An Online Survey to Understand Feelings Related to COVID-19 Among ILBS Patients With Liver Disease

NCT04352491 | Completed

• 1 other identifier: ILBS-COVID-03
• Study Type: observational
• Target: 347
• Locations: 1 country
• Sites: 1

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

Conditions

COVID 19

Outcome Measures

Primary Outcomes (3)

• Assessment of the fear levels during the COVID-19 disease pandemic among patients with Liver disease (currently under treatment from ILBS)

  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.

  Day 0

• Assessment of the anxiety levels during the COVID-19 disease pandemic among patients with Liver disease (currently under treatment from ILBS)

  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.

  Day 0

• Assessment of the stress levels during the COVID-19 disease pandemic among patients with Liver disease (currently under treatment from ILBS)

  Following questionnaire will be used o Stress levels: DASS - 21 Scale Depression Anxiety Stress Asymptomatic ≤4 ≤3 ≤7 Symptomatic \>4 \>3 \>7

  Day 0

Secondary Outcomes (9)

• Association between presence of Liver disease and fear levels

  Day 0

• Association between presence of Liver disease and anxiety levels

  Day 0

• Association between presence of Liver disease and stress levels

  Day 0

• Correlation between Fear and Child-Turcotte-Pugh Score

  Day 0

• Correlation between anxiety and Child-Turcotte-Pugh Score

  Day 0

Study Arms (1)

Patients with liver disease

All people who have shown at Institute of Liver and Biliary Sciences (1st January 2018 - 31st March 2020), will be sent the SMS for participation.

Other: No intervention

Interventions

No intervention OTHER

No intervention

Patients with liver disease

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- 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.

You may not qualify if:

• \- Incomplete questionnaires

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

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 Officials

• Dr Shiv Kumar Sarin, DM

  Institute of Liver & Biliary Sciences

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 20, 2020
• Study Start: April 24, 2020
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: June 17, 2020

Record last verified: 2020-04

Locations

IN (1)