Evaluation of Liver Disease in Individuals Attending Alcohol Abuse Treatment - a Randomized Controlled Pilot Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Liver Diseases
- Sponsor
- Zealand University Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Retention
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Retention
Time Frame: 6 months
\>50% of those recruited and randomized to an examination, will attend for an examination at the hospital
Completion
Time Frame: 6 months after randomization
\>50% of randomized patients complete follow-up
Recruitment
Time Frame: 6 months
\>50% of those invited to participate gives written consent.
Secondary Outcomes
- Prevalence of fibrosis/cirrhosis in individuals in alcohol treatment(6 months)
- Abstinence or reduction in alcohol consumption(10 months)
- Reduction in AUDIT score(10 months)
- Reduction in Number of heavy drinking days(10 months)