An interventional study of brief intervention in Alcohol-related Liver Disease, Alcohol Use Disorder and Metabolic and Alcohol Related/Associated Liver Disease, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Recruiting at 2 sites in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-07.
Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Not applicable, Interventional, and Screening
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.
2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.
This study's planned enrollment of 350 is above the median of 50 across 1,323 interventional studies indexed under Liver Diseases.
Browse Liver Diseases studies →Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 268 studies on the registry; 61 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Never decompensated patients with ArLD suspicion
Young patients with risk alcohol intake and without liver disease
Previously or currently decompensated patients • Age over 30
Patients without significant liver disease
Behavioral: brief intervention
Behavioral: brief intervention
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).
Also known as: Diangostic test, Hepatology evaluation
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.
Time frame: 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)
Time frame: 1.5
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)
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
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)
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
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)
Time frame: 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)
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
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)
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
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
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Hospital Universitari Vall d'Hebron Research Institute