Evaluation of Liver Disease in Individuals Attending Alcohol Abuse Treatment - a Randomized Controlled Pilot Trial
- Conditions
- Liver Diseases
- Interventions
- Diagnostic Test: FibroscanDiagnostic Test: Blood samples
- Registration Number
- NCT05244720
- Lead Sponsor
- Zealand University Hospital
- Brief Summary
This pilot study aims to evaluate the feasibility of a non-blinded randomized controlled trial with a parallel group design of an invitation to an evaluation of liver disease (intervention) compared to standard care with no invitation, among individuals in alcohol abuse treatment.
- Detailed Description
Alcohol-related liver disease (ALD) is responsible for about 80% of all liver disease in Denmark. The prognosis for ALD is good, if detected early and abstinence is obtained. Unfortunately ALD is often diagnosed at a late state and the 1-year survival is only 30%.
Currently there is no available systematic screening for fibrosis/cirrhosis among patients with longterm abuse of alcohol and thereby high risk for developing ALD.
Transient elastography (TE) is a non-invasive, risk free and quick method of detecting fibrosis. TE is validated for diagnosing fibrosis and ruling out cirrhosis.
40 patients will be enrolled in the study with a 1:1 randomization. Baseline data is collected and informed concent is obtained at the local alcohol abuse treatment center, Novavi Køge. The fibroscan and blood samples are done at Zealand University Hospital, Køge. Follow-up is done after 6 months, by a project nurse, blinded to the intervention.
If the study proves to be feasible, our aim is to extend the study in order to investigate wether the interventions described above, could help decrease alcohol consumption/maintain abstinence for patients in alcohol treatment. Moreover the prevalence of fibrosis and cirrhosis found by fibroscan is examined.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- must be enrolled at alcohol treatment center Novavi Koege, Denmark
- Maximum 6 months of treatment at Novavi Koege
- known severe liver disease
- life expectancy less than 6 months
- unable to give informed written consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Fibroscan Baseline questionnaire filled out at recruitment. Invited to an examination of the liver, by fibroscan and blood samples, shortly after recruitment. Follow-up by phone after 6 months. Control Fibroscan Baseline questionnaire filled out at recruitment. Follow-up by phone after 6 months. Invited to an optional examination of the liver, by fibroscan and blood samples, after 6 months. Control Blood samples Baseline questionnaire filled out at recruitment. Follow-up by phone after 6 months. Invited to an optional examination of the liver, by fibroscan and blood samples, after 6 months. Intervention Blood samples Baseline questionnaire filled out at recruitment. Invited to an examination of the liver, by fibroscan and blood samples, shortly after recruitment. Follow-up by phone after 6 months.
- Primary Outcome Measures
Name Time Method Recruitment 6 months \>50% of those invited to participate gives written consent.
Retention 6 months \>50% of those recruited and randomized to an examination, will attend for an examination at the hospital
Completion 6 months after randomization \>50% of randomized patients complete follow-up
- Secondary Outcome Measures
Name Time Method Abstinence or reduction in alcohol consumption 10 months Abstinence from alcohol in the three months prior to the 6-months follow-up phone call.
Reduction in AUDIT score 10 months AUDIT score is reported at baseline, and again at the 6 months follow up phone call.
Prevalence of fibrosis/cirrhosis in individuals in alcohol treatment 6 months Results from fibroscan, with a mean value of \>8 indicating fibrosis and a mean value of \>15 indicating cirrhosis.
Reduction in Number of heavy drinking days 10 months Reduction in Number of heavy drinking days, data collected at follow-up after 6 months, compared to baseline data.
Trial Locations
- Locations (1)
Department of Medicine, Zealand University Hospital
🇩🇰Køge, Denmark