Clinical trial NCT04352491: An Online Survey to Understand Feelings Related to COVID-19 Among ILBS Patients With Liver Disease
Official title: An Online Survey to Understand Feelings Related to COVID-19 Among ILBS Patients With Liver Disease (FEELIV COVID)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID 19
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2020-04-20
Enrollment: 347
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have shown at ILBS between 1st January 2018 and 31st March 2020 will be considered as currently being enrolled at ILBS for treatment. Only their data will be used for the purpose of this study.

Brief 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

Detailed 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.

Eligibility criteria: Inclusion Criteria:

- Patients who have shown at Institute of Liver \& Biliary Sciences (ILBS) between 1st January 2018 and 31st March 2020 will be considered as currently being enrolled at ILBS for treatment.

Exclusion Criteria:

- Incomplete questionnaires

Primary outcomes:
measure: Assessment of the fear levels during the COVID-19 disease pandemic among patients with Liver disease (currently under treatment from ILBS)
timeFrame: Day 0
measure: Assessment of the anxiety levels during the COVID-19 disease pandemic among patients with Liver disease (currently under treatment from ILBS)
timeFrame: Day 0
measure: Assessment of the stress levels during the COVID-19 disease pandemic among patients with Liver disease (currently under treatment from ILBS)
timeFrame: Day 0
Secondary outcomes:
measure: Association between presence of Liver disease and fear levels
timeFrame: Day 0
measure: Association between presence of Liver disease and anxiety levels
timeFrame: Day 0
measure: Association between presence of Liver disease and stress levels
timeFrame: Day 0
measure: Correlation between Fear and Child-Turcotte-Pugh Score
timeFrame: Day 0
measure: Correlation between anxiety and Child-Turcotte-Pugh Score
timeFrame: Day 0
measure: Correlation between stress and Child-Turcotte-Pugh Score
timeFrame: Day 0
measure: Correlation between fear and Model for End Stage Liver Disease Score
timeFrame: Day 0
measure: Correlation between anxiety and Model for End Stage Liver Disease Score
timeFrame: Day 0
measure: Correlation between stress and Model for End Stage Liver Disease Score
timeFrame: Day 0
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
affiliation: Institute of Liver & Biliary Sciences
name: Dr Shiv Kumar Sarin, DM
role: STUDY_DIRECTOR
References: