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

February 16, 2022 updated by: Zealand University Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Køge, Denmark, 4600
        • Recruiting
        • Department of Medicine, Zealand University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention

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
A percutaneous scan, that measures shear wave velocity. It estimates liver stiffness.
Other Names:
  • Transient elastography
Diagnostic test: Blood samples
Blood samples to asses the function of liver, kidney and bone marrow, as well as nutrition/vitamin status.
Other: Control
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
A percutaneous scan, that measures shear wave velocity. It estimates liver stiffness.
Other Names:
  • Transient elastography
Diagnostic test: Blood samples
Blood samples to asses the function of liver, kidney and bone marrow, as well as nutrition/vitamin status.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment
Time Frame: 6 months
>50% of those invited to participate gives written consent.
6 months
Retention
Time Frame: 6 months
>50% of those recruited and randomized to an examination, will attend for an examination at the hospital
6 months
Completion
Time Frame: 6 months after randomization
>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
Time Frame: 10 months
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
Time Frame: 10 months
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
Time Frame: 6 months
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
Time Frame: 10 months
AUDIT score is reported at baseline, and again at the 6 months follow up phone call.
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zealand University Hospital

Investigators

  • Study Chair: Gro Askgaard, PhD, Department of Medicine, Zealand University Hospital
  • Principal Investigator: Lone Madsen, PhD, Department of Medicine, Zealand University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

August 1, 2022

Study Registration Dates

First Submitted

February 7, 2022

First Submitted That Met QC Criteria

February 16, 2022

First Posted (Actual)

February 17, 2022

Study Record Updates

Last Update Posted (Actual)

February 17, 2022

Last Update Submitted That Met QC Criteria

February 16, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJ-934

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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