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QUALIFACT: Quality of Life in Patients With Alcohol Use Disorder

Sponsor
Hôpital le Vinatier (Other)
Overall Status
Recruiting
CT.gov ID
NCT04748822
Collaborator
(none)
200
Enrollment
1
Location
1
Arm
30.2
Anticipated Duration (Months)
6.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary purpose of this study is to investigate the factors associated with quality of life of patients with alcohol use disorder (AUD) undergoing a detoxification program (cross-sectional analysis). The secondary purpose is (1) to identify the factors associated with change in quality of life between baseline and 6-month follow-up, and (2) to identify the factors associated with alcohol relapse at 6 months (longitudinal analyses).

Condition or Disease Intervention/Treatment Phase
  • Other: questionnaires
 N/A

Detailed Description

The standard DSM-5-based clinical assessment of AUD includes the number of AUD criteria (between 2 and 11) as well as various parameters related to the patterns of alcohol use (e.g., frequency of use, frequency of heavy use). In the contemporary clinical practice, more "functional" assessment tools are emerging such as quality of life, autonomy, cognitive functioning, but also other non-specific lifestyle habits, such as sleep quality and sexual functioning. These indicators are important because they define the broad impact of AUD on individual's life, and they are part of the overall rehabilitation, beyond the mere question of the relationship to alcohol. However, the determinants of quality of life of patients with AUD patients undergoing a detoxification program, and the factors associated with change in quality of life are not well identified.

This prospective cohort study will recruit 200 patients undergoing a detoxification program (home-based or in addiction services). Patients' demographic data, socioeconomic status, physical diseases, medication use, clinical features of AUD, psychiatric variables, impulsivity, autonomy, sexual functioning, sleep quality, and cognitive functioning will be measured at baseline. The Alcohol Quality of Life Scale (AQoLS) will be completed at baseline and at 6-month follow-up. Alcohol status (relapse/abstinence) will be assessed at 6 months.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Prospective cohort studyProspective cohort study
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Factors Associated With Quality of Life in Patients With Alcohol Use Disorder
Actual Study Start Date :
Mar 25, 2021
Anticipated Primary Completion Date :
Feb 28, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: Quality of life of patients with AUD.

Patients' demographic data, socioeconomic status, physical diseases, medication use, clinical features of AUD, psychiatric variables, impulsivity, autonomy, sexual functioning, sleep quality, and cognitive functioning will be measured at baseline. The Alcohol Quality of Life Scale (AQoLS) will be completed at baseline and at 6-month follow-up. Alcohol status (relapse/abstinence) will be assessed at 6 months.

Other: questionnaires
The Alcohol Quality of Life Scale (AQoLS) will be completed at baseline and at 6-month follow-up. Alcohol status (relapse/abstinence) will be assessed at 6 months.
Other Names:
  • Alcohol Quality of Life Scale (AQoLS) and Alcohol status

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Quality of life in patients with AUD. [Within the 10th and 21st day of the detoxification program (baseline assessment).]

      Alcohol Quality of Life Scale.

    Secondary Outcome Measures

    1. Quality of life in patients with AUD 6 months after the detoxification program. [6 months after the baseline assessment.]

      Alcohol Quality of Life Scale.

    2. Alcohol status [6 months after the baseline assessment.]

      Alcohol (relapse/abstinence)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • DSM-5 AUD criteria

    • At least 18 years of age

    • Within the 10th and 21st day of a detoxification program.

    Exclusion Criteria:

    • Communication difficulties (insufficient level of French, major hearing or visual impairment, major cognitive deficit)

    • Under guardianship

    • Under justice control

    • Cannot be reached by phone

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre Hospitalier Le Vinatier Bron Auvergne Rhone Alpes France 69678 cedex

    Sponsors and Collaborators

    • Hôpital le Vinatier

    Investigators

    • Principal Investigator: Benjamin ROLLAND, MD, PhD, CH LE VINATIER
    • Study Director: LOUIS FERDINAND LESPINE, MD, CH LE VINATIER

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hôpital le Vinatier
    ClinicalTrials.gov Identifier:
    NCT04748822
    Other Study ID Numbers:
    • 2020-A02853-36
    First Posted:
    Feb 10, 2021
    Last Update Posted:
    Aug 12, 2022
    Last Verified:
    Aug 1, 2022
    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
    Additional relevant MeSH terms:
    Alcoholism
    Alcohol Drinking
    Ethanol

    Study Results

    No Results Posted as of Aug 12, 2022