Clinical trial NCT05244720: Evaluation of Liver Disease in Individuals Attending Alcohol Abuse Treatment - a Randomized Controlled Pilot Trial
Official title: Evaluation of Liver Disease in Individuals Attending Alcohol Abuse Treatment - a Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Diseases
Keywords: alcohol
pilot study
feasibility
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2022-02-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot study to determine feasibility
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Recruitment
timeFrame: 6 months
measure: Retention
timeFrame: 6 months
measure: Completion
timeFrame: 6 months after randomization
Secondary outcomes:
measure: Reduction in Number of heavy drinking days
timeFrame: 10 months
measure: Abstinence or reduction in alcohol consumption
timeFrame: 10 months
measure: Prevalence of fibrosis/cirrhosis in individuals in alcohol treatment
timeFrame: 6 months
measure: Reduction in AUDIT score
timeFrame: 10 months
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Department of Medicine, Zealand University Hospital
Study officials:
affiliation: Department of Medicine, Zealand University Hospital
name: Gro Askgaard, PhD
role: STUDY_CHAIR
affiliation: Department of Medicine, Zealand University Hospital
name: Lone Madsen, PhD
role: PRINCIPAL_INVESTIGATOR
References: