CirCo: Screening for Alcohol-related Cognitive Impairments in Cirrhotic Patients

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Recruiting
CT.gov ID
NCT04490330
Collaborator
(none)
100
1
24
4.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: questionnaire

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Screening for Alcohol-related Cognitive Impairments in Cirrhotic Patients
Actual Study Start Date :
Aug 1, 2020
Actual Primary Completion Date :
Aug 1, 2021
Anticipated Study Completion Date :
Aug 1, 2022

Outcome Measures

Primary Outcome Measures

  1. number of alcoholic cirrhosis patients with presence of alcohol-related cognitive disorders [day 1]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • hepatitis encephalopathy less than 6 months old

  • complicated cirrhosis with hepatocellular carcinoma

  • Acute alcoholic hepatitis

  • viral cirrhosis

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Amiens Amiens France 80480

Sponsors and Collaborators

  • Centre Hospitalier Universitaire, Amiens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT04490330
Other Study ID Numbers:
  • PI2019_843_0106
First Posted:
Jul 29, 2020
Last Update Posted:
Sep 8, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire, Amiens
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 8, 2021