Quality of Life in Patients With Alcohol Use Disorder

Not Applicable

• Conditions: Alcohol Use Disorder
• Interventions: Other: questionnaires

• Registration Number: NCT04748822
• Lead Sponsor: Hôpital le Vinatier

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).

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 Timeline

• Study First Submitted: 2021-01-19
• Study First Submitted QC: 2021-02-08
• Study First Posted: 2021-02-10
• Study Start: 2021-03-25
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-11
• Last Update Posted: 2022-08-12
• Primary Completion: 2023-02-28
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Quality of life of patients with AUD.	questionnaires	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Alcohol status	6 months after the baseline assessment.	Alcohol (relapse/abstinence)
Quality of life in patients with AUD 6 months after the detoxification program.	6 months after the baseline assessment.	Alcohol Quality of Life Scale.

Trial Locations

Locations (1)

Centre Hospitalier Le Vinatier; 🇫🇷 Bron, Auvergne Rhone Alpes, France