NCT04876443

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 8, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 6, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

May 10, 2021

Status Verified

May 1, 2021

Enrollment Period

1.8 years

First QC Date

May 5, 2021

Last Update Submit

May 6, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Episodes of Hepatic decompensation

    24 months

Secondary Outcomes (1)

  • Mortality

    24 months

Study Arms (1)

Alcohol-related liver disease

Diagnostic Test: Study questionnaire

Interventions

Study questionnaireDIAGNOSTIC_TEST

Study questionnaire related to drinking behaviour

Alcohol-related liver disease

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with alcohol-related chronic liver disease

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Liver Studies

London, SE5 9RS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Central Study Contacts

Naina Shah, MBBS, MRCP (GIM), MRCP

CONTACT

Refah Z Ahmed, BA MSc

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2021

First Posted

May 6, 2021

Study Start

October 8, 2020

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

May 10, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations