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There are 2 clinical trials
The current outbreak of COVID-19 pandemic has been marked by severe psychological problems. People around the world experienced a similarly frightening public health emergency, on a global scale, with the spread of this corona infection. (1) Studies of the Severe Acute Respiratory Syndrome (SARS) outbreaks that occurred in Canada, Taiwan, and Hong Kong found that the enormous emotional burden carried by those health care workers who were on the front lines of the battle against the disease led to psychological morbidity like anxiety, stress and even further leads to Post traumatic stress disorder. The initial phase of the COVID-19 outbreak in China in 2020 also reported more than half of the respondents rated the psychological impact as moderate-to-severe, and about one-third reported moderate-to-severe anxiety in general population.(2) - The chances of Fear, anxiety and stress are even higher in Individuals with preexisting liver disease as they have restriction of services for getting treatment. Moreover, they can have the following additional issues: - Fear of severe form of Corona present (as presented in most of the media and research) - Fear of dying - Added uncertainty - Family members also worried
Description: Following questionnaire will be used For Fear of COVID-19: FEAR OF COVID-19 Scale Fear of Coronavirus-19 Scale: The participants indicate their level of agreement with the statements using a five-item Likert-type scale. Answers included "strongly disagree," "disagree," "neither agree nor disagree," "agree," and "strongly agree". The minimum score possible for each question is 1, and the maximum is 5. A total score is calculated by adding up each item score (ranging from 7 to 35). The higher the score, the greater the fear of cororonavirus-19.
Measure: Assessment of the fear levels during the COVID-19 disease pandemic among patients with Liver disease (currently under treatment from ILBS) Time: Day 0Description: Following questionnaire will be used o For, anxiety: DASS - 21 Scale Depression, Anxiety and Stress Scale - 21 Items (DASS-21) Depression Anxiety Stress Scale (DASS)-21: The DASS-21 is based on three subscales of depression, stress, and anxiety and each subscale consists of seven questions each. Each subscale comprises of seven statements regarding how the test subject was feeling over the last week and four responses ranging from 0- did not apply to me at all, 1- applied to me some of the time, 2- applied to me for a considerable amount of time to 3- applied to me very much/most of the time. The scoring system is of the Likert type and the total score for each subscale gives the severity of that very symptom which has a range from 0 to 21 for each subscale.
Measure: Assessment of the anxiety levels during the COVID-19 disease pandemic among patients with Liver disease (currently under treatment from ILBS) Time: Day 0Description: Following questionnaire will be used o Stress levels: DASS - 21 Scale Depression Anxiety Stress Asymptomatic ≤4 ≤3 ≤7 Symptomatic >4 >3 >7
Measure: Assessment of the stress levels during the COVID-19 disease pandemic among patients with Liver disease (currently under treatment from ILBS) Time: Day 0Description: Following questionnaire will be used o For Fear of COVID-19: FEAR OF COVID-19 Scale
Measure: Association between presence of Liver disease and fear levels Time: Day 0Description: Following questionnaire will be used o For, anxiety levels: DASS - 21 Scale Depression, Anxiety and Stress Scale - 21 Items (DASS-21) Higher Scores mean worse condition
Measure: Association between presence of Liver disease and anxiety levels Time: Day 0Description: Following questionnaire will be used o For stress levels: DASS - 21 Scale Depression, Anxiety and Stress Scale - 21 Items (DASS-21) Higher Scores mean worse condition.
Measure: Association between presence of Liver disease and stress levels Time: Day 0Description: Higher Scores mean worse condition
Measure: Correlation between Fear and Child-Turcotte-Pugh Score Time: Day 0Description: Higher Scores mean worse condition
Measure: Correlation between anxiety and Child-Turcotte-Pugh Score Time: Day 0Description: Higher Scores mean worse condition
Measure: Correlation between stress and Child-Turcotte-Pugh Score Time: Day 0Description: Higher Scores mean worse condition
Measure: Correlation between fear and Model for End Stage Liver Disease Score Time: Day 0Description: Higher Scores mean worse condition
Measure: Correlation between anxiety and Model for End Stage Liver Disease Score Time: Day 0Description: Higher Scores mean worse condition
Measure: Correlation between stress and Model for End Stage Liver Disease Score Time: Day 0Background: The COVID19 and liver relationships are very rare. The preliminary Chinese data indicate that 2-11% of patients treated for COVID19 had an underlying chronic liver disease. However, there is no clinical data on morbi-mortality in this context. Objectives: Primary Objective: Evaluate the mortality related to Covid-19 in patients with a chronic liver disease Secondary objectives: - Evaluate the mortality (liver-related and no liver-related) due to the Covid-19 according to the cirrhotic status, an history of hepatocellular carcinoma, an immunosuppressive treatment and its type, the etiology-ies of liver disease at the diagnosis of Covid-19 (viral hepatitis -B and/or C-, liver disease related to alcohol consumption, metabolic syndrome, hemochromatosis, immune liver disease, other or unknown), and comorbidities - Evaluate the liver morbidity related to Covid-19, including - incidence of liver biochemical abnormalities in patients with normal liver enzymes values or of a 2-fold increase of usual values for AST, ALT, GGT, Alcalines Phosphatasis - incidence of liver complications (acute hepatitis, liver insufficiency, decompensation of cirrhosis, encephalopathy, renal insufficiency) Patients: All patients with a liver disease (chronic or acute) with a positive diagnosis of Covid-19 assessed either by positive PCR or specific thoracic abnormalities at TDM Methodology: Observational ambispective study consisting exclusively of a collection of data from patients with liver diseases and managed for COVID 19 The data is collected and transcribed on a secure electronic eCRF hosted at the Assitance Publique des Hôpitaux de Paris and accessible online from the AFEF website Duration and organisation of the research: After information of the patients and making available a non-opposition form, the main demographic and clinical data related to the liver disease and to the COVID19 already collected in the patient's medical record will be collected in a dedicated e-CRF. Effective of the study: All consecutive patients included in the study whose data are collected e-CRF until 31/12/2020.
Description: defined with liver biopsy or non invasive tests of fibrosis or according the opinion of clinician
Measure: mortality rate according the stage of fibrosis and the cirrhotic status Time: Up to 30 daysDescription: acute hepatitis, liver insufficiency, decompensation of cirrhosis, encephalopathy, renal insufficiency
Measure: Incidence of liver complications Time: through patient follow-up, an average of 1 year