Impact of COVID-19 Outbreak on the Alcohol Consumption in Patients With Alcohol-related Liver Disease (ICoLD)

May 6, 2021 updated by: King's College Hospital NHS Trust

Impact of COVID-19 Outbreak on the Alcohol Consumption in Patients With Alcohol-related Liver Disease

The lockdown consequent to Coronavirus outbreak has had a differential impact on the drinking behaviour on the general population. The impact is unknown on the people with underlying chronic liver disease related to alcohol as some of them may have complex psychosocial background. The alcohol consumption in people with Alcohol-related Liver Disease (ArLD) is either due to alcohol dependence or related to their lifestyle. Alcohol dependence is a chronic relapsing remitting condition and this is associated with 60% mortality at 5 years in people who continue drinking.

Recovery from alcohol-use disorder (AUD) has been made more difficult during lock-down because peer support meetings such as Alcoholics Anonymous (AA) have no longer been taking place; a majority of the residential rehabilitation centres have closed or are no longer accepting admissions (PHE, 2020) and the single detoxification unit in London has been requisitioned as a COVID-19 step-down facility.

The aim of the study is to understand the influence of lockdown on the craving of alcohol and severity of alcohol dependence in patients with ArLD. The results from the study will enable us to identify the factors influencing the drinking behaviour during lockdown and a subsequent impact on episodes of decompensation and mortality.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

ICoLD, is a collaborative study between the King's College Hospital and SLaM. This is an observational self-report questionnaire study. The study population will comprise of people with alcohol-related chronic liver disease attending the Liver Outpatients and those admitted to the King's College Hospital. The study groups will be people who were abstinent of alcohol and people who have had history of alcohol consumption prior to lockdown.

The study will ascertain drinking behaviour prior to lock down and during lock down/COVID restrictions. The study uses the Severity of Alcohol Dependence Questionnaire (SADQ) to ascertain the severity of physiological dependence and the Obsessive compulsive Drinking Scale (OCDS) to characterise craving. The SADQ, OCDS and detailed Alcohol history is usually collected as a standard of care in patients with AUD.

The study will also investigate factors that could influence drinking behaviour during lockdown such as access to alcohol, affordability, pub closure/less socialising, boredom, time to reflect on health and psycho-social factors. Data on drinking behaviour, SADQ score and OCDS will be collected at any future lockdowns.

Patients with ArLD will be identified from the Liver outpatients or approached during their Hospital admission. Approximately, 700 patients with ArLD are followed in the Liver outpatients. 200 patients will be enrolled during the lockdown period, considering drop outs and a proportion of patients not willing to participate in the study. The study population will be followed up for a year after the final lockdown/COVID restrictions are lifted. No statisticians were involved in planning this study as it is a pilot study to generate hypotheses regarding the drivers of changes in drinking in this population during lockdown.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Naina Shah, MBBS, MRCP (GIM), MRCP
  • Phone Number: 02032999000
  • Email: naina.shah1@nhs.net

Study Locations

  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • Recruiting
        • Institute of Liver Studies
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with alcohol-related chronic liver disease

Description

Inclusion Criteria:

  • Age >18 years.
  • People with alcohol related Liver disease

Exclusion Criteria:

  • Patient lacks capacity to consent to the study, e.g. due to hepatic encephalopathy, alcohol-related brain damage, or pre-existing learning disability
  • Aged <18 years old
  • Patients unable to understand English
  • Patients being considered for liver transplant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Alcohol-related liver disease
Diagnostic test: Study questionnaire
Study questionnaire related to drinking behaviour

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Episodes of Hepatic decompensation
Time Frame: 24 months
24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College Hospital NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2020

Primary Completion (Anticipated)

July 31, 2022

Study Completion (Anticipated)

July 31, 2022

Study Registration Dates

First Submitted

May 5, 2021

First Submitted That Met QC Criteria

May 5, 2021

First Posted (Actual)

May 6, 2021

Study Record Updates

Last Update Posted (Actual)

May 10, 2021

Last Update Submitted That Met QC Criteria

May 6, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 284173

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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