Rehabilitation After Admission in Intensive Care Unit for COVID-19

NCT04523051 | Completed

• 1 other identifier: 2020-05Obs-CHRMT
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 3

Brief Summary

France and especially the region "Grand Est" have been severely impacted by the COVID-19 pandemic. The first affected patients gradually began leaving the hospitalization sector and some of them required rehabilitation before returning home. Because it has only been studied for few months, COVID 19 possible impairment remain unknown, especially in patients who required admission in ICU and needed rehabilitation. In order to better understand the impact of the disease, the investigators wish to carry out a descriptive analysis of hospitalized patient in rehabilitation center for Post-Covid-19 rehabilitation after ICU. The purpose of this study was to describe the impairments and functional independency in patients addressed to a rehabilitation center after an ICU stay for COVID 19 and to explore the factors associated with their evolution.

Conditions

Covid19

Outcome Measures

Primary Outcomes (3)

• Functional Independence measure (FIM) at the admission

  The FIM is an 18-item clinician-reported scale that assesses function in six areas including self-care, continence, mobility, transfers, communication and cognition. Each of the 18 items is graded on a scale of 1-7 based on level of independence in that item (1=total assistance required, 7=complete independence).

  Day 1

• Functional Independence measure (FIM) 1-month hospitalization

  The FIM is an 18-item clinician-reported scale that assesses function in six areas including self-care, continence, mobility, transfers, communication and cognition. Each of the 18 items is graded on a scale of 1-7 based on level of independence in that item (1=total assistance required, 7=complete independence).

  Day 30

• Functional Independence measure (FIM) at the discharge

  The FIM is an 18-item clinician-reported scale that assesses function in six areas including self-care, continence, mobility, transfers, communication and cognition. Each of the 18 items is graded on a scale of 1-7 based on level of independence in that item (1=total assistance required, 7=complete independence).

  Day 180

Secondary Outcomes (27)

• weight at admission

  Day 1

• weight at the discharge

  Day 180

• age

  Day 1

• Estimated functional independence measure score before Covid-19

  Day 1

• Estimated dyspnea symptoms before Covid-19

  Day 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Post-COVID patient

You may qualify if:

• Post-COVID patient hospitalized in rehabilitation center
• Admission in Intensive Care Unit with proven COVID-19 disease before

You may not qualify if:

• Patients not willing to participate via using their medical files

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead

Study Sites (3)

Etablissement de santé Filieris

Freyming-Merlebach, Moselle, 57800, France

Location

Hopital Legouest

Metz, Moselle, 57000, France

Location

CHR Metz Thionville

Metz, Moselle, 57085, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2020
• First Posted: August 21, 2020
• Study Start: April 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: May 1, 2022
• Last Updated: September 22, 2022

Record last verified: 2022-09

Locations

FR (3)