, conceptual thinking, calculations, and orientation. Range 0 -30 higher is better; Patients group	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Primary	Cognitive Impairment Frontal Assessment Battery (FAB)	Total score is from a maximum of 18, higher scores indicating better performance.; Patients group	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Primary	Change on psychological Impairment : sadness	Yes/no - Patients group	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Primary	Change on psychological Impairment : anxiety	Yes/no - Patients group	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Primary	Change on psychological Impairment: Insomnia	Yes/no - Patients group	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Primary	Change on psychological Impairment : Apathy	Yes/no - Patients group	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Primary	Change on psychological Impairment : sideration	Yes/no - Patients group	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Primary	Change on psychological Impairment : Despair	Yes/no - Patients group	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Primary	Change on psychological Impairment : Culpability	Yes/no - Patients group	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Primary	Change on psychological Impairment : Conduit addictive	Yes/no - Patients group	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Primary	Change on psychological Impairment : psychiatric or psychologic care	Yes/no - Patients group	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Primary	assess type of psychiatric treatment	Type - Patients group	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Primary	Change on psychological Impairment : Hospital Anxiety and Depression Scale (HADS)	A 14-item self-report screening scale that was originally developed to indicate the possible presence of anxiety and depressive states It contains two 7-item scales: one for anxiety and one for depression both with a score range of 0-21.; Patients group	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Primary	Change on psychological Impairment : Posttraumatic Stress Disorder Checklist Scale (PCL-S)	20-item questionnaire, corresponding to the Manual of Mental Disorders (DSM-5) symptom criteria for PTSD.; Patients group	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Primary	assess psychological Impairment	Introduction of antidepressant drugs Type; Patients group	Change between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Primary	assess psychological Impairment	Introduction of neuroleptic Type; Patients group	change between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Secondary	asses demographics information	Age, sex, formal education, marital status, occupation, place of living, socio-professional category; Patients group	Between 10 days and 1 month after ICU's discharge
Secondary	assess comorbidities	number of comorbidities; Patients group	Between 10 days and 1 month after ICU's discharge
Secondary	assess past and current medications	Precise; Patients group	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Secondary	assess related symptoms nature of COVID-19	duration of COVID-19-related symptoms nature Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay and/or CT-scan showing typical radiological findings; Patients group	Between 10 days and 1 month after ICU's discharge
Secondary	assess characteristics of ongoing hospitalization	number of characteristics of ongoing hospitalization (invasive ventilation, curare, others treatments ); Patients group	Between 10 days and 1 month after ICU's discharge
Secondary	assess medical complications in intensive care	Pneumopathy pulmonary embolism others; Patients group	Between 10 days and 1 month after ICU's discharge
Secondary	Descriptive data of the rehabilitation care pathway after stay in intensive care until return home	Number of days to discharge from hospital Service of rehabilitation care hospital at home (HAH) return at home; Patients group	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Secondary	Number of new medical qualifying events since last contact	complications; Patients group	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Secondary	Social status	professional activity unemployment retirement others; Patients group	Between 10 days and 1 month and 3 months and 6 months after ICU's discharge
Secondary	Activities of Daily Living (ADL) scale	Related to personal care (self-performance) looks at four of these tasks: transfer, bed mobility, toileting and eating. The resident's self- performance and the amount of staff support provided are evaluated for all of these tasks ranges from 0 (independent) to 4 (total dependence); Patients group	3 months and 6 months after ICU's discharge
Secondary	Quality of life Medical outcome study short form 12 items (MOS-SF-12 ) questionnaire	Self-reported outcome measure assessing the impact of health on an individual's everyday life Patients fill out a 12-question survey which is then scored by a clinician or researcher.; Questionnaire consisting of 12 questions that measure 8 health domains to assess physical and mental health. Physical health-related domains include General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP). Mental health-related scales include Vitality (VT), Social Functioning (SF), Role Emotional (RE), and Mental Health (MH).; Patients group	3 months and 6 months after ICU's discharge
Secondary	Gait analysis 6-minute walk test (6MWT)	Sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.; Patients group	3 months and 6 months after ICU's discharge
Secondary	Balance and Gait analysis	Inertial Sensors to Assess Gait Quality; Patients group	3 months and 6 months after ICU's discharge
Secondary	Spatio-temporal parameters of walking	Comparison of spatio-temporal measures of walking in patients with severe Covid 19 infection to those of an age- and sex-matched sample of asymptomatic participants.; Both groups	Inclusion