COVID 19NCT04352491
An Online Survey to Understand Feelings Related to COVID-19 Among ILBS Patients With Liver Disease
An observational study of COVID 19, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COVID 19
- How many people
- 347 participants
- Where
- 1 siteIndia
- Study dates
- 24 Apr 2020to 31 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Incomplete questionnaires
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: An Online Survey to Understand Feelings Related to COVID-19 Among ILBS Patients With Liver Disease (FEELIV COVID)
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
Read the 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.
- Conditions
- COVID 19
- Being tested
- No intervention
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
- 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.
Measured: 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
- Stress levels: DASS - 21 Scale Depression Anxiety Stress Asymptomatic ≤4 ≤3 ≤7 Symptomatic >4 >3 >7
Measured: Day 0
Secondary outcomes (9)
Association between presence of Liver disease and fear levels
Following questionnaire will be used
- For Fear of COVID-19: FEAR OF COVID-19 Scale
Measured: Day 0
Association between presence of Liver disease and anxiety levels
Following questionnaire will be used
- For, anxiety levels: DASS - 21 Scale Depression, Anxiety and Stress Scale - 21 Items (DASS-21) Higher Scores mean worse condition
Measured: Day 0
Association between presence of Liver disease and stress levels
Following questionnaire will be used
- For stress levels: DASS - 21 Scale Depression, Anxiety and Stress Scale - 21 Items (DASS-21) Higher Scores mean worse condition.
Measured: Day 0
Correlation between Fear and Child-Turcotte-Pugh Score
Higher Scores mean worse condition
Measured: Day 0
Correlation between anxiety and Child-Turcotte-Pugh Score
Higher Scores mean worse condition
Measured: Day 0
Correlation between stress and Child-Turcotte-Pugh Score
Higher Scores mean worse condition
Measured: Day 0
Correlation between fear and Model for End Stage Liver Disease Score
Higher Scores mean worse condition
Measured: Day 0
Correlation between anxiety and Model for End Stage Liver Disease Score
Higher Scores mean worse condition
Measured: Day 0
Correlation between stress and Model for End Stage Liver Disease Score
Higher Scores mean worse condition
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start24 Apr 2020
- Primary completion31 May 2020
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID 19Studies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Shiv Kumar Sarin, DM, Study director, Institute of Liver & Biliary Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04352491
- Sponsor's protocol ID
- ILBS-COVID-03
- Status last verified
- Apr 2020
- First submitted
- 14 Apr 2020
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Online Survey to Understand Feelings Related to COVID-19 Among ILBS Patients With Liver Disease (FEELIV COVID)
- ClinicalTrials.gov ID
- NCT04352491
- Acronym / sponsor ID
- ILBS-COVID-03
- Conditions
- COVID 19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 24 Apr 2020 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 20 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with liver disease | – | Other: No interventionAll people who have shown at Institute of Liver and Biliary Sciences (1st January 2018 - 31st March 2020), will be sent the SMS for participation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Incomplete questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Patients with liver disease |
Primary outcome
Assessment of the fear levels during the COVID-19 disease pandemic among patients with Liver disease (currently under treatment from ILBS)
Time frame: Day 0
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.
Assessment of the anxiety levels during the COVID-19 disease pandemic among patients with Liver disease (currently under treatment from ILBS)
Time frame: Day 0
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.
Assessment of the stress levels during the COVID-19 disease pandemic among patients with Liver disease (currently under treatment from ILBS)
Time frame: Day 0
Following questionnaire will be used o Stress levels: DASS - 21 Scale Depression Anxiety Stress Asymptomatic ≤4 ≤3 ≤7 Symptomatic >4 >3 >7
9 secondary outcomes
Association between presence of Liver disease and fear levels
Time frame: Day 0
Association between presence of Liver disease and anxiety levels
Time frame: Day 0
Association between presence of Liver disease and stress levels
Time frame: Day 0
Correlation between Fear and Child-Turcotte-Pugh Score
Time frame: Day 0
Correlation between anxiety and Child-Turcotte-Pugh Score
Time frame: Day 0
Correlation between stress and Child-Turcotte-Pugh Score
Time frame: Day 0
Correlation between fear and Model for End Stage Liver Disease Score
Time frame: Day 0
Correlation between anxiety and Model for End Stage Liver Disease Score
Time frame: Day 0
Correlation between stress and Model for End Stage Liver Disease Score
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Shiv Kumar Sarin, DM study director
Institute of Liver & Biliary Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID 19, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the fear levels during the COVID-19 disease pandemic among patients with Liver disease (currently under treatment from ILBS) (time frame: Day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2020.