Liver Diseases
Conditions
Keywords
alcohol, pilot study, feasibility
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.
Interventions
DIAGNOSTIC_TESTFibroscan
A percutaneous scan, that measures shear wave velocity. It estimates liver stiffness.
DIAGNOSTIC_TESTBlood samples
Blood samples to asses the function of liver, kidney and bone marrow, as well as nutrition/vitamin status.
Sponsors
Zealand University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Intervention model description
Pilot study to determine feasibility
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment | 6 months | \>50% of those invited to participate gives written consent. |
| Retention | 6 months | \>50% of those recruited and randomized to an examination, will attend for an examination at the hospital |
| Completion | 6 months after randomization | \>50% of randomized patients complete follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Number of heavy drinking days | 10 months | Reduction in Number of heavy drinking days, data collected at follow-up after 6 months, compared to baseline data. |
| Reduction in AUDIT score | 10 months | AUDIT score is reported at baseline, and again at the 6 months follow up phone call. |
| Abstinence or reduction in alcohol consumption | 10 months | 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 | 6 months | Results from fibroscan, with a mean value of \>8 indicating fibrosis and a mean value of \>15 indicating cirrhosis. |
Countries
Denmark
Outcome results
None listed