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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 350
- Locations
- 4
- Primary Endpoint
- efficacy of medical interventional and psychologist
Study Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- 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(1.5 years)
- to assess the impact of the intervention on the underlying liver disease (fibrosis and steatosis degree and rate of complications/decompensations).(1.5 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(2 years)
- to identify the risk factors associated to the late diagnosis of AUD in young population under 30yo(1.5 years)
- to identify the risk factors associated to the late diagnosis of advanced liver disease in patients with compensated vs. decompensated ALD(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(2 years)