NCT05244720

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 17, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

May 13, 2024

Status Verified

January 1, 2022

Enrollment Period

11 months

First QC Date

February 7, 2022

Last Update Submit

May 8, 2024

Conditions

Liver Diseases

Keywords

alcoholpilot studyfeasibility

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • Reduction in Number of heavy drinking days

    10 months

  • Abstinence or reduction in alcohol consumption

    10 months

  • Prevalence of fibrosis/cirrhosis in individuals in alcohol treatment

    6 months

  • Reduction in AUDIT score

    10 months

Study Arms (2)

Intervention

EXPERIMENTAL

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: FibroscanDiagnostic Test: Blood samples

Control

OTHER

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: FibroscanDiagnostic Test: Blood samples

Interventions

FibroscanDIAGNOSTIC_TEST

A percutaneous scan, that measures shear wave velocity. It estimates liver stiffness.

Also known as: Transient elastography
ControlIntervention
Blood samplesDIAGNOSTIC_TEST

Blood samples to asses the function of liver, kidney and bone marrow, as well as nutrition/vitamin status.

ControlIntervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • must be enrolled at alcohol treatment center Novavi Koege, Denmark
  • Maximum 6 months of treatment at Novavi Koege

You may not qualify if:

  • known severe liver disease
  • life expectancy less than 6 months
  • unable to give informed written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine, Zealand University Hospital

Køge, 4600, Denmark

Location

Related Publications (1)

  • Jepsen P, von Wowern N, Madsen LG, Klausen MK, During S, Benthien KS, Winther-Jensen M, Petersen J, Askgaard G. The LIVER CARE trial - screening for liver disease in individuals attending treatment for alcohol use disorder: a randomized controlled feasibility trial. Pilot Feasibility Stud. 2024 May 16;10(1):78. doi: 10.1186/s40814-024-01504-5.

    PMID: 38755732DERIVED

MeSH Terms

Conditions

Liver Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Gro Askgaard, PhD

    Department of Medicine, Zealand University Hospital

    STUDY CHAIR

  • Lone Madsen, PhD

    Department of Medicine, Zealand University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Pilot study to determine feasibility
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2022

First Posted

February 17, 2022

Study Start

November 1, 2021

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

May 13, 2024

Record last verified: 2022-01

Locations

DK(1)