Alcohol-related Liver DiseaseNCT04876443
Impact of COVID-19 Outbreak on the Alcohol Consumption in Patients With Alcohol-related Liver Disease (ICoLD)
An observational study of Alcohol-related Liver Disease and Alcohol Dependence, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol-related Liver Disease, Alcohol Dependence, Alcohol Withdrawal
- What is being tested?
- Study questionnaire
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Oct 2020to 31 Jul 2022
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients with alcohol-related chronic liver disease
Who may be able to join
- Age >18 years.
- People with alcohol related Liver disease
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Institute of Liver Studies
London, SE5 9RS
Naina Shah, MBBS, MRCP (GIM), MRCP, 02032999000, naina.shah1@nhs.net
Refah Z Ahmed, BA MSc, 02032997150, refah.ahmed1@nhs.net
About this study
Official title: 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.
Read the 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.
- Being tested
- Study questionnaire
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study questionnaireDiagnostic test
Study questionnaire related to drinking behaviour
| Study group | Role | What they receive |
|---|---|---|
| Alcohol-related liver disease | Not described Receives: Diagnostic Test: Study questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Episodes of Hepatic decompensation
Measured: 24 months
Secondary outcomes (1)
Mortality
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start8 Oct 2020
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol-related Liver DiseaseStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876443
- Sponsor's protocol ID
- 284173
- Status last verified
- May 2021
- First submitted
- 5 May 2021
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of COVID-19 Outbreak on the Alcohol Consumption in Patients With Alcohol-related Liver Disease
- ClinicalTrials.gov ID
- NCT04876443
- Acronym / sponsor ID
- 284173
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 6 May 2021 (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 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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alcohol-related liver disease | – | Diagnostic Test: Study questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with alcohol-related chronic liver disease
Key inclusion criteria (2 listed)
- Age >18 years.
- People with alcohol related Liver disease
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Study questionnaireStudy questionnaire related to drinking behaviour | Diagnostic test | Alcohol-related liver disease |
Primary outcome
Episodes of Hepatic decompensation
Time frame: 24 months
1 secondary outcome
Mortality
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Individual participant dataSharing planned: No
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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.
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 Alcohol-related Liver Disease and Alcohol Dependence, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 10 May 2021. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Naina Shah, MBBS, MRCP (GIM), MRCP (02032999000, naina.shah1@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Episodes of Hepatic decompensation (time frame: 24 months). 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 10 May 2021.