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

Primary Purpose

Liver Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Fibroscan
Blood samples
Sponsored by
Zealand University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Liver Diseases focused on measuring alcohol, pilot study, feasibility

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Medicine, Zealand University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Recruitment
>50% of those invited to participate gives written consent.
Retention
>50% of those recruited and randomized to an examination, will attend for an examination at the hospital
Completion
>50% of randomized patients complete follow-up

Secondary Outcome Measures

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.
Abstinence or reduction in alcohol consumption
Abstinence from alcohol in the three months prior to the 6-months follow-up phone call.
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.
Reduction in AUDIT score
AUDIT score is reported at baseline, and again at the 6 months follow up phone call.

Full Information

First Posted
February 7, 2022
Last Updated
February 16, 2022
Sponsor
Zealand University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05244720
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
August 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zealand University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Diseases
Keywords
alcohol, pilot study, feasibility

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pilot study to determine feasibility
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Other
Arm Description
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 Type
Diagnostic Test
Intervention Name(s)
Fibroscan
Other Intervention Name(s)
Transient elastography
Intervention Description
A percutaneous scan, that measures shear wave velocity. It estimates liver stiffness.
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood samples
Intervention Description
Blood samples to asses the function of liver, kidney and bone marrow, as well as nutrition/vitamin status.
Primary Outcome Measure Information:
Title
Recruitment
Description
>50% of those invited to participate gives written consent.
Time Frame
6 months
Title
Retention
Description
>50% of those recruited and randomized to an examination, will attend for an examination at the hospital
Time Frame
6 months
Title
Completion
Description
>50% of randomized patients complete follow-up
Time Frame
6 months after randomization
Secondary Outcome Measure Information:
Title
Reduction in Number of heavy drinking days
Description
Reduction in Number of heavy drinking days, data collected at follow-up after 6 months, compared to baseline data.
Time Frame
10 months
Title
Abstinence or reduction in alcohol consumption
Description
Abstinence from alcohol in the three months prior to the 6-months follow-up phone call.
Time Frame
10 months
Title
Prevalence of fibrosis/cirrhosis in individuals in alcohol treatment
Description
Results from fibroscan, with a mean value of >8 indicating fibrosis and a mean value of >15 indicating cirrhosis.
Time Frame
6 months
Title
Reduction in AUDIT score
Description
AUDIT score is reported at baseline, and again at the 6 months follow up phone call.
Time Frame
10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Natasja von Wowern, MD
Phone
+4527522833
Email
naav@regionsjaelland.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gro Askgaard, PhD
Organizational Affiliation
Department of Medicine, Zealand University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lone Madsen, PhD
Organizational Affiliation
Department of Medicine, Zealand University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine, Zealand University Hospital
City
Køge
ZIP/Postal Code
4600
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natasja von Wowern
Phone
+4527522833
Email
naav@regionsjaelland.dk

12. IPD Sharing Statement

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

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