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

COVID 19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04352491
• Other study ID #: ILBS-COVID-03
• Status: Completed
• Start date: April 24, 2020
• Est. completion date: May 31, 2020

Study information

• Verified date: April 2020
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 347
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID 19
• Liver Diseases

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
India	Institute of Liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Association between presence of Liver disease and fear levels	Following questionnaire will be used; o For Fear of COVID-19: FEAR OF COVID-19 Scale	Day 0
Secondary	Association between presence of Liver disease and anxiety levels	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	Day 0
Secondary	Association between presence of Liver disease and stress levels	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.	Day 0
Secondary	Correlation between Fear and Child-Turcotte-Pugh Score	Higher Scores mean worse condition	Day 0
Secondary	Correlation between anxiety and Child-Turcotte-Pugh Score	Higher Scores mean worse condition	Day 0
Secondary	Correlation between stress and Child-Turcotte-Pugh Score	Higher Scores mean worse condition	Day 0
Secondary	Correlation between fear and Model for End Stage Liver Disease Score	Higher Scores mean worse condition	Day 0
Secondary	Correlation between anxiety and Model for End Stage Liver Disease Score	Higher Scores mean worse condition	Day 0
Secondary	Correlation between stress and Model for End Stage Liver Disease Score	Higher Scores mean worse condition	Day 0