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Clinical Trial Summary

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


Clinical Trial Description

- As the Indian Government recommended the public to minimize face-to-face interaction and isolate them at home, potential respondents will be invited through a text message which will lead to a survey monkey page (designed by IT team at ILBS, New Delhi).

- All people who have shown at ILBS (1st January 2018 - 31st March 2020), will be sent the SMS for participation. They will be asked to provide phone numbers for retrieval of their Child-Turcotte-Pugh (CTP) and Model for End Stage Liver Disease (MELD) scores from hospital records. Patients with education more than 10th standard (or able to understand / read English) will only proceed with the survey.

- After clicking the link users will complete an online survey. The first page will give them basic information about the FEELIV-COVID survey and if they consent to participate, they will complete the survey. The decision to undertake the survey voluntarily, and will have no impact on their ongoing treatment.

- Informed consent will be obtained in the form of electronic name entry at the beginning of the survey. Their name entry will be taken as an approval to allow the investigators data regarding their Liver disease. Only the following data will be taken from the patient's records:

- Child-Turcotte-Pugh (CTP) score

- Model for End Stage Liver Disease (MELD) score

- Etiology of Liver Dysfunction

- No other data will be retrieved for the purpose of this study from patient's records. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04352491
Study type Observational
Source Institute of Liver and Biliary Sciences, India
Contact
Status Completed
Phase
Start date April 24, 2020
Completion date May 31, 2020

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