Quality of Life in Patients With Alcohol Use Disorder (QUALIFACT)

July 30, 2025 updated by: Hôpital le Vinatier

Factors Associated With Quality of Life in Patients With Alcohol Use Disorder

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

167

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Auvergne Rhone Alpes
      • Bron, Auvergne Rhone Alpes, France, 69678 cedex
        • Centre Hospitalier le Vinatier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life in patients with AUD.
Time Frame: Within the 10th and 21st day of the detoxification program (baseline assessment).
Alcohol Quality of Life Scale.
Within the 10th and 21st day of the detoxification program (baseline assessment).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life in patients with AUD 6 months after the detoxification program.
Time Frame: 6 months after the baseline assessment.
Alcohol Quality of Life Scale.
6 months after the baseline assessment.
Alcohol status
Time Frame: 6 months after the baseline assessment.
Alcohol (relapse/abstinence)
6 months after the baseline assessment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital le Vinatier

Investigators

  • Study Director: LOUIS FERDINAND LESPINE, MD, CH Le Vinatier
  • Principal Investigator: Benjamin ROLLAND, MD, PhD, CH Le Vinatier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2021

Primary Completion (Actual)

August 8, 2024

Study Completion (Actual)

January 21, 2025

Study Registration Dates

First Submitted

January 19, 2021

First Submitted That Met QC Criteria

February 8, 2021

First Posted (Actual)

February 10, 2021

Study Record Updates

Last Update Posted (Actual)

July 31, 2025

Last Update Submitted That Met QC Criteria

July 30, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A02853-36

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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