Liver DiseasesNCT05244720
Evaluation of Liver Disease in Individuals Attending Alcohol Abuse Treatment - a Randomized Controlled Pilot Trial
A study testing Fibroscan and Blood samples in people with Liver Diseases, run by Zealand University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Diseases
- What is being tested?
- Fibroscan and Blood samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2021to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- must be enrolled at alcohol treatment center Novavi Koege, Denmark
- Maximum 6 months of treatment at Novavi Koege
Who cannot join
- known severe liver disease
- life expectancy less than 6 months
- unable to give informed written consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Liver Diseases
- Being tested
- Fibroscan, Blood samples
- Keywords
- alcohol, pilot study, feasibility
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibroscanDiagnostic test
Also called Transient elastography
A percutaneous scan, that measures shear wave velocity. It estimates liver stiffness.
Blood samplesDiagnostic test
Blood samples to asses the function of liver, kidney and bone marrow, as well as nutrition/vitamin status.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Fibroscan; Diagnostic 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. Receives: Diagnostic Test: Fibroscan; Diagnostic Test: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
>50% of those invited to participate gives written consent.
Measured: 6 months
Retention
>50% of those recruited and randomized to an examination, will attend for an examination at the hospital
Measured: 6 months
Completion
>50% of randomized patients complete follow-up
Measured: 6 months after randomization
Secondary outcomes (4)
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.
Measured: 10 months
Abstinence or reduction in alcohol consumption
Abstinence from alcohol in the three months prior to the 6-months follow-up phone call.
Measured: 10 months
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.
Measured: 6 months
Reduction in AUDIT score
AUDIT score is reported at baseline, and again at the 6 months follow up phone call.
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start1 Nov 2021
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver DiseasesStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot study to determine feasibility
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gro Askgaard, PhD, Study chair, Department of Medicine, Zealand University HospitalLone Madsen, PhD, Principal investigator, Department of Medicine, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244720
- Sponsor's protocol ID
- SJ-934
- Status last verified
- Jan 2022
- First submitted
- 7 Feb 2022
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38755732
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Liver Disease in Individuals Attending Alcohol Abuse Treatment - a Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT05244720
- Acronym / sponsor ID
- SJ-934
- Conditions
- Liver Diseases
- Keywords
- alcohol, pilot study, feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Pilot study to determine feasibility
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Diagnostic Test: Fibroscan, Diagnostic Test: Blood samplesBaseline 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. |
| Control | Other | Diagnostic Test: Fibroscan, Diagnostic Test: Blood samplesBaseline 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- must be enrolled at alcohol treatment center Novavi Koege, Denmark
- Maximum 6 months of treatment at Novavi Koege
Key exclusion criteria (3 listed)
- known severe liver disease
- life expectancy less than 6 months
- unable to give informed written consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FibroscanAlso: Transient elastographyA percutaneous scan, that measures shear wave velocity. It estimates liver stiffness. | Diagnostic test | Control, Intervention |
| Blood samplesBlood samples to asses the function of liver, kidney and bone marrow, as well as nutrition/vitamin status. | Diagnostic test | Control, Intervention |
Primary outcome
Recruitment
Time frame: 6 months
>50% of those invited to participate gives written consent.
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
4 secondary outcomes
Reduction in Number of heavy drinking days
Time frame: 10 months
Abstinence or reduction in alcohol consumption
Time frame: 10 months
Prevalence of fibrosis/cirrhosis in individuals in alcohol treatment
Time frame: 6 months
Reduction in AUDIT score
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Derived from this study: PubMed 38755732Jepsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gro Askgaard, PhD study chair
Department of Medicine, Zealand University Hospital
Lone Madsen, PhD principal investigator
Department of Medicine, Zealand University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fibroscan and Blood samples in people with Liver Diseases, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05244720, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.