Psychological Care of Oncology Patients With Post-traumatic Stress in the Context of a COVID-19
NCT04747249
COVID-19, Coronaviridae Infections
Caen, France
View Trial DetailsNCT Number: NCT04523051
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.
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Observational
Etablissement de santé Filieris, Freyming-Merlebach, Moselle, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Day 1
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).
Time frame: Day 30
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).
Time frame: Day 180
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).
Time frame: Day 1
weight of the patient
Time frame: Day 180
weight of the patient after hospitalization
Time frame: Day 1
age of the patient at the admission in rehabilitation center
Time frame: Day 1
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). Estimating the functional independence score before the disease.
Time frame: Day 1
The modified Medical Research Council (mMRC) scale is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day on a scale from 0 to 4 (0= no breathlessness except on strenuous exercise and 4= too breathless to leave the house, or breathless when dressing or undressing).
Time frame: Day 1
Length of stay in ICU unit for Covid-19
Time frame: Day 1
Length of stay in acute care for Covid-19
Time frame: Day 180
Length of stay in rehabilitation centers
Time frame: Day 1
Length of Invasive mechanical ventilation during the stay
Time frame: Day 180
Presence of pressure ulcers, stage and localization during the management of patient
Time frame: Day 1
Risk of bedsore with the Braden scale. The Braden score consists of six subscales (sensory perception, moisture, activity, mobility, nutrition and friction/shear) representing the most commonly occuring risk factors for pressure ulcers and is scored from 6 to 23, with lower scores representing higher risk of developing pressure ulcers.
Time frame: Day 1
Presence of joint limitation during the management
Time frame: Day 1
Dominant side of the patient
Time frame: Day 180
Presence of psychic disorders like delirium, sleep disorders, anxiety, sadness of mood, loss of appetite, suicidal thoughts, asking for psychologist care during the stay
Time frame: Day 1
Muscle strength examination according to Medical Research Council muscle strength scale. This scale involves testing key muscles from the upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale with 0= no muscle activation and 5= muscle activation against examiner's full resistance, full range of motion.
Time frame: Day 180
Muscle strength examination according to Medical Research Council muscle strength scale. This scale involves testing key muscles from the upper and lower extremities against the examiner's resistance and grading the patient's strength on a 0 to 5 scale with 0= no muscle activation and 5= muscle activation against examiner's full resistance, full range of motion.
Time frame: Day 1
Dyspnea symptoms according to the modified Medical Research Council (mMRC) scale. The mMRC is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day on a scale from 0 to 4 (0= no breathlessness except on strenuous exercise and 4= too breathless to leave the house, or breathless when dressing or undressing
Time frame: Day 180
Dyspnea symptoms according to the modified Medical Research Council (mMRC) scale. The mMRC is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day on a scale from 0 to 4 (0= no breathlessness except on strenuous exercise and 4= too breathless to leave the house, or breathless when dressing or undressing
Time frame: Day 1
Functional exercise capacity measured by a 6 minutes Walking test
Time frame: Day 180
Destination of patients at discharge from rehabilitation center. For the destination there is 4 possibility: the return home, institutionalization, re-hospitalization or other (specify where).
Time frame: Day 1
The measuring of oxygen saturation of the blood by means of an oximeter at the admission
Time frame: Day 180
The measuring of oxygen saturation of the blood by means of an oximeter at the discharge
Time frame: Day 180
Hoffman's sign is a test to examine the reflexes of the upper extremities.
Time frame: Day 180
The Babinski reflex is obtained by stimulating the external portion of the sole.
Time frame: Day 1
gender of participants
Time frame: Day 1
presence of anosmia, dysgeusia, swallowing disorders, phonation disorders, phasic disorders, confusion, headache, urinary or fecal incontinence at the admission
Time frame: Day 180
presence of anosmia, dysgeusia, swallowing disorders, phonation disorders, phasic disorders, confusion, headache, urinary or fecal incontinence at the discharge
Centre Hospitalier Régional Metz-Thionville
Other
Rehabilitation After Admission in Intensive Care Unit for COVID-19: an Observational Study
Acronym: RECOVER
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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