Alcohol-related Liver DiseaseStopALDNCT06403332
Study of the Drivers of Late Diagnosis of Alcohol Related Diseases, Alone or in Combination With Metabolic Dysfunconal Associated Fatty Liver Disease, Implementation and Evaluation of Itnerventions to Reduce Its Burden.
A study testing brief intervention in people with Alcohol-related Liver Disease and Alcohol Use Disorder, run by Hospital Universitari Vall d'Hebron Research Institute at 2 sites in Spain.
Trial summary
Excessive alcohol use is a leading risk factor for preventable disability and death. Alcohol-related liver disease (ALD) is one of the better-known detrimental consequences of alcohol abuse and is the main cause of disability-adjusted life years (DALYs) in European adults. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol-related Liver Disease, Alcohol Use Disorder, Metabolic and Alcohol Related/Associated Liver Disease
- What is being tested?
- brief intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 2 sitesSpain
- Study dates
- 2 Feb 2023to 6 Dec 2024
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Never decompensated patients with ArLD suspicion
- Age over 30
- Diagnosis of AUD identified by the AUDIT test or excessive alcohol consumption, i.e., suspicion of current or recent (within one year) AUD or persistent alcohol intake of more than 40 g/daily for women and 60 g/daily for men based on medical history or self-reported history of excessive alcohol use, stigmata of alcohol use on physical exam, liver chemistry abnormalities, and/or alcohol-induced organ involvement other than decompensated liver disease
- Alanine (ALT) and aspartate aminotransferases (AST) <5 times upper normal limit
- Bilirubin <3 mg/dL or/and
- AST/ALT ratio >1.5 or/and
- GGT >100 mg/dL • Patients with a past history of decompensated advanced liver disease (i.e., episodes of jaundice, ascites, hepatic encephalopathy, variceal bleeding, hepatorenal syndrome) or known HCC
- Patients with severe extrahepatic disease or terminal illness
Young patients with risk alcohol intake and without liver disease
- Age between 18-30 years
- Diagnosis of AUD identified by the AUDIT test or for whom there is a high suspicion of current or recent (within one year) AUD or persistent alcohol intake of more than 40 g/daily for women and 60 g/daily for men based on medical history or self-reported history of excessive alcohol use, stigmata of alcohol use on physical exam and/or alcohol-induced organ involvement other than decompensated liver disease
- Normal liver test including AST, ALT, bilirubin and GGT. • Patients with a past history of decompensated advanced liver disease (i.e., episodes of jaundice, ascites, hepatic encephalopathy, variceal bleeding, hepatorenal syndrome) or known HCC
- Patients with severe extrahepatic disease or terminal illness
Previously or currently decompensated patients • Age over 30
- Diagnosed ALD with a current or previous liver-related decompensation (i.e., ascites or edemas, hepatic encephalopathy, hepatocellular carcinoma, upper gastrointestinal bleeding, spontaneous bacterial peritonitis or alcoholic hepatitis) • Terminal illness with less than 6 months live expectancy (except advanced hepatocellular carcinoma)
- Previous liver transplant recipient
Patients without significant liver disease
- Age over 30
- Alcohol intake of <10g per day without current or previous AUD or heavy alcohol intake • Significant liver pathology MASLD patients with a maximum alcohol intake of 20g per day.
- Age over 30
- Alcohol intake (<20g/day in women and <30g/day in men),
- Patients with obesity and/or diabetes mellitus type 2 and/or metabolic syndrome defined by the presence of two or more of the Eslam et al. criteria. • Patients with a past history of decompensated advanced liver disease (i.e., episodes of jaundice, ascites, hepatic encephalopathy, variceal bleeding, hepatorenal syndrome) or known HCC
- Patients with severe extrahepatic disease or terminal illness
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Joan Genescà, MD PhD
Meritxell Ventura, MD
- Recruiting
University Hospital Vall d'Hebron
Barcelona, 08035
Meritxell Ventura, 932746000 ext. 6559, meritxell.ventura@vallhebron.cat
Juan Manuel Pericas, 932746000 ext. 6561, juanmuel.pericas@vallhebron.cat
About this study
Excessive alcohol use is a leading risk factor for preventable disability and death. Alcohol-related liver disease (ALD) is one of the better-known detrimental consequences of alcohol abuse and is the main cause of disability-adjusted life years (DALYs) in European adults. ALD is the main cause of cirrhosis globally and is responsible for 60% of cirrhosis in Europe and North America.
Importantly, another etiology of liver disease is on the rise due to the epidemics of obesity and diabetes mellitus in Western countries, i.e., metabolic dysfunction associated fatty liver disease (MAFLD). ALD and MAFLD are largely shaped by social determinants of health (SDH) and lead to mounting health inequalities. Moreover, ALD is subject to strong stigmatization, particularly amongst women, which often leads to lack of inquiry by health professionals. Alone or in combination (MAFLD-OH), both diseases represent a challenge for epidemiologists, clinicians and policy makers in charge of health systems' organization. One of the hurdles to reduce the burden of ALD is the lack of early detection of asymptomatic liver disease among patients with alcohol use disorder (AUD) and heavy drinkers. The only measure that has been proven effective in any phase of the disease is to either stop, compensate, or reverse the liver disease progression, is alcohol abstinence. We hypothesize that establishing effective screening programs to identify patients with ALD and related disorders, coupled with effective treatment will lead to more positive outcomes in prognosis. The central aim of the StopALD Project is to identify patients with advanced ALD during the asymptomatic phases of the disease, as well as identifying the factors related with the lack of early detection to better implement interventions so to tackle both the lack of early detection of ALD and heavy drinking patterns among young people before ALD occurs.
- Conditions
- Alcohol-related Liver Disease, Alcohol Use Disorder, Metabolic and Alcohol Related/Associated Liver Disease, Metabolic Disfunction Associated Steatotic Liver Disease
- Being tested
- brief intervention
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brief interventionBehavioural
Also called Diangostic test, Hepatology evaluation
The intervention for cohort A (intervention arm) based on brief intervention on alcohol consumption performed by a psycologist, medical visit peformed by an hepatologist including assessment of underlying liver disease with non invasive test (i.e Fibroscan and lab work).
| Study group | Role | What they receive |
|---|---|---|
| Cohort A intervention | Experimental | Not described Receives: Behavioral: brief intervention |
| Cohort A non intervention | No intervention | Not described |
| Cohort B intervention | Experimental | Not described Receives: Behavioral: brief intervention |
| Cohort B no intervention | No intervention | Not described |
| Control grup no significant liver disease | No intervention | Not described |
| Control group MASLD | No intervention | Not described |
| Control group decompensated ArLD | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of medical interventional and psychologist
To assess the efficacy of medical intervention including a hepatology visit, brief intervention and counseling provided by a psychologist as well as the non-invasive assessment of underlying fibrosis degree (Fibroscan improvement of 2 or more points) on alcohol abstinence (assesses by autoreport number of standard units of alcohol) and relapses compared to current standard of care.
Measured: 1.5 years
to assess the efficacy of an in-situ psychologist counseling including a motivational interview among young patients with heavy drinking on alcohol abstinence and relapses compared to current SOC
to assess the efficacy of an in-situ psychologist counseling including a motivational interview among young patients with heavy drinking on alcohol abstinence and relapses compared to current SOC (alcohol intake assessed by number of standard drinks)
Measured: 1.5
Secondary outcomes (6)
to assess the impact of the intervention on the underlying liver disease (fibrosis and steatosis degree and rate of complications/decompensations).
to assess the impact of the intervention on the underlying liver disease (fibrosis and steatosis degree and rate of complications/decompensations). Fibrosis assessed by Fibroscan fibrosis improvement defined as improvement of 2 or more points in the fibroscan. Liver events (i.e hepatic encephalopathy, ascites, edemas, upper gastrointestinal bleeding, alcohol associated hepatitis)
Measured: 1.5 years
to investigate the prevalence of MAFLD-OH amongst these patients and whether metabolic risk factors increase the prevalence and severity at diagnosis of advanced liver fibrosis in patients with AUD or excessive alcohol intake
to investigate the prevalence of MAFLD-OH amongst these patients and whether metabolic risk factors increase the prevalence and severity at diagnosis of advanced liver fibrosis in patients with AUD or excessive alcohol intake. Severity of Fibrosis assessed by Fibroscan (severe disease Fibroscan > 8, % of severe disease between ALD group and MAFLD+OH)
Measured: 1.5 years
to identify the risk factors associated to the late diagnosis of advanced liver disease in patients with compensated vs. decompensated ALD
to identify the risk factors associated to the late diagnosis of advanced liver disease in patients with compensated vs. decompensated ALD. (Specific design questionaries with socieconomical, mental health, educational factors)
Measured: 1.5 years
to identify the risk factors associated to the late diagnosis of AUD in young population under 30yo
to identify the risk factors associated to the late diagnosis of AUD in young population under 30yo (Specific design questionaries with socieconomical, mental health, educational factors)
Measured: 1.5 years
to analyze the associations between sociocultural determinants of alcohol-related issues in the healthcare system and the late diagnosis of AUD, excessive alcohol intake and ALD
to analyze the associations between sociocultural determinants of alcohol-related issues in the healthcare system and the late diagnosis of AUD, excessive alcohol intake and ALD (Specific design questionaries with socieconomical, mental health, educational factors)
Measured: 2 years
to evaluate the cost-effectiveness and cost-equity of the proposed interventions to assess the late diagnosis of alcohol excessive intake and alcohol-related disease
to evaluate the cost-effectiveness and cost-equity of the proposed interventions to assess the late diagnosis of alcohol excessive intake and alcohol-related disease
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start2 Feb 2023
- Primary completion6 Jun 2024 (estimated)
- Study completion6 Dec 2024 (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 Hospital Universitari Vall d'Hebron Research InstituteThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Universitat Pompeu Fabra, IDIAPJgol
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403332
- Sponsor's protocol ID
- PR(AG)30/2023
- Acronym
- StopALD
- Status last verified
- May 2024
- First submitted
- 24 Apr 2024
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Drivers of Late Diagnosis of Alcohol Related Diseases, Alone or in Combination With Metabolic Dysfunconal Associated Fatty Liver Disease, Implementation and Evaluation of Itnerventions to Reduce Its Burden.
- ClinicalTrials.gov ID
- NCT06403332
- Acronym / sponsor ID
- StopALD / PR(AG)30/2023
- Conditions
- Alcohol-related Liver Disease, Alcohol Use Disorder, Metabolic and Alcohol Related/Associated Liver Disease, Metabolic Disfunction Associated Steatotic Liver Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Collaborators
- Universitat Pompeu Fabra, IDIAPJgol
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- 6 Jun 2024 (estimated)
- Study completion
- 6 Dec 2024 (estimated)
- First posted
- 7 May 2024 (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.
Excessive alcohol use is a leading risk factor for preventable disability and death. Alcohol-related liver disease (ALD) is one of the better-known detrimental consequences of alcohol abuse and is the main cause of disability-adjusted life years (DALYs) in European adults. ALD is the main cause of cirrhosis globally and is responsible for 60% of cirrhosis in Europe and North America.
Importantly, another etiology of liver disease is on the rise due to the epidemics of obesity and diabetes mellitus in Western countries, i.e., metabolic dysfunction associated fatty liver disease (MAFLD). ALD and MAFLD are largely shaped by social determinants of health (SDH) and lead to mounting health inequalities. Moreover, ALD is subject to strong stigmatization, particularly amongst women, which often leads to lack of inquiry by health professionals. Alone or in combination (MAFLD-OH), both diseases represent a challenge for epidemiologists, clinicians and policy makers in charge of health systems' organization. One of the hurdles to reduce the burden of ALD is the lack of early detection of asymptomatic liver disease among patients with alcohol use disorder (AUD) and heavy drinkers. The only measure that has been proven effective in any phase of the disease is to either stop, compensate, or reverse the liver disease progression, is alcohol abstinence. We hypothesize that establishing effective screening programs to identify patients with ALD and related disorders, coupled with effective treatment will lead to more positive outcomes in prognosis. The central aim of the StopALD Project is to identify patients with advanced ALD during the asymptomatic phases of the disease, as well as identifying the factors related with the lack of early detection to better implement interventions so to tackle both the lack of early detection of ALD and heavy drinking patterns among young people before ALD occurs.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort A intervention | Experimental | Behavioral: brief intervention |
| Cohort A non intervention | No intervention | – |
| Cohort B intervention | Experimental | Behavioral: brief intervention |
| Cohort B no intervention | No intervention | – |
| Control grup no significant liver disease | No intervention | – |
| Control group MASLD | No intervention | – |
| Control group decompensated ArLD | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| brief interventionAlso: Diangostic test, Hepatology evaluationThe intervention for cohort A (intervention arm) based on brief intervention on alcohol consumption performed by a psycologist, medical visit peformed by an hepatologist including assessment of underlying liver disease with non invasive test (i.e Fibroscan and lab work). | Behavioural | Cohort A intervention, Cohort B intervention |
Primary outcome
efficacy of medical interventional and psychologist
Time frame: 1.5 years
To assess the efficacy of medical intervention including a hepatology visit, brief intervention and counseling provided by a psychologist as well as the non-invasive assessment of underlying fibrosis degree (Fibroscan improvement of 2 or more points) on alcohol abstinence (assesses by autoreport number of standard units of alcohol) and relapses compared to current standard of care.
to assess the efficacy of an in-situ psychologist counseling including a motivational interview among young patients with heavy drinking on alcohol abstinence and relapses compared to current SOC
Time frame: 1.5
to assess the efficacy of an in-situ psychologist counseling including a motivational interview among young patients with heavy drinking on alcohol abstinence and relapses compared to current SOC (alcohol intake assessed by number of standard drinks)
6 secondary outcomes
to assess the impact of the intervention on the underlying liver disease (fibrosis and steatosis degree and rate of complications/decompensations).
Time frame: 1.5 years
to investigate the prevalence of MAFLD-OH amongst these patients and whether metabolic risk factors increase the prevalence and severity at diagnosis of advanced liver fibrosis in patients with AUD or excessive alcohol intake
Time frame: 1.5 years
to identify the risk factors associated to the late diagnosis of advanced liver disease in patients with compensated vs. decompensated ALD
Time frame: 1.5 years
to identify the risk factors associated to the late diagnosis of AUD in young population under 30yo
Time frame: 1.5 years
to analyze the associations between sociocultural determinants of alcohol-related issues in the healthcare system and the late diagnosis of AUD, excessive alcohol intake and ALD
Time frame: 2 years
to evaluate the cost-effectiveness and cost-equity of the proposed interventions to assess the late diagnosis of alcohol excessive intake and alcohol-related disease
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing brief intervention in people with Alcohol-related Liver Disease and Alcohol Use Disorder, run by Hospital Universitari Vall d'Hebron Research Institute at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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 Portollano (634 832 759 ext. 29778, cristina.portellano@vhir.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of medical interventional and psychologist (time frame: 1.5 years). The study lists 2 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 7 May 2024.