NCT04490330

Brief Summary

80% of patients with alcohol use disorders (AUD) present cognitive impairments, such as memory and executive functions. These disorders may have repercussions in addiction treatment by altering the patient's adherence to care. The level of impairment is dependent on the onset of addiction, and also the duration of abstinence. A complete neuropsychological evaluation is necessary to highlight cognitive impairments. In practice, the evaluation of these disorders by practitioners, is done with the help of tools of screening like the MoCa (Montreal cognitive assesment) and the BEARNI (Brief evaluation of alcohol related neuropsychological impairment). However, none of these tools have been evaluated in patients with alcoholic cirrhosis. Indeed, some studies have suggested that liver disorders including cirrhosis may be a factor aggravating cognitive disorders. The purpose of this study is to evaluate the ability of the BEARNI tool to detect alcohol-related cognitive problems in patients with alcohol-related cirrhosis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 24, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 29, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

August 1, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

3 years

First QC Date

July 24, 2020

Last Update Submit

February 7, 2023

Conditions

Keywords

Alcohol DependenceDependenceCognitive ImpairmentsCirrhosisLiver Diseases

Outcome Measures

Primary Outcomes (1)

  • number of alcoholic cirrhosis patients with presence of alcohol-related cognitive disorders

    the number of alcoholic cirrhosis patients with presence of alcohol-related cognitive disorders will be measured by using the BEARNI screening tool. BEARNI screening tool is Brief evaluation of alcohol related neuropsychological impairment.

    day 1

Interventions

AUDIT questionnaire (alcohol use disorders identification test)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with alcoholic cirrhosis will be evaluated with BEARNI tool in order to detect alcohol-related cognitive problems.

You may qualify if:

  • Patient with cirrhosis
  • patients with cirrhosis diagnosed by clinical examination
  • patients with cirrhosis diagnosed by biological and / or morphological and / or noninvasive tests and / or liver biopsy
  • CHILD A, B or C

You may not qualify if:

  • hepatitis encephalopathy less than 6 months old
  • complicated cirrhosis with hepatocellular carcinoma
  • Acute alcoholic hepatitis
  • viral cirrhosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80480, France

RECRUITING

MeSH Terms

Conditions

AlcoholismCognitive DysfunctionFibrosisLiver Diseases

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersCognition DisordersNeurocognitive DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsDigestive System Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2020

First Posted

July 29, 2020

Study Start

August 1, 2020

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations