Evaluation of Liver Disease in Individuals Attending Alcohol Abuse Treatment - a Randomized Controlled Pilot Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of Liver Disease in Individuals Attending Alcohol Abuse Treatment - a Randomized Controlled Pilot Trial

Conditions
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Liver Diseases

Intervention / Treatment
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* Diagnostic Test: Fibroscan
* Diagnostic Test: Blood samples


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: must be enrolled at alcohol treatment center Novavi Koege, Denmark Maximum 6 months of treatment at Novavi Koege Exclusion Criteria: known severe liver disease life expectancy less than 6 months unable to give informed written consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Pilot study to determine feasibility
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Diagnostic Test: Fibroscan<br>* A percutaneous scan, that measures shear wave velocity. It estimates liver stiffness.<br>* Other names: Transient elastography;Diagnostic Test: Blood samples<br>* Blood samples to asses the function of liver, kidney and bone marrow, as well as nutrition/vitamin status.<br>|
| Other: Control<br>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. | Diagnostic Test: Fibroscan<br>* A percutaneous scan, that measures shear wave velocity. It estimates liver stiffness.<br>* Other names: Transient elastography;Diagnostic Test: Blood samples<br>* Blood samples to asses the function of liver, kidney and bone marrow, as well as nutrition/vitamin status.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment | >50% of those invited to participate gives written consent. | 6 months | 
| Retention | >50% of those recruited and randomized to an examination, will attend for an examination at the hospital | 6 months | 
| Completion | >50% of randomized patients complete follow-up | 6 months after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Number of heavy drinking days | Reduction in Number of heavy drinking days, data collected at follow-up after 6 months, compared to baseline data. | 10 months | 
| Abstinence or reduction in alcohol consumption | Abstinence from alcohol in the three months prior to the 6-months follow-up phone call. | 10 months | 
| Prevalence of fibrosis/cirrhosis in individuals in alcohol treatment | Results from fibroscan, with a mean value of >8 indicating fibrosis and a mean value of >15 indicating cirrhosis. | 6 months | 
| Reduction in AUDIT score | AUDIT score is reported at baseline, and again at the 6 months follow up phone call. | 10 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alcohol, pilot study, feasibility