Quality of Life in Patients With Alcohol Use Disorder

Alcohol Use Disorder Clinical Trial

— QUALIFACT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04748822
• Other study ID #: 2020-A02853-36
• Status: Recruiting
• Phase: N/A
• Start date: March 25, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: August 2022
• Source: Hôpital le Vinatier
• Contact: Benjamin ROLLAND, MD, PhD
• Phone: +33 437 915 555
• Email: benjamin.rolland[@]ch-le-vinatier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 30, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

Intervention

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.

Locations

Country	Name	City	State
France	Centre Hospitalier Le Vinatier	Bron	Auvergne Rhone Alpes

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital le Vinatier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life in patients with AUD.	Alcohol Quality of Life Scale.	Within the 10th and 21st day of the detoxification program (baseline assessment).
Secondary	Quality of life in patients with AUD 6 months after the detoxification program.	Alcohol Quality of Life Scale.	6 months after the baseline assessment.
Secondary	Alcohol status	Alcohol (relapse/abstinence)	6 months after the baseline assessment.