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

NCT ID: NCT04352491

Last Updated: 2020-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

347 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-24

Study Completion Date

2020-05-31

Brief Summary

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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

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* 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

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COVID 19

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr Shiv Kumar Sarin, DM

Role: STUDY_DIRECTOR

Institute of Liver & Biliary Sciences

Locations

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Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Site Status

Countries

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India

Other Identifiers

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ILBS-COVID-03

Identifier Type: -

Identifier Source: org_study_id

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